Effect of GLP-1 on Insulin Biosynthesis and Turnover Rates

Sponsor

Albert Einstein College of Medicine (Other)

Overall Status

Completed

CT.gov ID

NCT00609154

Collaborator

Merck Sharp & Dohme LLC (Industry)

Enrollment

Location

Arms

128

Duration (Months)

0.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The gut hormone glucagon like peptide-1 (GLP-1) has been shown to have important effects on maintaining the function and health of the insulin producing beta cells. This hormone is known to increase the production rate of new insulin as well as increase the release of insulin into the blood. We will measure the rate of new insulin production in subjects with Type 2 diabetes compared to non diabetic subjects. We hypothesize that subjects with Type 2 diabetes make less insulin in response to GLP-1 compared to non diabetic subjects.

Condition or Disease	Intervention/Treatment	Phase
Type 2 Diabetes	Drug: glucagon like peptide-1 Dietary Supplement: glucose control	Phase 1/Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

16 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Basic Science

Official Title:

Effect of GLP-1 on Insulin Biosynthesis and Turnover Rates

Study Start Date :

Nov 1, 2007

Actual Primary Completion Date :

Jul 1, 2018

Actual Study Completion Date :

Jul 1, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Diabetic Group Participants with Type 2 diabetes	Drug: glucagon like peptide-1 GLP-1 1 pmole/kg/min Dietary Supplement: glucose control glucose without GLP-1
Active Comparator: Non-diabetic Group Participants who are non-diabetic will serve as control. treatment is matched to experimental group	Drug: glucagon like peptide-1 GLP-1 1 pmole/kg/min Dietary Supplement: glucose control glucose without GLP-1

Arm

Intervention/Treatment

Experimental: Diabetic Group

Participants with Type 2 diabetes

Drug: glucagon like peptide-1

GLP-1 1 pmole/kg/min

Dietary Supplement: glucose control

glucose without GLP-1

Active Comparator: Non-diabetic Group

Participants who are non-diabetic will serve as control. treatment is matched to experimental group

Drug: glucagon like peptide-1

GLP-1 1 pmole/kg/min

Dietary Supplement: glucose control

glucose without GLP-1

Outcome Measures

Primary Outcome Measures

Insulin biosynthesis rate [24 hours]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Type 2 Diabetes
Non diabetic

Exclusion Criteria:

Currently taking medication such as thiazolidinediones, metformin, Exenatide, or sitagliptin
Chronic condition such as chronic heart failure CHF), Coronary Artery Disease (CAD), or chronic renal failure (CRF)
Anemia