SLIMM-T2D: Surgery or Lifestyle With Intensive Medical Management in the Treatment of Type 2 Diabetes
Study Details
Study Description
Brief Summary
There is substantial clinical evidence regarding the safety and efficacy of currently practiced bariatric surgical techniques to improve metabolic control and/or resolve type 2 diabetes (T2DM) in clinically severe obese patients (class 3 obesity). Evidence suggests such procedures have greater effects on insulin secretion and insulin action than that expected from weight loss alone, which has led to the recent claim that such procedures may be useful as a primary treatment for T2DM in the moderately obese population. Concurrently, there have also been substantial advances in the non-surgical medical management of T2DM. As a result, the best treatment algorithm for T2DM patients with class 1 & 2 obesity is increasingly controversial. This trial investigates the utility of currently practiced and available bariatric surgical procedures as compared with multidisciplinary intensive medical and weight management for the treatment of T2DM with class 1 and 2 obesity.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
Primary Specific Aim 1: To evaluate the effectiveness of laparoscopic adjustable gastric band versus intensive medical and weight management in the treatment of T2DM.
There has been only one randomized control trial to date comparing surgical to medical management of T2DM in the less obese population, which demonstrated substantial superiority of the laparoscopic adjustable gastric band (LAGB) in the improvement of glycemic and metabolic measures. However, these findings remain controversial as the magnitude of weight loss in this study was far superior to that generally reported following LAGB. Thus, we propose a second prospective randomized trial to evaluate the effectiveness of intensive medical and weight management (IMWM) vs. LAGB in T2DM patients with BMI in the 30-42 kg/m^2 range. This range does extend LAGB surgery to BMI limits below those currently used in medical care, FDA Investigational Device Exemption (IDE) G090163. The primary outcome variable will be attaining glycemic control (as defined by fasting plasma glucose levels <126 mg/dL and HbA1c <6.5%) at one year of follow-up. The study was subsequently extended to 3 years, with the same outcome measures.
Primary Specific Aim 2: To evaluate the effectiveness of laparoscopic Roux-en-Y gastric bypass versus intensive medical and weight management in the treatment of T2DM.
Although observational studies and meta-analyses suggest rapid and sustained improvement or resolution of diabetes following laparoscopic Roux-en-Y gastric bypass (LRYGB), to date there has been no randomized trial directly comparing these effects to those produced by IMWM. We propose a prospective randomized trial comparing the effectiveness of IMWM vs. LRYGB in T2DM patients with BMI's in the 30-42 kg/m^2 range. This range extends LRYGB surgery to BMI limits below those currently used in medical care to explore the use of this type of surgical procedure in type 2 diabetes with lesser magnitude obesity. The primary outcome variable will be attaining glycemic control (as defined by fasting plasma glucose levels <126 mg/dL and HbA1c <6.5%) at one year of follow-up. The study was subsequently extended to 3 years, with the same outcome measures.
The trial is designed to allow for strong patient preference towards specific surgical procedures, and as such is designed as two parallel trials with each of the two surgical procedures judged against intensive medical weight management. Subjects without strong preference will be randomly assigned to one of the four study arms.
Secondary Specific Aims:
Determination of suitable study design: In addition to testing the effectiveness of current and available surgical techniques as compared to medical management, this trial will also test the utility of this trial design in future multi-institutional comparative effectiveness studies of these therapies, or alternatively, in future trials evaluating new surgical procedures being designed specifically for less obese T2DM patients.
Measurement of metabolic factors: Insulin secretion and action will be assessed during provocative mixed meal tolerance tests (MMTT) using the corrected incremental insulin response (CIR) and the composite insulin sensitivity index (CISI). MMTT will be performed in all groups at baseline and repeated at the time point of 10% weight loss (matched for weight loss), and at 12 months following randomization (matched for time).
Measurement of cardiovascular risk factors: Each group will be studied for evidence of changes in cardiovascular disease risk factors. Multiple surrogate measures of cardiovascular health will be compared, including blood pressure, fasting lipid profiles, endothelium-dependent vasodilatation and plasma will be collected for circulating markers of endothelial function. The study was subsequently extended to 3 years, with the same outcome measures.
Measurement of metabolic rate: Each group will be studied for change in energy expenditure and respiratory quotient using the non-invasive indirect calorimetry technique.
