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Insulin Regulation of Lipolysis and Lipolysis Proteins

NCT03866408 · Status: RECRUITING · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 64

Last updated 2026-01-28

No results posted yet for this study

Summary

These studies will define the abnormalities in the adipocyte proteins that are involved in the failure of insulin to suppress lipolysis normally in humans with upper body obesity and will help discover the mechanism by which pioglitazone, a medication used to treat type 2 diabetes and improve insulin resistance, improves insulin-regulation of adipocyte fatty acid metabolism.

Conditions

Interventions

BEHAVIORAL

Immediate weight loss

Upper body obese subjects will undergo behavioral intervention with a life coach and a physical activity program of their choice for 4 months.

DRUG

Pioglitazone

Upper body obese subjects will be block randomized to pioglitazone or placebo at enrollment.

BEHAVIORAL

Deferred weight loss

Upper body obese subjects will complete a weight-stable period of 4 months and subsequently undergo behavioral intervention with a life coach and a physical activity program of their choice for 4 months.

DRUG

Placebo

Upper body obese subjects will be block randomized to pioglitazone or placebo at enrollment.

Sponsors & Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

    collaborator NIH

  • Mayo Clinic

    lead OTHER

Principal Investigators

  • Michael D Jensen · Mayo Clinic

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
TRIPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2018-11-12
Primary Completion
2026-12-30
Completion
2026-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases
Companies

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 NCT03866408 on ClinicalTrials.gov