Clinical trial NCT00179400: The Role of Acute Combined PPAR Alpha and Gamma Stimulation on Insulin Action in Humans
Official title: The Role of Acute Combined Peroxisome Proliferator-Activated Receptors (PPAR) Alpha and Gamma Stimulation on Insulin Action in Humans
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Type 2 Diabetes Mellitus
Keywords: Type 2 Diabetes Mellitus
Lead sponsor: Albert Einstein College of Medicine
Sponsor class: OTHER
Collaborators: name: Takeda
First posted: 2005-09-16
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to investigate the acute effects of the thiazolidinedione agent pioglitazone (which has combined PPAR alpha and gamma stimulation) on insulin's ability to suppress glucose production, stimulated glucose uptake, and impact a number of other metabolically important endpoints, including production of adiponectin (a protein hormone which regulates sugar levels and fatty acid breakdown) in subjects with type 2 diabetes.

Detailed description: Participants in this study were given a supply of either pioglitazone (a medication used to treat diabetes) or matched placebo for a duration of 10 days or 21 days. Changes to the body's response to insulin in the liver and in peripheral tissues (eg, muscle and fat) will be measured using a procedure called a pancreatic clamp. During the clamp procedure, glucose (a sugar) and insulin were infused with an intravenous catheter, and blood samples were collected periodically throughout the procedure to measure blood sugar levels and the levels of several hormones that are found in the body and are related to glucose metabolism. Small amounts of muscle and fat tissue were also taken during this study to measure changes in gene expression after taking the medication/placebo.

Eligibility criteria: Inclusion Criteria:

• Individuals with Type 2 Diabetes

Exclusion Criteria:

* Individuals with bleeding disorders including gastrointestinal reflux disease (GERD), peptic ulcer disease (PUD), any gastrointestinal (GI) bleeding
* High blood pressure
* History of Coronary Artery Disease or chest pain on exertion

Primary outcomes:
measure: Endogenous Glucose Production (EGP)
timeFrame: Up to 6 hours
measure: Glucose Rates of Disappearance (Rd)
timeFrame: Up to 6 hours
Secondary outcomes:
measure: Gene Expression in Both Whole Fat Tissue and Isolated Macrophages
timeFrame: Outcome was compared prior to and post 10-day or 21-day administration of either placebo or Pioglitazone
measure: Effects of Pioglitazone on Adipose Tissue Percentage of Macrophage Content
timeFrame: Assessed at day 1 prior to the intervention and on day 10 or 21 following the intervention, day 10 or 21 following the intervention reported
measure: Adipose Tissue Percentage of Macrophage Content
timeFrame: Outcome was compared between Pioglitazone and placebo group prior to and after 21-day administration
measure: Adipose Tissue Regulatory T Lymphocyte Content
timeFrame: Outcome was compared between Pioglitazone and placebo group prior to and after 21-day administration
Other outcomes:
Locations:
city: Bronx
country: United States
facility: Albert Einstein College of Medicine
state: New York
Study officials:
affiliation: Albert Einstein College of Medicine
name: Meredith Hawkins, M.D., M.S.
role: PRINCIPAL_INVESTIGATOR
References: