The Role of Acute Combined PPAR Alpha and Gamma Stimulation on Insulin Action in Humans

Albert Einstein College of Medicine

Status and phase: Completed; Phase 4

Conditions: Type 2 Diabetes Mellitus

Treatments: Drug: Pioglitazone; Procedure: Pancreatic Clamp Study; Drug: Placebo

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00179400

2000-200

Details and patient eligibility

About

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.

Full 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.

Enrollment: 26 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

---

26 participants in 2 patient groups, including a placebo group

Pioglitazone

Active Comparator group

Description:

Participants received Pioglitazone 45 mg via oral capsule daily for 10 or 21 days in randomized, placebo-controlled crossover fashion, separated by a wash-out period. The investigators used a research procedure called a "pancreatic clamp" study to study the effects of the pioglitazone. During the clamp procedure, glucose (a sugar) and insulin (a hormone produced in the pancreas that regulates the amount of glucose in the blood) 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 related to glucose metabolism.

Treatment:

Procedure: Pancreatic Clamp Study

Drug: Pioglitazone

Placebo

Placebo Comparator group

Description:

Participants received matched placebo via oral capsule daily for 10 or 21 days in randomized, placebo-controlled crossover fashion, separated by a wash-out period. The investigators used a research procedure called a "pancreatic clamp" study to study the effects of the pioglitazone. During the clamp procedure, glucose (a sugar) and insulin (a hormone produced in the pancreas that regulates the amount of glucose in the blood) 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 related to glucose metabolism.

Treatment:

Drug: Placebo

Procedure: Pancreatic Clamp Study