Quality of life and cost utility outcomes: Longitudinal measures of patient reported quality of life outcomes, and cost utility measures will also be collected to generate preliminary data for future studies.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Gastric Band vs Intensive Diabetes & Weight Management Patients will be randomized to receive either 1) laparoscopic placement of an adjustable gastric band (LAGB) or 2) treatment with an intensive medical and weight management (IMWM) program. LAGB will be placed using the "pars flaccida" technique. The Allergan laparoscopic band "LAP BAND" system will be utilized. LAGB ports will be placed in subcutaneous pockets in the right upper abdomen. The IMWM group will participate in the Weight Achievement and Intensive Treatment (Why WAIT) program, which is a multidisciplinary program for weight control and intensive diabetes management designed by Joslin Diabetes Center. Key aspects include: 1) Intensive and interactive medication adjustments, 2) Structured modified dietary intervention, 3) Graded, balanced, and individualized exercise intervention, 4) Cognitive behavioral intervention and 5) Group education. |
Device: Allergan Adjustable Gastric Band Surgery
Other: Intensive Medical Diabetes & Weight Management (Why WAIT) - Band Group
Intensive Medical Diabetes & Weight Management (Why WAIT) - Band Group
|
| Active Comparator: RYGB vs Intensive Diabetes & Weight Management Patients will be randomized to receive either 1) Roux-en-Y gastric bypass (RYGB) surgery or 2) treatment with an intensive medical and weight management (IMWM) program. RYGB will be performed using a 75 cm antecolic, ante-gastric Roux limb created with a 50 cm pancreaticobiliary limb. A 15-20 cc gastric pouch will be created lying along the lesser curve of the stomach, with division of the vagal trunks at the lower border of the pouch. The IMWM group will participate in the Weight Achievement and Intensive Treatment (Why WAIT) program, which is a multidisciplinary program for weight control and intensive diabetes management designed by Joslin Diabetes Center. Key aspects include: 1) Intensive and interactive medication adjustments, 2) Structured modified dietary intervention, 3) Graded, balanced, and individualized exercise intervention, 4) Cognitive behavioral intervention and 5) Group education. |
Procedure: Roux-en-Y Gastric Bypass (RYGB) Surgery
Other: Intensive Medical Diabetes & Weight Management (Why WAIT) - Bypass Group
Intensive Medical Diabetes & Weight Management (Why WAIT) - Bypass Group
|
Outcome Measures
Primary Outcome Measures
- Fasting Plasma Glucose <126 mg/dL and HbA1c < 6.5% at Three Years of Follow-up. [3 years]
The primary outcome variable of both parallel trials will be the percent of patients attaining glycemic control (defined as fasting plasma glucose < 126 mg/dL and HbA1c < 6.5%) at three years of follow-up.
Secondary Outcome Measures
- Glycemic Control, as Measured by Hemoglobin A1c [3 years]
All participants had type 2 diabetes. Long-term diabetes control is typically evaluated in both clinical and research settings using the measurement of Hemoglobin A1c (a measure of glycated hemoglobin, proportional to average glucose levels over approximately 3 months). This endpoint (hemoglobin A1c) was measured at 3 years after intervention. Reported values are changes from baseline derived from the mixed effects model analysis, adjusted for baseline.
- Body Mass Index [3 years]
Change in body mass index 3 years after intervention
- Cardiovascular Risk [3 years]
UKPDS risk of coronary heart disease, reported as change from baseline
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Potential participants will be those with T2DM, with a diagnosis of diabetes of at least one year in duration,
-
BMI 30-45 kg/m2 for the LAGB compared to intensive medical weight and diabetes management and BMI 30-42 kg/m2 for LRYGB compared to intensive medical weight and diabetes management,
-
Age 21-65 years,
-
With a strong desire for substantial weight loss, who are free from active cardiovascular or other diseases that would render them unable to partake in a structured exercise program or to undergo a bariatric surgical procedure, and who are committed to life long medical and nutritional follow up.
Exclusion Criteria:
-
Detectable levels of glutamic acid decarboxylase (GAD) antibody or a history of diabetic ketoacidosis or uncontrolled T2DM (consistent fasting blood glucose >200 mg/dl or HbA1c above twice normal);
-
Previous gastrointestinal surgery, inflammatory bowel disease, esophageal diseases including severe intractable esophagitis, Barrett's Disease, esophageal dysmotility or other impaired gastric motility (gastroparesis), or hiatal hernia >3 cm in size, chronic or acute bleeding conditions including peptic ulcer disease, portal hypertension (gastric or esophageal varices), chronic pancreatitis, or cirrhosis of the liver;
-
Malignant or debilitating medical conditions, severe cardiopulmonary disease including uncontrolled hypertension (repeated systolic measures >160 or diastolic > 95 mm Hg on more than one day), unstable angina pectoris, recent myocardial infarction within 6 months, history of coronary artery bypass surgery or angioplasty, congestive heart failure, arrhythmia, stroke or transient ischemic attacks, urinary albumin excretion
300 mcg/mg creatinine and/or serum creatinine >1.5 mg/dL (permitting safety of increased dietary protein intake),
-
Any endocrine disorder other than T2DM or thyroid disease which is stable on replacement therapy, including Cushing's syndrome;
-
Any previous history of eating disorders, history of drug and/or alcohol abuse within 2 years of the screening visit, history of impaired mental status as defined by Diagnostic and Statistical Manual, 4th Edition (DSM-4) criteria and including, but not limited to active substance abuse, a history of schizophrenia, borderline personality disorder, uncontrolled depression, suicidal attempts within the past two years or current suicidal tendencies or ideations.
-
Subjects will be excluded if there is a history of significant weight loss (>3%) within the previous 3 months or participation in alternate medically supervised exercise or weight reduction program within the previous 3 months, or with use of prescription or over the counter weight reduction medications or supplements within one month of the Screening Visit and for the duration of study participation.
-
Women who are lactating, planning pregnancy, or unwilling to use contraception during the course of the trial.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Brigham and Women's Hospital | Boston | Massachusetts | United States | 02215 |
| 2 | Joslin Diabetes Center | Boston | Massachusetts | United States | 02215 |
Sponsors and Collaborators
- Joslin Diabetes Center
- Brigham and Women's Hospital
Investigators
- Principal Investigator: Allison B. Goldfine, MD, Joslin Diabetes Center
- Principal Investigator: Ashley Vernon, MD, Brigham and Women's Hospital
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
- 2009P-001610
Study Results
Participant Flow
| Recruitment Details | Patients will be recruited from the Joslin Diabetes Center and Partners Healthcare. All patients with type 2 diabetes (T2DM) attending the Brigham and Women's Hospital (BWH) Bariatric Surgery Program orientation sessions (>1200 subjects/year) will be presented with this trial as an option. Recruitment will also be from the >13,000 T2DM patients who receive their medical care at Joslin Diabetes Center or the Partners Healthcare Primary Care Network. |
|---|---|
| Pre-assignment Detail | After initial contact, patients will undergo the following: 1) Telephone screening (review inclusion and exclusion criteria, description of interventions), 2) Attend clinical trial orientation session (detailed description of interventions, protocol, procedures, surgical clearance, nutritional evaluation, risks, benefits), 3) Medical and surgical screening visit (sign informed consent, screening lab tests, history and physical, psychological evaluation for bariatric surgery, exercise clearance). |
| Arm/Group Title | Laparoscopic Adjustable Gastric Band (LAGB) | Intensive Medical Diabetes & Weight Management (LAGB Grp) | RYGB | Intensive Medical Diabetes & Weight Management (RYGB Grp) |
|---|---|---|---|---|
