Exenatide and Weight Loss for Diabetes Prevention

Phase 1

Completed

• Conditions: Pre Diabetes; Insulin Resistance
• Interventions: Drug: placebo; Drug: Exenatide 5 and 10 mcg 2 times a day

• Registration Number: NCT02084654
• Lead Sponsor: Stanford University

Brief Summary

Exenatide, a GLP-1 agonist approved for lowering blood glucose concentrations in patients with type 2 diabetes, has been associated with restoration of the first-phase insulin response when administered intravenously to patients with type 2 diabetes. In longer clinical trials, it is associated with progressive decreases in body weight, and improvement in the dyslipidemia that characterizes insulin resistance, although insulin resistance was not quantified. The investigators will seek to determine whether exenatide would have similar effects in individuals who were not diabetic. in particular, the drug effect on beta cell function and insulin sensitivity would be subject to less confounding by changes in blood glucose in the prediabetic population, allowing for clearer evaluation of the physiological effects of the drug on these metabolic endpoints. The investigators will compare 2 groups of prediabetic insulin resistant individuals, all on a weight loss diet and one group on exenatide and the other on placebo. The investigators will evaluate restoration of first phase insulin response, potential glucose lowering effects, including both reversal of prediabetes and hypoglycemia, and improvement in insulin resistance.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-11
• Primary Completion: 2012-10
• Study Completion: 2013-02
• Study First Submitted: 2013-12-02
• Study First Submitted QC: 2014-03-09
• Study First Posted: 2014-03-12
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-03
• Last Update Posted: 2016-11-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 66

Inclusion Criteria

• Healthy Men and women, BMI 27-37kgm2, Fasting plasma glucose = or > 100 mg/dL and = or < 99 125m g/dl or a 2 hour post OGTT = > 140 mg/dl or = or < 199 mg/dl

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Exclusion Criteria

• Diabetes, Active cardiac, kidney, liver, pulmonary, or other major organ diseases are cause for exclusion. Other exclusionary criteria include: use of corticosteroids, diet medications, antipsychotic medications, history of eating disorder, history of bariatric surgery, active malignancy, recent weight change of more than 2%, inability to attend follow-up visits, excessive alcohol use, investigator's discretion that it is not in patient's best interest

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
placebo	placebo	placebo in addition to weight loss
exenatide 5 and 10 mcg 2 times a day	Exenatide 5 and 10 mcg 2 times a day	Exenatide in addition to weight loss. Starting dose 5 mcg titrate to 10 mcg

Primary Outcome Measures

Name	Time	Method
First-phase insulin response	7 months	measured using ivgtt

Secondary Outcome Measures

Name	Time	Method
glucose lowering effect	8 months	measured by fasting and 2 hr plasma glucose during OGTT