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Mechanisms of Diabetes Relapse After Bariatric Surgery (LAF26)

Primary Purpose

Type 2 Diabetes

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Roux-en-Y Gastric Bypass

Laparoscopic adjustable gastric banding

Vertical Sleeve Gastrectomy

About this trial

This is an interventional basic science trial for Type 2 Diabetes focused on measuring Type 2 Diabetes, Gastric Bypass, Laparoscopic Banding, Vertical Sleeve Gastrectomy

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Post GBP, LAGB or VSG Subjects

Must be able to attend 4 study visits at St. Luke's Roosevelt Hospital Center in Manhattan, New York City
History of Type 2 Diabetes before surgery

Inclusion Criteria:

35 < BMI < 50
Non-Smoker
Total Body Weight < 300 LBS
30<Age<60
HbA1c < 9%
Resting Blood Pressure < 160/100 mmHg
Beta Blockers discontinued 2 weeks prior
Fasting Triglyceride Concentration < 600 mg/dl (patient can be on dyslipidemia medications)
Without recent (within last 6 months) CHD history (prior history of angioplasty or coronary artery bypass surgery with normal stress test ok)

Exclusion Criteria:

Patients with abnormal thyroid, renal function, known malabsorption syndrome or a seizure disorder requiring anti epileptic therapy, and/or elevation of liver enzymes three times above the normal limit.
Patients should not have significant secondary complications from diabetes that would preclude undergoing gastric by-pass surgery. This would include significant psychiatric, renal or neurological, or known active coronary artery disease.
Any abnormality during the maximum exercise stress test that indicates it would be unsafe to undergo bariatric surgery.
Currently pregnant or nursing.
Known cardiovascular disease
Patient with current mucosal (gastrointestinal, respiratory, urogenital) or skin (cellulitis) infection
HbA1c >9% and diabetes diagnosed more than 6 years prior to enrollment, or patients taking insulin or TZD (Avandia, Actos, Exenatide, DPP-IV inhibitors etc.) at the time of enrollment.
Patients diagnosed with intestinal conditions such as chronic diarrhea, diverticulitis, or irritable bowel syndrome. These clinical conditions would interfere with the collection and interpretation of the H2 breath test.
Any other condition which, in the opinion of the investigators, may make the candidate unsuitable for participation in this study.

Sites / Locations

New York Obesity Nutrition Research Center, St. Luke's-Roosevelt Hospital Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Arm Label

Gastric Bypass (GBP) Subjects

Laparoscopic adjustable gastric banding (LAGB) Subjects

Vertical Sleeve Gastrectomy (VSG) Subjects

Arm Description

Subjects enrolled in the study who are receiving Roux-en-Y Gastric Bypass surgical technique for treatment of their obesity.

Subjects enrolled in the study who are receiving laparoscopic adjustable gastric banding surgical technique for treatment of their obesity.

Subjects enrolled in the study who are receiving vertical sleeve gastrectomy surgical technique for treatment of their obesity.

Outcomes

Primary Outcome Measures

Difference in insulin secretion between groups.

The investigators will assess insulin secretion in response to oral and intravenous nutrient and hormonal stimuli in the three groups.

Secondary Outcome Measures

Difference in Incretin hormone response between groups.

The investigators will assess the endogenous incretin response to oral glucose stimulus after GBP.

Difference in Body composition between groups

The investigators will assess body composition (fat mass and fat distribution) in the 3 groups.

Full Information

NCT ID

NCT01516320

First Posted

January 19, 2012

Last Updated

January 30, 2017

Sponsor

Blandine Laferrere

Collaborators

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

1. Study Identification

Unique Protocol Identification Number

NCT01516320

Brief Title

Mechanisms of Diabetes Relapse After Bariatric Surgery

Acronym

LAF26

Official Title

Mechanisms of Diabetes Relapse After Bariatric Surgery

Study Type

Interventional

2. Study Status

Record Verification Date

January 2017

Overall Recruitment Status

Completed

Study Start Date

May 13, 2009 (Actual)

Primary Completion Date

September 1, 2014 (Actual)

Study Completion Date

September 1, 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Blandine Laferrere

Collaborators

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The objective of this study is to investigate the different mechanisms by which Gastric Bypass (GBP), laparoscopic adjustable gastric banding (LAGB) and vertical sleeve gastrectomy (VSG) affect glucose control. We wish to understand the role of weight loss versus changes in gut peptides in the short and long term in morbidly obese patients with Type 2 Diabetes Mellitus after GBP, LAGB or VSG. The 2 surgical groups will be compared at 10% equivalent weight loss and at after surgery in terms of gut hormones levels, insulin secretion and glucose control.