| Arm/Group Description | Laparoscopic Adjustable Gastric Band (LAGB): Allergan Adjustable Gastric Band (Device) Participants were randomized to LAGB vs. an intensive medical diabetes and weight management program (Why Wait? Program) | Participants were randomized to LAGB vs. an intensive medical diabetes and weight management program (Why Wait? Program) | Roux-en-Y Gastric Bypass (Surgery) Participants were randomized to RYGB vs. an intensive medical diabetes and weight management program (Why WAIT? Program) | Participants were randomized to RYGB vs. an intensive medical diabetes and weight management program (Why Wait? Program) |
| Period Title: Overall Study | ||||
| STARTED | 23 | 22 | 22 | 21 |
| COMPLETED | 16 | 17 | 19 | 19 |
| NOT COMPLETED | 7 | 5 | 3 | 2 |
Baseline Characteristics
| Arm/Group Title | Laparoscopic Adjustable Gastric Band (LAGB) | Intensive Medical Diabetes & Weight Management (LAGB Group) | RYGB | Intnnsive Medical Diabetes and Weight Management (RYGB Group) | Total |
|---|---|---|---|---|---|
| Arm/Group Description | Laparoscopic Adjustable Gastric Band: Allergan Adjustable Gastric Band (Device) | Intensive Medical Diabetes & Weight Management: Intensive Medical Diabetes & Weight Management (LAGB Group) This group selected band as preferred surgery, but were randomized to medical management. | Roux-en-Y Gastric Bypass (Surgery) | Intensive Medical Diabetes & Weight Management: Intensive Medical Diabetes & Weight Management (RYGB Group) This group selected RYGB as preferred surgery, but were randomized to medical management. | Total of all reporting groups |
| Overall Participants | 23 | 22 | 22 | 21 | 88 |
| Age (Count of Participants) | |||||
| <=18 years |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Between 18 and 65 years |
23
100%
|
22
100%
|
22
100%
|
21
100%
|
88
100%
|
| >=65 years |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Age (years) [Mean (Standard Deviation) ] | |||||
| Mean (Standard Deviation) [years] |
51.1
(12.1)
|
51.4
(7.5)
|
50.7
(7.6)
|
52.6
(4.3)
|
51.4
(8.3)
|
| Sex: Female, Male (Count of Participants) | |||||
| Female |
12
52.2%
|
9
40.9%
|
16
72.7%
|
10
47.6%
|
47
53.4%
|
| Male |
11
47.8%
|
13
59.1%
|
6
27.3%
|
11
52.4%
|
41
46.6%
|
| Region of Enrollment (participants) [Number] | |||||
| United States |
23
100%
|
22
100%
|
22
100%
|
21
100%
|
88
100%
|
Outcome Measures
| Title | Fasting Plasma Glucose <126 mg/dL and HbA1c < 6.5% at Three Years of Follow-up. |
|---|---|
| Description | The primary outcome variable of both parallel trials will be the percent of patients attaining glycemic control (defined as fasting plasma glucose < 126 mg/dL and HbA1c < 6.5%) at three years of follow-up. |
| Time Frame | 3 years |
Outcome Measure Data
| Analysis Population Description |
|---|
| Patients not analyzed include: 7 of 23 in LAGB (4 withdrew consent before intervention,1 determined to not be a surgical candidate before intervention, and 2 withdrew consent between 1 and 3 years); 5 of 22 in IMWM (LAGB Grp) (4 withdrew consent, 1 death); 3 of 22 in the RYGB group (1 withdrew consent; 1 breast cancer diagnosis and 1 psychiatric illness pre-intervention); 2 of 21 IMWM (RYGB Grp) withdrew consent before intervention. |
| Arm/Group Title | LAGB | Intensive Medical Diabetes & Weight Management (LAGB Grp) | RYGB | Intensive Medical Diabetes & Weight Management (RYGB Grp) |
|---|---|---|---|---|
| Arm/Group Description | Laparoscopic Adjustable Gastric Band: Allergan Adjustable Gastric Band (Device) Participants were randomized to LAGB vs. an intensive medical diabetes and weight management program (Why WAIT? Program) | Participants were randomized to LAGB vs. an intensive medical diabetes and weight management program (Why WAIT? Program) | Roux-en-Y Gastric Bypass (Surgery) Participants were randomized to RYGB vs. an intensive medical diabetes and weight management program (Why WAIT? Program) | Participants were randomized to RYGB vs. an intensive medical diabetes and weight management program (Why WAIT? Program) |
| Measure Participants | 16 | 17 | 19 | 19 |
| Number [% of patients] |
13
|
5
|
42
|
0
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | LAGB, Intensive Medical Diabetes & Weight Management (LAGB Grp) |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.60 |
| Comments | ||
| Method | Chi-squared | |
| Comments | ||
| Method of Estimation | Estimation Parameter | proportion |
| Estimated Value | 0.08 | |
| Confidence Interval |
(2-Sided) % to |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | Estimation parameter is the difference between the proportion of patients in the LAGB group vs. proportion of patients in the Intensive Medical Diabetes & Weight Management (LAGB Grp) who achieved the primary outcome. | |
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | RYGB, Intensive Medical Diabetes & Weight Management (RYGB Grp) |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.005 |
| Comments | ||
| Method | Chi-squared | |
| Comments | ||
| Method of Estimation | Estimation Parameter | proportion |
| Estimated Value | 0.42 | |
| Confidence Interval |
(2-Sided) % to |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | Estimation parameter is the difference between the proportion of patients in the RYGB group vs. proportion of patients in the Intensive Medical Diabetes & Weight Management (RYGB Grp) who achieved the primary outcome. | |
| Title | Glycemic Control, as Measured by Hemoglobin A1c |
|---|---|
| Description | All participants had type 2 diabetes. Long-term diabetes control is typically evaluated in both clinical and research settings using the measurement of Hemoglobin A1c (a measure of glycated hemoglobin, proportional to average glucose levels over approximately 3 months). This endpoint (hemoglobin A1c) was measured at 3 years after intervention. Reported values are changes from baseline derived from the mixed effects model analysis, adjusted for baseline. |
| Time Frame | 3 years |
Outcome Measure Data
| Analysis Population Description |
|---|
| Randomized patients who had at least one post-randomization visit (modified intention to treat). |
| Arm/Group Title | LAGB | Intensive Medical Diabetes & Weight Management (LAGB Grp) | RYGB | Intensive Medical Diabetes & Weight Management (RYGB Grp) |
|---|---|---|---|---|
| Arm/Group Description | Laparoscopic Adjustable Gastric Band: Allergan Adjustable Gastric Band (Device) Participants were randomized to LAGB vs. an intensive medical diabetes and weight management program (Why WAIT? Program) | Participants were randomized to LAGB vs. an intensive medical diabetes and weight management program (Why WAIT? Program) | Roux-en-Y Gastric Bypass (Surgery) Participants were randomized to RYGB vs. an intensive medical diabetes and weight management program (Why WAIT? Program) | Participants were randomized to RYGB vs. an intensive medical diabetes and weight management program (Why WAIT? Program) |
| Measure Participants | 16 | 17 | 19 | 19 |
| Mean (95% Confidence Interval) [Percent] |
-0.8
|
0.2
|
-1.8
|
-0.4
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | LAGB, Intensive Medical Diabetes & Weight Management (LAGB Grp) |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.33 |
| Comments | ||
| Method | Mixed Models Analysis | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Net) |
| Estimated Value | 1.0 | |
| Confidence Interval |
(2-Sided) 95% to |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | Estimation parameter is the difference between the change from baseline in HbA1c in the LAGB group vs. change from baseline in HbA1c in the Intensive Medical Diabetes & Weight Management (LAGB Grp), adjusted for baseline HbA1c. | |
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | RYGB, Intensive Medical Diabetes & Weight Management (RYGB Grp) |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | Mixed Models Analysis | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Net) |
| Estimated Value | 1.4 | |
| Confidence Interval |
(2-Sided) 95% to |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | Estimation parameter is the difference between the change from baseline in HbA1c in the RYGB group vs. change from baseline in HbA1c in the Intensive Medical Diabetes & Weight Management (RYGB Grp), adjusted for baseline HbA1c. | |
| Title | Body Mass Index |
|---|---|
| Description | Change in body mass index 3 years after intervention |
| Time Frame | 3 years |
Outcome Measure Data
| Analysis Population Description |
|---|
| Randomized patients who had at least one post-randomization visit (modified intention to treat). |
| Arm/Group Title | LAGB | Intensive Medical Diabetes & Weight Management (LAGB Grp) | RYGB | Intensive Medical Diabetes & Weight Management (RYGB Grp) |
|---|---|---|---|---|
