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Effect of Physiologic Hyperglucogonemia on Adipocyte Metabolism

NCT04300049 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2024-10-21

No results posted yet for this study

Summary

Purpose/Objectives: To investigate the effect of hyperglucagonemia on insulin action, particularly on adipose tissue.

Research Design/Plan: Normal glucose tolerant subjects will be studied. Study subjects will receive a continuous glucagon infusion for 12 hours. Following glucagon infusion, subjects will receive prime-continuous tracer infusions for additional 4 hours to measure adipocyte metabolism. Within 6-8 weeks, subjects will return for a repeat study with normal saline as a control group.

Methods: All subjects will have an oral glucose tolerance test prior to participation to confirm they are normal glucose tolerant. Subjects will be admitted to the CRC at 4 PM and will receive a continuous glucagon for 12 hours. At 6 AM on the following morning, subjects will receive prime-continuous tracer infusions of the following for 4 hours (14C-glycerol, 3-3H glucose, and D2O). At 10 AM continuous indirect calorimetry will be performed to determine rates of energy expenditure and glucose/lipid oxidation for 40 minutes. At 6 AM a surgical biopsy of abdominal adipose tissue will be performed for measurement of adipocyte metabolism. At 8 AM, the study team will infuse insulin/glucose to test for insulin sensitivity.

Clinical Relevance: The results of this study will help the study team to further understand the pathophysiology of metabolic disturbances that is induced by hyperglucagonemia in type 2 diabetes patients.

Conditions

  • Insulin Sensitivity

Interventions

DRUG

Glucagon Infusion

Study participants will receive glucagon infusion (6ug/kg/min for 12 hours) 12 hours.

OTHER

Saline

Study participants will receive saline infusion for 12 hours.

Sponsors & Collaborators

  • South Texas Veterans Health Care System

    collaborator FED

  • The University of Texas Health Science Center at San Antonio

    lead OTHER

Principal Investigators

  • Ralph DeFronzo, MD · University of Texas Health San Antonio

Study Design

Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2018-02-05
Primary Completion
2023-11-15
Completion
2023-11-15
FDA Drug
Yes

Countries

  • United States

Study Locations

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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 NCT04300049 on ClinicalTrials.gov