Changes in Insulin Sensitivity After Weight Loss

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

119 participants

Study Classification

OBSERVATIONAL

Study Start Date

2005-03-01

Study Completion Date

2018-06-17

Brief Summary

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This study is designed to compare the changes in insulin sensitivity as well as gastrointestinal hormone levels in diabetic and non-diabetic obese individuals who are undergoing weight loss procedures. The main hypothesis of this study is that weight loss induced by gastric bypass will induce a greater improvement in insulin sensitivity compared with gastric banding or low calorie diet. Subjects will be studied before and after weight loss. Studies consist of intravenous glucose tolerance test, body composition analysis, meal test, and energy expenditure.

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Detailed Description

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Patients who are scheduled for gastric bypass (GBP), sleeve gastrectomy (SG), or simple caloric restriction with gastric banding (BND) or a very low calorie diet (VLCD) will be examined at baseline weight, and when 6-10% total body weight has been lost. We will measure insulin sensitivity with an intravenous glucose tolerance test, and fasting levels of hormones that regulate food intake and insulin sensitivity, such as ghrelin, peptide YY (PYY), glucagon-like peptide 1 (GLP1) and leptin. Fat mass and skeletal muscle mass will be measured by dual photon absorptiometry (DXA). We will also measure the hormonal and thermic response to food with a liquid test meal and energy expenditure by indirect calorimetry. This measures how many calories are burned at rest and the in response to food. Subjects with diabetes will continue to be studied with the same protocol on an annual basis out to 5 years in order to determine the rate of remission of diabetes and the durability of this effect as subjects tend to regain some body weight over time.

Subjects with diabetes will also be followed every three months for the first year after the initial weight loss for HbA1c and fasting glucose levels. The results of this study may lead to new understanding about changes in insulin sensitivity, body composition and hormonal profile, as well as changes in energy expenditure with weight loss after bariatric surgery or with simple caloric restriction. With this greater understanding, new treatments for obesity and diabetes, that do not require surgery, may be developed.

Conditions

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Obesity Type 2 Diabetes Mellitus Insulin Resistance

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Group 1: GBP non-diabetic

Non-diabetic subjects scheduled to receive gastric bypass

Gastric bypass

Intervention Type PROCEDURE

NOTE: the surgery is not paid for by the study

Group 2: BND non-diabetic

Non-diabetic subjects scheduled to receive gastric banding

Gastric banding

Intervention Type PROCEDURE

NOTE: the surgery is not paid for by the study

Group 3: GBP diabetic

Diabetic subjects scheduled to receive gastric bypass

Gastric bypass

Intervention Type PROCEDURE

NOTE: the surgery is not paid for by the study

Group 4: VLCD diabetic

Diabetic subjects scheduled to receive very low calorie diet

Very low calorie diet

Intervention Type BEHAVIORAL

Weight loss with calorie restricted liquid diet. Subject will be asked to stay in our in-patient research unit for 2-3 weeks and consume only those foods supplied by our bionutrition unit. Expected weight loss should be between 7-10% of body weight. Subjects will receive the diet at no cost and will be compensated for their time.

Group 5: SG diabetic

Diabetic subjects scheduled to receive sleeve gastrectomy

Sleeve gastrectomy

Intervention Type PROCEDURE

NOTE: the surgery is not paid for by the study

Interventions

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Gastric bypass

NOTE: the surgery is not paid for by the study

Intervention Type PROCEDURE

Gastric banding

NOTE: the surgery is not paid for by the study

Intervention Type PROCEDURE

Sleeve gastrectomy

NOTE: the surgery is not paid for by the study

Intervention Type PROCEDURE

Very low calorie diet

Weight loss with calorie restricted liquid diet. Subject will be asked to stay in our in-patient research unit for 2-3 weeks and consume only those foods supplied by our bionutrition unit. Expected weight loss should be between 7-10% of body weight. Subjects will receive the diet at no cost and will be compensated for their time.

Intervention Type BEHAVIORAL

Other Intervention Names

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GBP BND SG VLCD

Eligibility Criteria

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Inclusion Criteria

* Non-diabetic obese (BMI \> 30) adult men and women between the ages of 18 and 75 scheduled to undergo

* gastric bypass (GBP)
* gastric banding (BND)
* Type 2 diabetes (HbA1c 6-12%) adult men and women between the ages of 18 and 75 scheduled to undergo gastric bypass.
* Type 2 diabetes (HbA1c 6-12%) adult men and women between the ages of 18 and 65 for weight reduction with a very low caloric diet (VLCD).
* Type 2 diabetes mellitus scheduled to undergo sleeve gastrectomy (SG).

Exclusion Criteria

* Pregnancy.
* Age \> 75 for surgery groups; Age \> 65 for VLCD group.
* Treatment with glucocorticoids, anti-depressants, anti-psychotics, neuroleptics, weight loss medications, experimental medication.
* Greater than a 5% change in total body weight in the 90 days prior to the study.
* History of untreated gallstones; hepatic or renal insufficiency, abnormal thyroid stimulating hormone (TSH).
* Use of thiazolidinedione therapy.
* HbA1c \> 12%.
* Use of dipeptidyl peptidase IV (DPP-IV) inhibitor or glucagon-like peptide 1 receptor (GLP-1R) agonist for greater than 12 months within 3 months of the study.
* Fasting triglycerides \> 400.
* Significant cardiovascular, neurologic, renal, gastrointestinal, or hematologic disease.
* Inability to comply with or understand the study protocol as ascertained by the PI.
* We will not exclude individuals with body weight \> 145 kg, but we do recognize that such individuals are above the table weight limitations of the dual-energy x-ray absorptiometry (DEXA) scan and body composition data will be unavailable for those individuals.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes