The Effect of Bariatric Surgery on Metabolism, the Metabolome and Microbiome in Patients With Type 2 Diabetes
Study Details
Study Description
Brief Summary
What are the benefits of undergoing Roux-en-Y gastric bypass surgery in improving type 2 diabetes outside of weight loss alone?
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Phase 2 |
Detailed Description
Roux-en-y gastric bypass (RYGB) surgery leads to improvements in diabetes that occurs even before any significant weight loss is seen. What are the reasons for this? There is evidence in animals that changes in the composition of gut bacteria after RYGB may be responsible for improvements in how glucose is metabolized in the body. The study aims to correlate changes in the bacterial composition of the gut that occurs after surgery with improvements in glucose metabolism in people with type 2 diabetes. The investigators will do this by using validated methods to measure glucose metabolism and cutting edge technology to analyze the gut microbiome. A parallel group of patients with similar weight, height and age will undergo caloric restriction alone to mimic weight loss seen after RYGB. Participants will also undergo similar glucose metabolism studies and analysis of their gut bacterial composition. Thus, any difference seen between groups can be attributed to the surgery itself and may lead to identification of novel therapeutic options for diabetes.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Active Comparator: Roux-en-Y Gastric Bypass (RYGB) Subjects between the ages of 20-65 years of age seen for weight management in the Nutrition Clinic at Mayo Clinic, who have been approved for RYGB. |
Procedure: Roux-en-Y Gastric Bypass (RYGB)
Subjects will be studied prior to surgical intervention and 12 weeks post surgery. Subjects in surgical arm will start diet intervention after surgery. Follow up with dietary will be per standard of care following RYGB surgery.
Other Names:
|
Sham Comparator: Caloric restriction Subjects between the ages of 20-65 years of age, with diagnosis of Type 2 diabetes mellitus or impaired fasting glucose. Subjects will undergo caloric restriction alone to mimic weight loss seen after gastric bypass surgery. |
Behavioral: Caloric Restriction
Subjects participating in caloric arm of this study will be asked to consume an identical diet that is controlled for caloric content and macronutrient composition. This is identical to that consumed by patient undergoing RYGB. Subjects in the caloric restriction arm will start the diet after the screening visit. Compliance will be monitored by alternating weekly meetings with a clinical psychologist and dietician.
|
Active Comparator: Exendin-9,39 Four subjects who have undergone RYGB surgery will be studied 4 weeks after surgery. Subjects will be randomized to receive an infusion of Exendin-9,39 or normal saline. |
Drug: Exendin-9,39
A subset of 4 subjects who have undergone RYGB surgery will be studied 4 weeks after surgery. Subjects will be randomized to receive an infusion of either Exendin-9,39 or normal saline. Exendin-9,39 blocks the action of specific hormones called "incretins" that are produced by the gut in health and in larger quantities after gastric bypass surgery.
|
Placebo Comparator: Normal Saline Four subjects who have undergone RYGB surgery will be studied 4 weeks after surgery. Subjects will be randomized to receive an infusion of Exendin-9,39 or normal saline. |
Drug: Normal Saline
subset of 4 subjects who have undergone RYGB surgery will be studied 4 weeks after surgery. Subjects will be randomized to receive an infusion of either Exendin-9,39 or normal saline. Exendin-9,39 blocks the action of specific hormones called "incretins" that are produced by the gut in health and in larger quantities after gastric bypass surgery.
|
Outcome Measures
Primary Outcome Measures
- Fasting Glucose [At baseline and 12 weeks post intervention]
Blood sample taken after an overnight fast.
- Fasting Glucose [4 weeks post intervention]
Blood sample taken after an overnight fast.
- Peak Glucose [baseline and 12 weeks post intervention]
Blood sample taken after a meal.
- Peak Glucose [4 weeks post intervention]
Blood sample taken after a meal.
- Glucose AUC [0 to 360 minutes post-meal at Baseline and 12 weeks post-intervention]
Area under the curve calculated from Oral Glucose Tolerance Test
- Changes in the Gut Microbiome Following RYGB or Caloric Restriction [baseline and 12 weeks post intervention]
Stool sample collection for gut microbiome analysis
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Age 20-65 years of age.
-
Seen at Mayo Clinic Nutrition Clinic and have received authorization for RYGB surgery.
