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Regulation of Insulin Secretion by the GLP-1 Receptor

NCT02844907 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2024-12-12

Study results available
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Summary

AIM2: The purpose of Aim-2 of this study is to determine the role of basal GLP-1 action on the beta-cell response to insulin resistance. Healthy subjects will have fasting GLP-1 action determined with GLP-1r blockade before and after induction of experimental insulin resistance. The investigators hypothesize that fasting GLP-1 action will increase to compensate for experimental insulin resistance.

AIM3: The purpose of Aim-3 of this study is to determine the role of basal GLP-1 action on fasting glucose regulation in lean, obese, pre-diabetic and type 2 diabetic (T2DM) subjects. A cross sectional study of age-matched subjects across the spectrum of glucose tolerance will be used to test the hypothesis that fasting GLP-1 action increases as beta-cell function declines.

Conditions

  • Insulin Secretion

Interventions

DRUG

Exendin (9-39)

Upon establishing a hyperglycemic clamp (target blood glucose at basal +3 mM) Exendin (9-39) will be infused.

DRUG

Dexamethasone

Between Visit-2 and Visit-3, Dexamethasone (4 mg tablet) once daily for 5-7 days.

OTHER

Hyperglycemic Clamp

A variable infusion of 20% dextrose will begin to clamp the blood glucose at basal +3 mM.

Sponsors & Collaborators

  • Durham VA Medical Center

    collaborator FED

  • VA Office of Research and Development

    lead FED

Principal Investigators

  • David D'Alessio, MD · Durham VA Medical Center, Durham, NC

Study Design

Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-07-01
Primary Completion
2021-12-31
Completion
2021-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02844907 on ClinicalTrials.gov