| Arm/Group Description | Laparoscopic Adjustable Gastric Band: Allergan Adjustable Gastric Band (Device) Participants were randomized to LAGB vs. an intensive medical diabetes and weight management program (Why WAIT? Program) | Participants were randomized to LAGB vs. an intensive medical diabetes and weight management program (Why WAIT? Program) | Roux-en-Y Gastric Bypass (Surgery) Participants were randomized to RYGB vs. an intensive medical diabetes and weight management program (Why WAIT? Program) | Participants were randomized to RYGB vs. an intensive medical diabetes and weight management program (Why WAIT? Program) |
| Measure Participants | 16 | 17 | 19 | 19 |
| Mean (95% Confidence Interval) [kg/m^2] |
-3.9
|
-1.7
|
-8.7
|
-4.1
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | LAGB, Intensive Medical Diabetes & Weight Management (LAGB Grp) |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | Mixed Models Analysis | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Net) |
| Estimated Value | 2.2 | |
| Confidence Interval |
(2-Sided) 95% to |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | Estimation parameter is the difference between the change from baseline in BMI in the LAGB group vs. change from baseline in BMI in the Intensive Medical Diabetes & Weight Management (LAGB Grp), adjusted for baseline BMI. | |
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | RYGB, Intensive Medical Diabetes & Weight Management (RYGB Grp) |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | Mixed Models Analysis | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Net) |
| Estimated Value | 4.6 | |
| Confidence Interval |
(2-Sided) 95% to |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | Estimation parameter is the difference between the change from baseline in BMI in the RYGB group vs. change from baseline in BMI in the Intensive Medical Diabetes & Weight Management (RYGB Grp), adjusted for baseline BMI. | |
| Title | Cardiovascular Risk |
|---|---|
| Description | UKPDS risk of coronary heart disease, reported as change from baseline |
| Time Frame | 3 years |
Outcome Measure Data
| Analysis Population Description |
|---|
| Patients who had at least one post-randomization visit were analyzed (modified intention to treat). |
| Arm/Group Title | LAGB | Intensive Medical Diabetes & Weight Management (LAGB Grp) | RYGB | Intensive Medical Diabetes & Weight Management (RYGB Grp) |
|---|---|---|---|---|
| Arm/Group Description | Laparoscopic Adjustable Gastric Band: Allergan Adjustable Gastric Band (Device) Participants were randomized to LAGB vs. an intensive medical diabetes and weight management program (Why WAIT? Program) | Participants were randomized to LAGB vs. an intensive medical diabetes and weight management program (Why WAIT? Program) | Roux-en-Y Gastric Bypass (Surgery) Participants were randomized to RYGB vs. an intensive medical diabetes and weight management program (Why WAIT? Program) | Participants were randomized to RYGB vs. an intensive medical diabetes and weight management program (Why WAIT? Program) |
| Measure Participants | 16 | 17 | 19 | 19 |
| Mean (95% Confidence Interval) [percent likelihood of event in next 10 y] |
0.7
|
2.2
|
-2.5
|
0.1
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | LAGB, Intensive Medical Diabetes & Weight Management (LAGB Grp), RYGB, Intensive Medical Diabetes & Weight Management (RYGB Grp) |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.81 |
| Comments | ||
| Method | Mixed Models Analysis | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Net) |
| Estimated Value | 1.5 | |
| Confidence Interval |
(2-Sided) 95% to |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | Estimation parameter is the difference between change from baseline in CHD risk over 10 yrs. in LAGB group vs. change from baseline in CHD risk over 10 yrs. in Intensive Medical Diabetes & Weight Management (LAGB Grp), adjusted for baseline CHD risk. | |
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | RYGB, Intensive Medical Diabetes & Weight Management (RYGB Grp) |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.009 |
| Comments | ||
| Method | Mixed Models Analysis | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Net) |
| Estimated Value | 2.6 | |
| Confidence Interval |
(2-Sided) 95% to |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | Estimation parameter is the difference between change from baseline in CHD risk over 10 yrs. in RYGB group vs. change from baseline in CHD risk over 10 yrs. in Intensive Medical Diabetes & Weight Management (RYGB Grp), adjusted for baseline CHD risk. | |
