Comparison Between Pyloric Preserving and Non-Pyloric Preserving Bariatric Surgery With Glucose Challenge

• Sponsor: Medtronic - MITG (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00998374
• Collaborator: (none)
• Enrollment: 62
• Location: 1
• Duration (Months): 43
• Patients Per Site Per Month: 1.4

Study Details

Study Description

Brief Summary

This study will compare glucose and simple carbohydrate sensitivity. The hypothesis is that rapid emptying of high-glycemic index foods after Roux-En-Y gastric bypass (RYGB) causes reactive hypoglycemia. It is believed that the controlled release offered by an intact pylorus will be advantageous for long term results in bariatric surgery. This study can provide a scientific rationale, in a short duration of time, for why pylorus sparing surgery, such as the sleeve gastrectomy or duodenal switch, may offer therapeutic advantages, as compared to non-pyloric sparing surgery, namely the gastric bypass.

Condition or Disease	Intervention/Treatment	Phase
Hypoglycemia; Obesity

Detailed Description

Clinical Trial Objective:

The objective of this clinical trial is to determine whether an intact pylorus prevents reactive hypoglycemia following challenge with liquid glucose preparation and/or solid load made of refined flour product that is a simple carbohydrate.

Clinical Trial Design:

This is a prospective, non-randomized, clinical trial.

Study Design

• Study Type: Observational
• Actual Enrollment: 62 participants
• Observational Model: Case-Only
• Time Perspective: Prospective
• Official Title: Comparison Between Pyloric Preserving and Non-Pyloric Preserving Bariatric Surgery With Glucose Challenge
• Study Start Date: Sep 1, 2009
• Actual Primary Completion Date: Jan 1, 2013
• Actual Study Completion Date: Apr 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Pyloric-sparing vs. non-pyloric sparing Pyloric: SG & DS Non-pyloric: RYGB

Outcome Measures

Primary Outcome Measures

1. Mean Serum Glucose Levels [30, 60, and 120 minutes at 6, 9, and 12 months post-operatively]

   Serum glucose levels measured to assess reactive hypoglycemia status

2. Reactive Hypoglycemia Status [6 months, 9 months, 12 months post-op]

   Postoperative reactive hypoglycemia was defined as either serum glucose <60 mg/dL at least 1 hour after initiation of glucose tolerance testing serum glucose decrease ≥100 mg/dL within 1 hour after initiation of glucose tolerance testing

Secondary Outcome Measures

1. Insulin Resistance [6, 9, and 12 months post-operatively]

   Measured by levels of post prandial insulin

2. Subjective Symptoms of Hypoglycemia During Glucose Tolerance Testing [6, 9, and 12 months post-op]

   Subjective symptoms of hypoglycemia during glucose tolerance testing measured by patients' responses to a questionnaire about symptoms of Weakness, Nausea, Hunger, Headache, Dizziness, Diaphoresis graded on a yes/no response

Eligibility Criteria

Criteria

• Ages Eligible for Study: 19 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• The patient is greater than 18 years old;

• The patient has a BMI > 35;

• Patient meets standards for bariatric surgery;

Exclusion Criteria:

• The patient has an incurable malignant or debilitating disease;

• The patient has been diagnosed with a severe eating disorder;

• The patient is currently pregnant (pregnancy test required for confirmation for those of child bearing years);

• The patient is unable to comply with the study requirements, follow-up schedule, or to give valid informed consent

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Lenox Hill Hospital 186 E76th Street, 1st Floor	New York City	New York	United States	10021

Sponsors and Collaborators

• Medtronic - MITG

Investigators

• Principal Investigator: Mitchell Roslin, MD, Lenox Hill Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Medtronic - MITG
• ClinicalTrials.gov Identifier: NCT00998374
• Other Study ID Numbers: AS08018
• First Posted: Oct 20, 2009
• Last Update Posted: Apr 21, 2014
• Last Verified: Mar 1, 2014

• Additional relevant MeSH terms: Hypoglycemia

Study Results

Participant Flow

Arm/Group Title	Pyloric-sparing	Non-pyloric Sparing
Arm/Group Description	Pyloric: Sleeve Gastrectomy (SG) & Duodenal Switch (DS)	Non-pyloric sparing: Roux-en-Y Gastric Bypass (RYGB)
Period Title: Overall Study
STARTED	39	23
COMPLETED	27	12
NOT COMPLETED	12	11