-
Type 2 Diabetes Mellitus or impaired fasting glucose with BMI >35 AND not interested in surgery but are interested in supervised caloric restriction.
Exclusion Criteria:
-
Previous treatment with thiazolidinediones.
-
Chronic antibiotic therapy.
-
Active microvascular or macrovascular complications of diabetes.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Mayo Clinic in Rochester | Rochester | Minnesota | United States | 55905 |
Sponsors and Collaborators
- Mayo Clinic
Investigators
- Principal Investigator: Meera Shah, MBChB, Mayo Clinic
Study Documents (Full-Text)
More Information
Additional Information:
Publications
None provided.- 15-000179
Study Results
Participant Flow
Recruitment Details | |
---|---|
Pre-assignment Detail | Subjects that have undergone Roux-en-Y Gastric Bypass (RYGB) and were enrolled in the RYGB arm of trial period 'Study 1-RYGB vs Caloric Restriction', will be enrolled in the second trial period 'Study 2-Exendin (9,39) Amide study' 4 weeks postoperatively. |
Arm/Group Title | Roux-en-Y Gastric Bypass (RYGB) | Caloric Restriction | Exendin-9,39 | Normal Saline |
---|---|---|---|---|
Arm/Group Description | Subjects between the ages of 20-65 years of age seen for weight management in the Nutrition Clinic at Mayo Clinic, who have been approved for RYGB. Roux-en-Y Gastric Bypass (RYGB): Subjects will be studied prior to surgical intervention and 12 weeks post surgery. Subjects in surgical arm will start diet intervention after surgery. Follow up with dietary will be per standard of care following RYGB surgery. | Subjects between the ages of 20-65 years of age, with diagnosis of Type 2 diabetes mellitus or impaired fasting glucose. Subjects will undergo caloric restriction alone to mimic weight loss seen after gastric bypass surgery. Caloric Restriction: Subjects participating in caloric arm of this study will be asked to consume an identical diet that is controlled for caloric content and macronutrient composition. This is identical to that consumed by patient undergoing RYGB. Subjects in the caloric restriction arm will start the diet after the screening visit. Compliance will be monitored by alternating weekly meetings with a clinical psychologist and dietician. | Four subjects who have undergone RYGB surgery will be studied 4 weeks after surgery. Subjects will be randomized to receive an infusion of Exendin-9,39 or normal saline. Exendin-9,39: A subset of 4 subjects who have undergone RYGB surgery will be studied 4 weeks after surgery. Subjects will be randomized to receive an infusion of either Exendin-9,39 or normal saline. Exendin-9,39 blocks the action of specific hormones called "incretins" that are produced by the gut in health and in larger quantities after gastric bypass surgery. | Four subjects who have undergone RYGB surgery will be studied 4 weeks after surgery. Subjects will be randomized to receive an infusion of Exendin-9,39 or normal saline. Normal Saline: subset of 4 subjects who have undergone RYGB surgery will be studied 4 weeks after surgery. Subjects will be randomized to receive an infusion of either Exendin-9,39 or normal saline. Exendin-9,39 blocks the action of specific hormones called "incretins" that are produced by the gut in health and in larger quantities after gastric bypass surgery. |
Period Title: Study 1 - RYGB vs Caloric Restriction | ||||
STARTED | 3 | 9 | 0 | 0 |
COMPLETED | 3 | 7 | 0 | 0 |
NOT COMPLETED | 0 | 2 | 0 | 0 |
Period Title: Study 1 - RYGB vs Caloric Restriction | ||||
STARTED | 0 | 0 | 1 | 0 |
COMPLETED | 0 | 0 | 1 | 0 |
NOT COMPLETED | 0 | 0 | 0 | 0 |
Baseline Characteristics
Arm/Group Title | Roux-en-Y Gastric Bypass (RYGB) | Caloric Restriction | Exendin-9,39 | Normal Saline | Total |
---|---|---|---|---|---|
Arm/Group Description | Subjects between the ages of 20-65 years of age seen for weight management in the Nutrition Clinic at Mayo Clinic, who have been approved for RYGB. Roux-en-Y Gastric Bypass (RYGB): Subjects will be studied prior to surgical intervention and 12 weeks post surgery. Subjects in surgical arm will start diet intervention after surgery. Follow up with dietary will be per standard of care following RYGB surgery. | Subjects between the ages of 20-65 years of age, with diagnosis of Type 2 diabetes mellitus or impaired fasting glucose. Subjects will undergo caloric restriction alone to mimic weight loss seen after gastric bypass surgery. Caloric Restriction: Subjects participating in caloric arm of this study will be asked to consume an identical diet that is controlled for caloric content and macronutrient composition. This is identical to that consumed by patient undergoing RYGB. Subjects in the caloric restriction arm will start the diet after the screening visit. Compliance will be monitored by alternating weekly meetings with a clinical psychologist and dietician. | Four subjects who have undergone RYGB surgery will be studied 4 weeks after surgery. Subjects will be randomized to receive an infusion of Exendin-9,39 or normal saline. Exendin-9,39: A subset of 4 subjects who have undergone RYGB surgery will be studied 4 weeks after surgery. Subjects will be randomized to receive an infusion of either Exendin-9,39 or normal saline. Exendin-9,39 blocks the action of specific hormones called "incretins" that are produced by the gut in health and in larger quantities after gastric bypass surgery. | Four subjects who have undergone RYGB surgery will be studied 4 weeks after surgery. Subjects will be randomized to receive an infusion of Exendin-9,39 or normal saline. Normal Saline: subset of 4 subjects who have undergone RYGB surgery will be studied 4 weeks after surgery. Subjects will be randomized to receive an infusion of either Exendin-9,39 or normal saline. Exendin-9,39 blocks the action of specific hormones called "incretins" that are produced by the gut in health and in larger quantities after gastric bypass surgery. | Total of all reporting groups |
Overall Participants | 3 | 9 | 1 | 0 | 13 |
Age (Count of Participants) | |||||
<=18 years |
0
0%
|
0
0%
|
0
0%
|
||
Between 18 and 65 years |
3
100%
|
9
100%
|
12
1200%
|
||
>=65 years |
0
0%
|
0
0%
|
0
0%
|
||
<=18 years |
0
0%
|
0
0%
|
|||
Between 18 and 65 years |
1
33.3%
|
1
11.1%
|
|||
>=65 years |
0
0%
|
0
0%
|
|||
Sex: Female, Male (Count of Participants) | |||||
Female |
2
66.7%
|
6
66.7%
|
0
0%
|
8
Infinity
|
|
Male |
1
33.3%
|
3
33.3%
|
0
0%
|
4
Infinity
|
|
Female |
1
33.3%
|
1
11.1%
|
|||
Male |
0
0%
|
0
0%
|
|||
Ethnicity (NIH/OMB) (Count of Participants) | |||||
Hispanic or Latino |
0
0%
|
0
0%
|
0
0%
|
0
NaN
|
|
Not Hispanic or Latino |
1
33.3%
|
0
0%
|
0
0%
|
1
Infinity
|
|
Unknown or Not Reported |
2
66.7%
|
9
100%
|
0
0%
|
11
Infinity
|
|
Hispanic or Latino |
0
0%
|
0
0%
|
|||
Not Hispanic or Latino |
1
33.3%
|
1
11.1%
|
|||
Unknown or Not Reported |
0
0%
|
0
0%
|
|||
Race (NIH/OMB) (Count of Participants) | |||||
American Indian or Alaska Native |
0
0%
|
0
0%
|
0
0%
|
||
Asian |
0
0%
|
0
0%
|
0
0%
|
||
Native Hawaiian or Other Pacific Islander |
0
0%
|
0
0%
|
0
0%
|
||
Black or African American |
0
0%
|
0
0%
|
0
0%
|
||
White |
3
100%
|
9
100%
|
12
1200%
|
||
More than one race |
0
0%
|
0
0%
|
0
0%
|
||
Unknown or Not Reported |
0
0%
|
0
0%
|
0
0%
|
||
American Indian or Alaska Native |
0
0%
|
0
0%
|
|||
Asian |
0
0%
|
0
0%
|
|||
Native Hawaiian or Other Pacific Islander |
0
0%
|
0
0%
|
|||
Black or African American |
0
0%
|
0
0%
|
|||
White |
1
33.3%
|
1
11.1%
|
|||
More than one race |
0
0%
|
0
0%
|
|||
Unknown or Not Reported |
0
0%
|
0
0%
|
|||
Region of Enrollment (participants) [Number] | |||||
United States |
3
100%
|
9
100%
|
12
1200%
|
||
Region of Enrollment (participants) [Number] | |||||
United States |
1
33.3%
|
1
11.1%
|
Outcome Measures
Title | Fasting Glucose |
---|---|
Description | Blood sample taken after an overnight fast. |
Time Frame | At baseline and 12 weeks post intervention |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title | Roux-en-Y Gastric Bypass (RYGB) | Caloric Restriction |
---|---|---|
