Exenatide and Weight Loss for Diabetes Prevention

November 3, 2016 updated by: Tracey McLaughlin, Stanford University

Randomized Trial Investigating Exenatide for Diabetes Prevention in Obese, Insulin-Resistant Individuals With Prediabetes

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

66

Phase

  • Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: exenatide 5 and 10 mcg 2 times a day
Exenatide in addition to weight loss. Starting dose 5 mcg titrate to 10 mcg
Drug: Exenatide 5 and 10 mcg 2 times a day
Other Names:
  • Byetta
Placebo Comparator: placebo
placebo in addition to weight loss
Drug: placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
First-phase insulin response
Time Frame: 7 months
measured using ivgtt
7 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
glucose lowering effect
Time Frame: 8 months
measured by fasting and 2 hr plasma glucose during OGTT
8 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
insulin-mediated glucose uptake (insulin sensitivity)
Time Frame: 8 months
This is measured by the SSPG, or modified insulin-suppression test. it is a "gold standard" measurement of insulin-mediated glucose uptake, and is precise and quantitative.
8 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Stanford University

Investigators

  • Principal Investigator: Tracey McLaughlin, MS, MD, Stanford University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2007

Primary Completion (Actual)

October 1, 2012

Study Completion (Actual)

February 1, 2013

Study Registration Dates

First Submitted

December 2, 2013

First Submitted That Met QC Criteria

March 9, 2014

First Posted (Estimate)

March 12, 2014

Study Record Updates

Last Update Posted (Estimate)

November 4, 2016

Last Update Submitted That Met QC Criteria

November 3, 2016

Last Verified

November 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 9946

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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