Baseline Characteristics

Arm/Group Title	Pyloric-sparing	Non-pyloric Sparing	Total
Arm/Group Description	Pyloric sparing: Sleeve Gastrectomy and Duodenal Switch	Non-pyloric sparing: Roux-en-Y Gastric Bypass	Total of all reporting groups
Overall Participants	39	23	62
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	39 100%	23 100%	62 100%
>=65 years	0 0%	0 0%	0 0%
Sex: Female, Male (Count of Participants)
Female	24 61.5%	20 87%	44 71%
Male	15 38.5%	3 13%	18 29%
Region of Enrollment (participants) [Number]
United States	39 100%	23 100%	62 100%

Outcome Measures

1. Primary Outcome

Title	Mean Serum Glucose Levels
Description	Serum glucose levels measured to assess reactive hypoglycemia status
Time Frame	30, 60, and 120 minutes at 6, 9, and 12 months post-operatively

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Pyloric-sparing	Non-pyloric Sparing
Arm/Group Description	Pyloric: SG & DS	Non-pyloric sparing: RYGB
Measure Participants	39	23
6 months - 30 minutes	123.1 (48.8)	157.5 (56.2)
9 months - 30 minutes	103.2 (30.2)	138 (50.1)
12 months - 30 minutes	130.3 (49.6)	173.4 (78.3)
6 months - 60 minutes	121.8 (65.6)	152.6 (79.6)
9 months - 60 minutes	98.8 (34.9)	132.6 (65.2)
12 months - 60 minutes	121.1 (52.3)	141.8 (90.7)
6 months - 120 minutes	83.4 (48.4)	83.4 (45.9)
9 months - 120 minutes	88.3 (33.1)	85.3 (41.3)
12 months - 120 minutes	84.5 (52.1)	79.5 (58.6)

2. Secondary Outcome

Title	Insulin Resistance
Description	Measured by levels of post prandial insulin
Time Frame	6, 9, and 12 months post-operatively

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Pyloric-sparing	Non-pyloric Sparing
Arm/Group Description	Pyloric: SG & DS	Non-pyloric: RYGB
Measure Participants	39	23
1 hour pp - 6 month	13.7 (11.7)	21.2 (16.4)
1 hour pp - 9 month	6.4 (3.2)	20.9 (25.1)
1 hour pp - 12 month	10.9 (9.3)	16.7 (14.6)
2 hours pp - 6 month	3.8 (2.5)	3.9 (6.7)
2 hours pp - 9 month	2.6 (2.3)	4.2 (4.9)
2 hours pp - 12 month	4.8 (12.4)	6.6 (12.3)

3. Secondary Outcome

Title	Subjective Symptoms of Hypoglycemia During Glucose Tolerance Testing
Description	Subjective symptoms of hypoglycemia during glucose tolerance testing measured by patients' responses to a questionnaire about symptoms of Weakness, Nausea, Hunger, Headache, Dizziness, Diaphoresis graded on a yes/no response
Time Frame	6, 9, and 12 months post-op

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Pyloric-sparing	Non-pyloric
Arm/Group Description	Pyloric: SG & DS	Non-pyloric: RYGB
Measure Participants	39	23
6 Month - Weakness	6 15.4%	8 34.8%
9 Month - Weakness	1 2.6%	3 13%
12 Month - Weakness	2 5.1%	6 26.1%
6 Month - Nausea	12 30.8%	8 34.8%
9 Month - Nausea	2 5.1%	6 26.1%
12 Month - Nausea	5 12.8%	6 26.1%
6 Month - Hunger	4 10.3%	3 13%
9 Month - Hunger	0 0%	2 8.7%
12 Month - Hunger	2 5.1%	1 4.3%
6 Month - Headache	4 10.3%	3 13%
9 Month - Headache	3 7.7%	3 13%
12 Month - Headache	4 10.3%	3 13%
6 Month - Dizziness	10 25.6%	7 30.4%
9 Month - Dizziness	1 2.6%	4 17.4%
12 Month - Dizziness	0 0%	3 13%
6 Month - Sweating	4 10.3%	2 8.7%
9 Month - Sweating	0 0%	2 8.7%
12 Month - Sweating	0 0%	2 8.7%