Adverse Events
| Time Frame | 3 years | |||||||
|---|---|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | Adverse events (AE), including all-cause mortality, serious, and other adverse events were monitored in all participants, and information is included in this report. For those who were lost to followup, AE were recorded up to the timepoint of loss to followup. The total number of participants indicated is the number who completed 3 years of followup, and thus for whom AE monitoring was complete for the 3 year study. | |||||||
| Arm/Group Title | Laparoscopic Adjustable Gastric Band Surgery | Intensive Medical Diabetes and Weight Management: Band Group | Roux-en-Y Gastric Bypass (RYGB) Surgery | Intensive Medical Diabetes and Weight Management: RYGB Group | ||||
| Arm/Group Description | Surgical Implantation of Allergan Adjustable Gastric Band (Device) | |||||||
All Cause Mortality |
||||||||
| Laparoscopic Adjustable Gastric Band Surgery | Intensive Medical Diabetes and Weight Management: Band Group | Roux-en-Y Gastric Bypass (RYGB) Surgery | Intensive Medical Diabetes and Weight Management: RYGB Group | |||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/18 (0%) | 1/22 (4.5%) | 0/19 (0%) | 0/19 (0%) | ||||
Serious Adverse Events |
||||||||
| Laparoscopic Adjustable Gastric Band Surgery | Intensive Medical Diabetes and Weight Management: Band Group | Roux-en-Y Gastric Bypass (RYGB) Surgery | Intensive Medical Diabetes and Weight Management: RYGB Group | |||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 9/18 (50%) | 6/22 (27.3%) | 11/19 (57.9%) | 5/19 (26.3%) | ||||
| Cardiac disorders | ||||||||
| sudden death | 0/18 (0%) | 0 | 1/22 (4.5%) | 1 | 0/19 (0%) | 0 | 0/19 (0%) | 0 |
| coronary bypass graft or stent | 0/18 (0%) | 0 | 2/22 (9.1%) | 8 | 1/19 (5.3%) | 1 | 0/19 (0%) | 0 |
| cardiac arrest - survived | 0/18 (0%) | 0 | 0/22 (0%) | 0 | 0/19 (0%) | 0 | 1/19 (5.3%) | 1 |
| presyncope | 0/18 (0%) | 0 | 0/22 (0%) | 0 | 0/19 (0%) | 0 | 2/19 (10.5%) | 2 |
| congestive heart failure hospitalization | 0/18 (0%) | 0 | 0/22 (0%) | 0 | 0/19 (0%) | 0 | 1/19 (5.3%) | 1 |
| supraventricular arrhythmia | 0/18 (0%) | 0 | 0/22 (0%) | 0 | 0/19 (0%) | 0 | 2/19 (10.5%) | 2 |
| pulmonary embolism | 0/18 (0%) | 0 | 0/22 (0%) | 0 | 1/19 (5.3%) | 1 | 0/19 (0%) | 0 |
| Congenital, familial and genetic disorders | ||||||||
| Erb's palsy | 1/18 (5.6%) | 1 | 0/22 (0%) | 0 | 0/19 (0%) | 0 | 0/19 (0%) | 0 |
| General disorders | ||||||||
| panniculectomy | 0/18 (0%) | 0 | 0/22 (0%) | 0 | 2/19 (10.5%) | 2 | 0/19 (0%) | 0 |
| Infections and infestations | ||||||||
| cellulitis | 0/18 (0%) | 0 | 1/22 (4.5%) | 1 | 0/19 (0%) | 0 | 0/19 (0%) | 0 |
| Metabolism and nutrition disorders | ||||||||
| hospitalization for diabetes management | 1/18 (5.6%) | 1 | 0/22 (0%) | 0 | 0/19 (0%) | 0 | 0/19 (0%) | 0 |
| Musculoskeletal and connective tissue disorders | ||||||||
| orthopedic procedures | 0/18 (0%) | 0 | 1/22 (4.5%) | 1 | 2/19 (10.5%) | 2 | 1/19 (5.3%) | 1 |
| Nervous system disorders | ||||||||
| syringomyelia repair | 1/18 (5.6%) | 2 | 0/22 (0%) | 0 | 0/19 (0%) | 0 | 0/19 (0%) | 0 |
| Psychiatric disorders | ||||||||
| psychiatric hospitalizations | 0/18 (0%) | 0 | 0/22 (0%) | 0 | 2/19 (10.5%) | 2 | 0/19 (0%) | 0 |
| Renal and urinary disorders | ||||||||
| renal | 0/18 (0%) | 0 | 1/22 (4.5%) | 1 | 3/19 (15.8%) | 3 | 0/19 (0%) | 0 |
| Reproductive system and breast disorders | ||||||||
| cancer | 0/18 (0%) | 0 | 1/22 (4.5%) | 2 | 1/19 (5.3%) | 1 | 0/19 (0%) | 0 |
| Surgical and medical procedures | ||||||||
| bariatric surgery revisions and complications | 8/18 (44.4%) | 11 | 0/22 (0%) | 0 | 8/19 (42.1%) | 8 | 0/19 (0%) | 0 |
Other (Not Including Serious) Adverse Events |
||||||||
| Laparoscopic Adjustable Gastric Band Surgery | Intensive Medical Diabetes and Weight Management: Band Group | Roux-en-Y Gastric Bypass (RYGB) Surgery | Intensive Medical Diabetes and Weight Management: RYGB Group | |||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/18 (0%) | 0/22 (0%) | 0/19 (0%) | 0/19 (0%) | ||||
Limitations/Caveats
More Information
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
| Name/Title | Mary Elizabeth Patti MD |
|---|---|
| Organization | Joslin Diabetes Center |
| Phone | 617 309 1966 |
| mary.elizabeth.patti@joslin.harvard.edu |
- 2009P-001610