Recruiting
Early Phase 1

Insulin Regulation

Sponsor:

Mayo Clinic

Code:

NCT03866408

Conditions

Obesity

Eligibility Criteria

Sex: All

Age: 18 - 55

Healthy Volunteers: Accepted

Interventions

Immediate weight loss

Pioglitazone

Deferred weight loss

Placebo

Study Details

Brief 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

Obesity

Study ID

NCT03866408

Start date

Nov 12, 2018

Status verified date

Jan, 2026

Completion date

Dec 31, 2026

Anticipated

Primary completion date

Dec 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 55

Healthy Volunteers: Accepted

Inclusion Criteria:

  • Men and Women between the ages of 18 and 55.
  • Women will be premenopausal
  • Non obese adults BMI between 18-25
  • Obese BMI 30-38

Exclusion Criteria, Pioglitazone package insert of contraindications for use:

  • Initiation in patients with established New York Heart Associations (NYHA) class III or IV Heart failure.
  • Use in patients with known hypersensitivity to pioglitazone or any other component of ACTOSE.

Study Design

Enrollment

64 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

active comparator: Immediate weight loss - placebo

Upper body obese participants randomized to this group; all will begin their immediate participation in a comprehensive lifestyle obesity treatment program after completion of baseline studies. Half of the volunteers will be randomized to placebo during this period.

placebo comparator: Deferred control group - placebo

After baseline studies, UBO participants randomized to this group will wait without any intervention for 4 months, with continued monitoring to assure weight stability - this group will be the half of volunteers randomized to deferred weight loss intervention that are also randomized to placebo. At the end of this 'wait' period they will be enrolled in the same comprehensive lifestyle obesity treatment program for 4 months, but without placebo.

active comparator: Immediate weight loss - pioglitazone

Upper body obese participants randomized to this group; all will begin their immediate participation in a comprehensive lifestyle obesity treatment program after completion of baseline studies. Half of the volunteers will be randomized to pioglitazone during this period.

active comparator: Deferred group - pioglitazone

After baseline studies, UBO participants randomized to this group will wait without any intervention for 4 months, with continued monitoring to assure weight stability - this group will be the half of volunteers randomized to deferred weight loss intervention that are randomized to pioglitazone. They will be monitored to prevent the usual but modest weight gain associated with pioglitazone. They will be on pioglitazone during the 'wait' period.

At the end of this 'wait' period they will be enrolled in the same comprehensive lifestyle obesity treatment program for 4 months, but without pioglitazone.

Interventions

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.

Pioglitazone

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

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.

Placebo

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

Primary outcome measure

  • Adipocyte response to insulin - perilipin 1 and FSP27 relative to HSL and ATGL [ Time Frame: 4-9 months ]
  • Adipocyte response to insulin - adipocyte G0S2 relative to ATGL. [ Time Frame: 4-9 months ]
  • Adipocyte response to insulin - adipocyte CGI-58 relative to ATGL [ Time Frame: 4-9 months ]
  • Adipocyte response to insulin - perilipin 1, ATGL and HSL phosphorylation [ Time Frame: 4-9 months ]

Central Contacts and Locations

Locations

Mayo Clinic in Rochester

Recruiting

Rochester, Minnesota, United States, 55905

Contacts

Pamela A Reich

507-255-6062reich.pamela@mayo.edu

More Information

Sponsor

Mayo Clinic

Last update posted

Jan 28, 2026

Last verified

Jan, 2026

Keywords

  • adipose tissue

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Mayo Clinic on 2026-01-28.