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NCT Number: NCT03866408

Insulin Regulation of Lipolysis and Lipolysis Proteins

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.

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Key information

Conditions

Obesity Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location status: Recruiting

Location contact

Pamela A Reich

CONTACT

[email protected]

507-255-6062

About this study

  • The investigators will determine whether impaired insulin-induced suppression of lipolysis (as measured by IC50) is related to the above mentioned lipolysis proteins in groups of volunteers known to vary widely with regards to abdominal adipocyte size and regulation of adipose tissue lipolysis.
  • The investigators will determine whether the improved insulin regulation of lipolysis resulting from treatment with the PPARγ agonist pioglitazone, with or without weight loss, can be linked to specific changes in sets of PPARγ-responsive adipocyte lipolysis proteins in UBO adults.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Immediate weight loss

Behavioral

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

pioglitazone

Drug

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

Deferred weight loss

Behavioral

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

Drug

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

Primary outcomes

  1. Adipocyte response to insulin - perilipin 1 and FSP27 relative to HSL and ATGL

    Time frame: 4-9 months

    In response to weight maintenance vs. weight loss with pioglitazone vs. placebo, insulin regulation of lipolysis in upper body obese as measured by insulin IC50 for palmitate flux and compared to adipocyte perilipin 1 and FSP27 relative to HSL and ATGL.

  2. Adipocyte response to insulin - adipocyte G0S2 relative to ATGL.

    Time frame: 4-9 months

    In response to weight maintenance vs. weight loss with pioglitazone vs. placebo, insulin regulation of lipolysis in upper body obese as measured by insulin IC50 for palmitate flux and compared to adipocyte G0S2 relative to ATGL.

  3. Adipocyte response to insulin - adipocyte CGI-58 relative to ATGL

    Time frame: 4-9 months

    In response to weight maintenance vs. weight loss with pioglitazone vs. placebo, insulin regulation of lipolysis in upper body obese as measured by insulin IC50 for palmitate flux and compared to adipocyte CGI-58 relative to ATGL.

  4. Adipocyte response to insulin - perilipin 1, ATGL and HSL phosphorylation

    Time frame: 4-9 months

    In response to weight maintenance vs. weight loss with pioglitazone vs. placebo, insulin regulation of lipolysis in upper body obese as measured by insulin IC50 for palmitate flux and compared to adipocyte perilipin 1, ATGL and HSL phosphorylation in response to insulin.

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Collaborators

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

Registry information

Important dates

Study start
2018
Primary completion
2026
Study completion
2026
First posted
Mar 7, 2019
Registry last updated
Jan 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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