Changes in Insulin Sensitivity After Weight Loss

Completed

Conditions studied: Obesity, Type 2 Diabetes Mellitus, Insulin Resistance

In brief

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.

Key facts

Study ID

NCT00627484

Run by

Columbia University

People needed

119

Starts

2005-03-01

Expected to finish

2018-06-17

Last updated by the study team

2019-09-19

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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).

You may not qualify if…

• 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.

Where it is running

• Columbia University Medical Center — New York, New York, United States

Full record on ClinicalTrials.gov

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