Arm/Group Description | Subjects between the ages of 20-65 years of age seen for weight management in the Nutrition Clinic at Mayo Clinic, who have been approved for RYGB. Roux-en-Y Gastric Bypass (RYGB): Subjects will be studied prior to surgical intervention and 12 weeks post surgery. Subjects in surgical arm will start diet intervention after surgery. Follow up with dietary will be per standard of care following RYGB surgery. | Subjects between the ages of 20-65 years of age, with diagnosis of Type 2 diabetes mellitus or impaired fasting glucose. Subjects will undergo caloric restriction alone to mimic weight loss seen after gastric bypass surgery. Caloric Restriction: Subjects participating in caloric arm of this study will be asked to consume an identical diet that is controlled for caloric content and macronutrient composition. This is identical to that consumed by patient undergoing RYGB. Subjects in the caloric restriction arm will start the diet after the screening visit. Compliance will be monitored by alternating weekly meetings with a clinical psychologist and dietician. |
Measure Participants | 3 | 7 |
Baseline |
6.1
(0.88)
|
7.23
(0.98)
|
12 weeks post intervention |
6.48
(1.7)
|
5.89
(0.4)
|
Title | Fasting Glucose |
---|---|
Description | Blood sample taken after an overnight fast. |
Time Frame | 4 weeks post intervention |
Outcome Measure Data
Analysis Population Description |
---|
The number of participants analyzed for the Normal Saline group at 4 weeks post intervention is zero because no subjects were enrolled in this arm. |
Arm/Group Title | Exendin-9,39 | Normal Saline |
---|---|---|
Arm/Group Description | Four subjects who have undergone RYGB surgery will be studied 4 weeks after surgery. Subjects will be randomized to receive an infusion of Exendin-9,39 or normal saline. Exendin-9,39: A subset of 4 subjects who have undergone RYGB surgery will be studied 4 weeks after surgery. Subjects will be randomized to receive an infusion of either Exendin-9,39 or normal saline. Exendin-9,39 blocks the action of specific hormones called "incretins" that are produced by the gut in health and in larger quantities after gastric bypass surgery. | Four subjects who have undergone RYGB surgery will be studied 4 weeks after surgery. Subjects will be randomized to receive an infusion of Exendin-9,39 or normal saline. Normal Saline: subset of 4 subjects who have undergone RYGB surgery will be studied 4 weeks after surgery. Subjects will be randomized to receive an infusion of either Exendin-9,39 or normal saline. Exendin-9,39 blocks the action of specific hormones called "incretins" that are produced by the gut in health and in larger quantities after gastric bypass surgery. |
Measure Participants | 1 | 0 |
Number [mmol/l] |
4.75
|
Title | Peak Glucose |
---|---|
Description | Blood sample taken after a meal. |
Time Frame | baseline and 12 weeks post intervention |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title | Roux-en-Y Gastric Bypass (RYGB) | Caloric Restriction |
---|---|---|
Arm/Group Description | Subjects between the ages of 20-65 years of age seen for weight management in the Nutrition Clinic at Mayo Clinic, who have been approved for RYGB. Roux-en-Y Gastric Bypass (RYGB): Subjects will be studied prior to surgical intervention and 12 weeks post surgery. Subjects in surgical arm will start diet intervention after surgery. Follow up with dietary will be per standard of care following RYGB surgery. | Subjects between the ages of 20-65 years of age, with diagnosis of Type 2 diabetes mellitus or impaired fasting glucose. Subjects will undergo caloric restriction alone to mimic weight loss seen after gastric bypass surgery. Caloric Restriction: Subjects participating in caloric arm of this study will be asked to consume an identical diet that is controlled for caloric content and macronutrient composition. This is identical to that consumed by patient undergoing RYGB. Subjects in the caloric restriction arm will start the diet after the screening visit. Compliance will be monitored by alternating weekly meetings with a clinical psychologist and dietician. |
Measure Participants | 3 | 7 |
Baseline |
11.35
(1.5)
|
10.84
(1.39)
|
12 weeks post intervention |
11.8
(3.25)
|
10.04
(0.54)
|
Title | Peak Glucose |
---|---|
Description | Blood sample taken after a meal. |
Time Frame | 4 weeks post intervention |
Outcome Measure Data
Analysis Population Description |
---|
The number of participants analyzed for the Normal Saline group at 4 weeks post intervention is zero because no subjects were enrolled in this arm. |
Arm/Group Title | Exendin-9,39 | Normal Saline |
---|---|---|
Arm/Group Description | Four subjects who have undergone RYGB surgery will be studied 4 weeks after surgery. Subjects will be randomized to receive an infusion of Exendin-9,39 or normal saline. Exendin-9,39: A subset of 4 subjects who have undergone RYGB surgery will be studied 4 weeks after surgery. Subjects will be randomized to receive an infusion of either Exendin-9,39 or normal saline. Exendin-9,39 blocks the action of specific hormones called "incretins" that are produced by the gut in health and in larger quantities after gastric bypass surgery. | Four subjects who have undergone RYGB surgery will be studied 4 weeks after surgery. Subjects will be randomized to receive an infusion of Exendin-9,39 or normal saline. Normal Saline: subset of 4 subjects who have undergone RYGB surgery will be studied 4 weeks after surgery. Subjects will be randomized to receive an infusion of either Exendin-9,39 or normal saline. Exendin-9,39 blocks the action of specific hormones called "incretins" that are produced by the gut in health and in larger quantities after gastric bypass surgery. |
Measure Participants | 1 | 0 |
Number [mmol/l] |
8.15
|
Title | Glucose AUC |
---|---|
Description | Area under the curve calculated from Oral Glucose Tolerance Test |
Time Frame | 0 to 360 minutes post-meal at Baseline and 12 weeks post-intervention |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title | Roux-en-Y Gastric Bypass (RYGB) | Caloric Restriction |
---|---|---|
Arm/Group Description | Subjects between the ages of 20-65 years of age seen for weight management in the Nutrition Clinic at Mayo Clinic, who have been approved for RYGB. Roux-en-Y Gastric Bypass (RYGB): Subjects will be studied prior to surgical intervention and 12 weeks post surgery. Subjects in surgical arm will start diet intervention after surgery. Follow up with dietary will be per standard of care following RYGB surgery. | Subjects between the ages of 20-65 years of age, with diagnosis of Type 2 diabetes mellitus or impaired fasting glucose. Subjects will undergo caloric restriction alone to mimic weight loss seen after gastric bypass surgery. Caloric Restriction: Subjects participating in caloric arm of this study will be asked to consume an identical diet that is controlled for caloric content and macronutrient composition. This is identical to that consumed by patient undergoing RYGB. Subjects in the caloric restriction arm will start the diet after the screening visit. Compliance will be monitored by alternating weekly meetings with a clinical psychologist and dietician. |
Measure Participants | 3 | 7 |
Baseline |
2815
(223)
|
2715
(375)
|
12 weeks post intervention |
3146
(1186)
|
2380
(139)
|
Title | Changes in the Gut Microbiome Following RYGB or Caloric Restriction |
---|---|
Description | Stool sample collection for gut microbiome analysis |
Time Frame | baseline and 12 weeks post intervention |
Outcome Measure Data
Analysis Population Description |
---|
No participants samples were analyzed due to inability to obtain funding to proceed with gut microbiome analysis. |
Arm/Group Title | Roux-en-Y Gastric Bypass (RYGB) | Caloric Restriction |
---|---|---|
Arm/Group Description | Subjects between the ages of 20-65 years of age seen for weight management in the Nutrition Clinic at Mayo Clinic, who have been approved for RYGB. Roux-en-Y Gastric Bypass (RYGB): Subjects will be studied prior to surgical intervention and 12 weeks post surgery. Subjects in surgical arm will start diet intervention after surgery. Follow up with dietary will be per standard of care following RYGB surgery. | Subjects between the ages of 20-65 years of age, with diagnosis of Type 2 diabetes mellitus or impaired fasting glucose. Subjects will undergo caloric restriction alone to mimic weight loss seen after gastric bypass surgery. Caloric Restriction: Subjects participating in caloric arm of this study will be asked to consume an identical diet that is controlled for caloric content and macronutrient composition. This is identical to that consumed by patient undergoing RYGB. Subjects in the caloric restriction arm will start the diet after the screening visit. Compliance will be monitored by alternating weekly meetings with a clinical psychologist and dietician. |