4. Primary Outcome

Title	Reactive Hypoglycemia Status
Description	Postoperative reactive hypoglycemia was defined as either serum glucose <60 mg/dL at least 1 hour after initiation of glucose tolerance testing serum glucose decrease ≥100 mg/dL within 1 hour after initiation of glucose tolerance testing
Time Frame	6 months, 9 months, 12 months post-op

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Pyloric-sparing	Non-pyloric Sparing
Arm/Group Description	Pyloric: SG & DS	Non-pyloric: RYGB
Measure Participants	39	23
6 Month	11 28.2%	6 26.1%
9 Month	4 10.3%	3 13%
12 Month	7 17.9%	7 30.4%

Adverse Events

Time Frame	Day 0, 2 weeks, 4 weeks, 3 months, 6 months, 9 months, 12 months
Adverse Event Reporting Description	During each visit study subjects were asked whether an adverse event had occurred, and their 'yes'/'no'responses were recorded on the corresponding visit CRFs.
Arm/Group Title	Pyloric-sparing		Non-pyloric Sparing
Arm/Group Description	Pyloric: SG & DS		Non-pyloric: RYGB
All Cause Mortality
	Pyloric-sparing		Non-pyloric Sparing
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Pyloric-sparing		Non-pyloric Sparing
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	5/39 (12.8%)		3/23 (13%)
Blood and lymphatic system disorders
Hypoalbuminemia	1/39 (2.6%)	1	0/23 (0%)	0
Gastrointestinal disorders
Colitis	1/39 (2.6%)	1	0/23 (0%)	0
Enterocutaneous fistula	0/39 (0%)	0	1/23 (4.3%)	1
General disorders
Lower Left Quadrant (LLQ) pain	1/39 (2.6%)	1	0/23 (0%)	0
Epigastric hernia	1/39 (2.6%)	1	0/23 (0%)	0
Infections and infestations
Wound infection	0/39 (0%)	0	1/23 (4.3%)	1
Respiratory, thoracic and mediastinal disorders
Atelectasis	0/39 (0%)	0	1/23 (4.3%)	1
Surgical and medical procedures
Anastamotic Leak	1/39 (2.6%)	1	0/23 (0%)	0
Bleeding	0/39 (0%)	0	1/23 (4.3%)	1
Vascular disorders
DVT/PE	1/39 (2.6%)	1	0/23 (0%)	0
Portal and superior mesenteric venous thrombosis	1/39 (2.6%)	1	0/23 (0%)	0
Other (Not Including Serious) Adverse Events
	Pyloric-sparing		Non-pyloric Sparing
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	8/39 (20.5%)		2/23 (8.7%)
Cardiac disorders
Sinus tachycardia	1/39 (2.6%)	1	0/23 (0%)	0
SVT	1/39 (2.6%)	1	0/23 (0%)	0
Gastrointestinal disorders
GERD	1/39 (2.6%)	1	0/23 (0%)	0
General disorders
Fever	1/39 (2.6%)	1	0/23 (0%)	0
Hypovolemia	1/39 (2.6%)	1	0/23 (0%)	0
Hypoxic	2/39 (5.1%)	2	0/23 (0%)	0
Fatigue	1/39 (2.6%)	1	0/23 (0%)	0
Left Kidney Stone (left flank pain)	1/39 (2.6%)	1	0/23 (0%)	0
more than expected post-op pain	1/39 (2.6%)	1	0/23 (0%)	0
Nocturnal desaturation	1/39 (2.6%)	1	0/23 (0%)	0
Mild tingling of the legs	1/39 (2.6%)	1	0/23 (0%)	0
Severe vomiting	0/39 (0%)	0	1/23 (4.3%)	1
Psychiatric disorders
Anxiety	1/39 (2.6%)	1	0/23 (0%)	0
Surgical and medical procedures
Anastomotic stricture	1/39 (2.6%)	1	0/23 (0%)	0
Incomplete staple line	0/39 (0%)	0	1/23 (4.3%)	1

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT 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.