Exenatide and Weight Loss for Diabetes Prevention

NCT02084654 | Completed Phase 1

• 1 other identifier: 9946
• Study Type: interventional
• Target: 66
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Pre Diabetes; Insulin Resistance

Keywords

prediabetes; exenatide; weight loss; insulin resistance; acute insulin response; insulin secretion

Outcome Measures

Primary Outcomes (1)

• First-phase insulin response

  measured using ivgtt

  7 months

Secondary Outcomes (1)

• glucose lowering effect

  8 months

Other Outcomes (1)

• insulin-mediated glucose uptake (insulin sensitivity)

  8 months

Study Arms (2)

exenatide 5 and 10 mcg 2 times a day

ACTIVE COMPARATOR

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

Drug: Exenatide 5 and 10 mcg 2 times a day

placebo

PLACEBO COMPARATOR

placebo in addition to weight loss

Drug: placebo

Interventions

Exenatide 5 and 10 mcg 2 times a day DRUG

Also known as: Byetta

exenatide 5 and 10 mcg 2 times a day

placebo DRUG

placebo

Eligibility Criteria

• Age: 30 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

Sponsors & Collaborators

• Stanford University: lead

MeSH Terms

Conditions

Glucose Intolerance; Insulin Resistance; Prediabetic State; Weight Loss

Interventions

Exenatide

Condition Hierarchy (Ancestors)

Hyperglycemia; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Hyperinsulinism; Diabetes Mellitus; Endocrine System Diseases; Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Peptides; Amino Acids, Peptides, and Proteins; Venoms; Complex Mixtures; Toxins, Biological; Biological Factors

Study Officials

• Tracey McLaughlin, MS, MD

  Stanford University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: December 2, 2013
• First Posted: March 12, 2014
• Study Start: November 1, 2007
• Primary Completion: October 1, 2012
• Study Completion: February 1, 2013
• Last Updated: November 4, 2016

Record last verified: 2016-11

Data Sharing

• IPD Sharing: Will not share