Measure Participants | 0 | 0 |
Adverse Events
Time Frame | Adverse events were collected from baseline to end of study participation for a total of approximately 12 weeks on all participants. | |||||||
---|---|---|---|---|---|---|---|---|
Adverse Event Reporting Description | Number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other (Not Including Serious) Adverse Events is zero for the saline arm because no participants were enrolled in the saline arm of study 2- Exendin (9,39) Amide study period. | |||||||
Arm/Group Title | Roux-en-Y Gastric Bypass (RYGB) | Caloric Restriction | Exendin-9,39 | Normal Saline | ||||
Arm/Group Description | Subjects between the ages of 20-65 years of age seen for weight management in the Nutrition Clinic at Mayo Clinic, who have been approved for RYGB. Roux-en-Y Gastric Bypass (RYGB): Subjects will be studied prior to surgical intervention and 12 weeks post surgery. Subjects in surgical arm will start diet intervention after surgery. Follow up with dietary will be per standard of care following RYGB surgery. | Subjects between the ages of 20-65 years of age, with diagnosis of Type 2 diabetes mellitus or impaired fasting glucose. Subjects will undergo caloric restriction alone to mimic weight loss seen after gastric bypass surgery. Caloric Restriction: Subjects participating in caloric arm of this study will be asked to consume an identical diet that is controlled for caloric content and macronutrient composition. This is identical to that consumed by patient undergoing RYGB. Subjects in the caloric restriction arm will start the diet after the screening visit. Compliance will be monitored by alternating weekly meetings with a clinical psychologist and dietician. | Four subjects who have undergone RYGB surgery will be studied 4 weeks after surgery. Subjects will be randomized to receive an infusion of Exendin-9,39 or normal saline. Exendin-9,39: A subset of 4 subjects who have undergone RYGB surgery will be studied 4 weeks after surgery. Subjects will be randomized to receive an infusion of either Exendin-9,39 or normal saline. Exendin-9,39 blocks the action of specific hormones called "incretins" that are produced by the gut in health and in larger quantities after gastric bypass surgery. | Four subjects who have undergone RYGB surgery will be studied 4 weeks after surgery. Subjects will be randomized to receive an infusion of Exendin-9,39 or normal saline. Normal Saline: subset of 4 subjects who have undergone RYGB surgery will be studied 4 weeks after surgery. Subjects will be randomized to receive an infusion of either Exendin-9,39 or normal saline. Exendin-9,39 blocks the action of specific hormones called "incretins" that are produced by the gut in health and in larger quantities after gastric bypass surgery. | ||||
All Cause Mortality |
||||||||
Roux-en-Y Gastric Bypass (RYGB) | Caloric Restriction | Exendin-9,39 | Normal Saline | |||||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 0/3 (0%) | 0/9 (0%) | 0/1 (0%) | 0/0 (NaN) | ||||
Serious Adverse Events |
||||||||
Roux-en-Y Gastric Bypass (RYGB) | Caloric Restriction | Exendin-9,39 | Normal Saline | |||||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 0/3 (0%) | 0/9 (0%) | 0/1 (0%) | 0/0 (NaN) | ||||
Other (Not Including Serious) Adverse Events |
||||||||
Roux-en-Y Gastric Bypass (RYGB) | Caloric Restriction | Exendin-9,39 | Normal Saline | |||||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 0/3 (0%) | 0/9 (0%) | 0/1 (0%) | 0/0 (NaN) |
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 | Meera Shah, MB, ChB |
---|---|
Organization | Mayo Clinic |
Phone | 507-284-0106 |
Shah.Meera@mayo.edu |
- 15-000179