Detailed Description

The mechanisms of type 2 diabetes (T2DM) remission after gastric bypass surgery (GBP) are unclear. The levels of the gut hormones incretins and their effect on insulin secretion, which is impaired in T2DM, markedly increase after GBP. The anatomical changes of GBP, rather than weight loss, seem to be responsible for the changes of incretins. The objective of this proposal is to investigate the different mechanisms by which GBP, laparoscopic adjustable gastric banding (LAGB) and vertical sleeve gastrectomy (VSG) affect glucose control. We wish to understand the role of weight loss versus changes in gut peptides in the short and long term in morbidly patients with T2DM after GBP, LAGB or VSG. AIM 1: Will study the short term changes of incretins levels and effect in obese individuals with T2DM after GBP, LAGB or VSG, before and 1 month after GBP or before and after equivalent weight loss after LAGB or VSG. AIM 2: Will study the long-term (12 and 24 months after surgery) changes in the incretin effect on insulin secretion, in patients with T2DM after GBP, LAGB or VSG. AIM 3: Will study the changes of insulin secretion to IV glucose (AIRg) and insulin sensitivity (Si), measured by the minimal model, in patients with T2DM after GBP, VSG or LAGB, before and at 24 months after the surgery, at weight stability under condition of controlled diet.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Type 2 Diabetes

Keywords

Type 2 Diabetes, Gastric Bypass, Laparoscopic Banding, Vertical Sleeve Gastrectomy

7. Study Design

Primary Purpose

Basic Science

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

56 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Gastric Bypass (GBP) Subjects

Arm Type

Experimental

Arm Description

Subjects enrolled in the study who are receiving Roux-en-Y Gastric Bypass surgical technique for treatment of their obesity.

Arm Title

Laparoscopic adjustable gastric banding (LAGB) Subjects

Arm Type

Active Comparator

Arm Description

Subjects enrolled in the study who are receiving laparoscopic adjustable gastric banding surgical technique for treatment of their obesity.

Arm Title

Vertical Sleeve Gastrectomy (VSG) Subjects

Arm Type

Active Comparator

Arm Description

Subjects enrolled in the study who are receiving vertical sleeve gastrectomy surgical technique for treatment of their obesity.

Intervention Type

Procedure

Intervention Name(s)

Roux-en-Y Gastric Bypass

Intervention Description

A surgical technique in which the stomach is stapled into a smaller pouch and then attached directly to the small intestine, bypassing the rest of the original stomach. The goal of the surgery is weight loss.

Intervention Type

Procedure

Intervention Name(s)

Laparoscopic adjustable gastric banding

Intervention Description

A surgical technique in which an inflatable silicone device placed around the top portion of the stomach, creating a smaller gastric pouch. The goal of the surgery is weight loss.

Intervention Type

Procedure

Intervention Name(s)

Vertical Sleeve Gastrectomy

Intervention Description

A surgical technique in which a large portion of the stomach is removed, leaving only a smaller gastric pouch. The goal of the surgery is weight loss.

Primary Outcome Measure Information:

Title

Difference in insulin secretion between groups.

Description

The investigators will assess insulin secretion in response to oral and intravenous nutrient and hormonal stimuli in the three groups.

Time Frame

0 - 48 months after surgery

Secondary Outcome Measure Information:

Title

Difference in Incretin hormone response between groups.

Description

The investigators will assess the endogenous incretin response to oral glucose stimulus after GBP.

Time Frame

0 - 48 months after surgery

Title

Difference in Body composition between groups

Description

The investigators will assess body composition (fat mass and fat distribution) in the 3 groups.

Time Frame

0 - 48 months after surgery

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Post GBP, LAGB or VSG Subjects Must be able to attend 4 study visits at St. Luke's Roosevelt Hospital Center in Manhattan, New York City History of Type 2 Diabetes before surgery Inclusion Criteria: 35 < BMI < 50 Non-Smoker Total Body Weight < 300 LBS 30<Age<60 HbA1c < 9% Resting Blood Pressure < 160/100 mmHg Beta Blockers discontinued 2 weeks prior Fasting Triglyceride Concentration < 600 mg/dl (patient can be on dyslipidemia medications) Without recent (within last 6 months) CHD history (prior history of angioplasty or coronary artery bypass surgery with normal stress test ok) Exclusion Criteria: Patients with abnormal thyroid, renal function, known malabsorption syndrome or a seizure disorder requiring anti epileptic therapy, and/or elevation of liver enzymes three times above the normal limit. Patients should not have significant secondary complications from diabetes that would preclude undergoing gastric by-pass surgery. This would include significant psychiatric, renal or neurological, or known active coronary artery disease. Any abnormality during the maximum exercise stress test that indicates it would be unsafe to undergo bariatric surgery. Currently pregnant or nursing. Known cardiovascular disease Patient with current mucosal (gastrointestinal, respiratory, urogenital) or skin (cellulitis) infection HbA1c >9% and diabetes diagnosed more than 6 years prior to enrollment, or patients taking insulin or TZD (Avandia, Actos, Exenatide, DPP-IV inhibitors etc.) at the time of enrollment. Patients diagnosed with intestinal conditions such as chronic diarrhea, diverticulitis, or irritable bowel syndrome. These clinical conditions would interfere with the collection and interpretation of the H2 breath test. Any other condition which, in the opinion of the investigators, may make the candidate unsuitable for participation in this study.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Blandine Laferrere, MD

Organizational Affiliation

New York Obesity Nutrition Research Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

New York Obesity Nutrition Research Center, St. Luke's-Roosevelt Hospital Center

City

New York

State/Province

New York

ZIP/Postal Code

10025

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Links:

URL

http://www.nyorc.org/

Description

New York Obesity Nutrition Research Center

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Mechanisms of Diabetes Relapse After Bariatric Surgery

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