Insulin Regulation of Lipolysis and Lipolysis Proteins

Obesity Clinical Trial

Official title:

Insulin Regulation of Lipolysis and Lipolysis Proteins

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03866408
• Other study ID #: 17-009837
• Secondary ID: 2R01DK040484-30
• Status: Recruiting
• Phase: Early Phase 1
• Start date: November 12, 2018
• Est. completion date: December 2024

Study information

• Verified date: October 2023
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

1. 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. 2. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 64
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Obesity

Intervention

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.

Locations

Country	Name	City	State
United States	Mayo Clinic in Rochester	Rochester	Minnesota

Sponsors (2)

Lead Sponsor	Collaborator
Mayo Clinic	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adipocyte response to insulin - perilipin 1 and FSP27 relative to HSL and ATGL	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.	4-9 months
Primary	Adipocyte response to insulin - adipocyte G0S2 relative to ATGL.	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.	4-9 months
Primary	Adipocyte response to insulin - adipocyte CGI-58 relative to ATGL	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.	4-9 months
Primary	Adipocyte response to insulin - perilipin 1, ATGL and HSL phosphorylation	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.	4-9 months

External Links

•   Mayo Clinic Clinical Trials