Insulin Regulation of Lipolysis and Lipolysis Proteins
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Immediate weight loss, Pioglitazone, Deferred weight loss, Placebo.
- Who it may be relevant to
- Registry conditions: Obesity. Basic parameters: 18 years — 55 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Detailed 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.
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.
Primary outcome measures
- 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]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Basic science
Study locations
United States · 1 center
- Mayo Clinic in Rochester — Rochester
Identifiers
NCT: NCT03866408 · 17-009837 · 2R01DK040484-30