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Exenatide and Weight Loss for Diabetes Prevention

NCT ID: NCT02084654

Last Updated: 2016-11-04

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

Clinical Phase

PHASE1

Total Enrollment

66 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-11-30

Study Completion Date

2013-02-28

Brief Summary

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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

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Conditions

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Pre Diabetes Insulin Resistance

Keywords

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prediabetes exenatide weight loss insulin resistance acute insulin response insulin secretion

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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exenatide 5 and 10 mcg 2 times a day

Exenatide in addition to weight loss. Starting dose 5 mcg titrate to 10 mcg

Group Type ACTIVE_COMPARATOR

Exenatide 5 and 10 mcg 2 times a day

Intervention Type DRUG

placebo

placebo in addition to weight loss

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

Interventions

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Exenatide 5 and 10 mcg 2 times a day

Intervention Type DRUG

placebo

Intervention Type DRUG

Other Intervention Names

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Byetta

Eligibility Criteria

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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

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
Minimum Eligible Age

30 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Stanford University

OTHER

Sponsor Role lead

Responsible Party

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Tracey McLaughlin

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Tracey McLaughlin, MS, MD

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Other Identifiers

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9946

Identifier Type: -

Identifier Source: org_study_id