Exenatide and Weight Loss for Diabetes Prevention

Insulin Resistance Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02084654
• Other study ID #: 9946
• Status: Completed
• Phase: Phase 1
• First received: December 2, 2013
• Last updated: November 3, 2016
• Start date: November 2007
• Est. completion date: February 2013

Study information

• Verified date: November 2016
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: February 2013
• Est. primary completion date: October 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 30 Years to 70 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator)

Related Conditions & MeSH terms

• Diabetes Mellitus
• Glucose Intolerance
• Insulin Resistance
• Pre Diabetes
• Prediabetic State

Intervention

Drug:
• Exenatide 5 and 10 mcg 2 times a day

• placebo

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Stanford University

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	insulin-mediated glucose uptake (insulin sensitivity)	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	No
Primary	First-phase insulin response	measured using ivgtt	7 months	No
Secondary	glucose lowering effect	measured by fasting and 2 hr plasma glucose during OGTT	8 months	No