Insulin Action in Individuals With Type 2 Diabetes by Natural Fatty Acids or the Medication Pioglitazone

Type 2 Diabetes Mellitus Clinical Trial

Official title:

The Role of Acute Combined Peroxisome Proliferator-Activated Receptors (PPAR) Alpha and Gamma Stimulation on Insulin Action in Humans

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00179400
• Other study ID #: 2000-200
• Status: Completed
• Phase: Phase 4
• Start date: December 2000
• Est. completion date: July 2011

Study information

• Verified date: September 2020
• Source: Albert Einstein College of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to investigate the changes in insulin (a hormone produced in the body by the pancreas that regulates the amount of sugar in the blood) action and adiponectin (a protein hormone which regulates sugar levels and fatty acid breakdown) levels after giving individuals with type 2 diabetes a medication, pioglitazone, for three weeks.

Description:

Participants in this study will be given a 21 day supply of either pioglitazone (a medication used to treat diabetes) or a placebo. 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 are infused with an intravenous catheter, and blood samples are 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 will also be taken during this study to measure changes in gene expression after taking the medication/placebo for 3 weeks.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: July 2011
• Est. primary completion date: July 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Individuals with Type 2 Diabetes

• HbA1c over 8%

Exclusion Criteria:

• Individuals with bleeding disorders including GERD, PUD, any GI bleeding

• High blood pressure

• History of Coronary Artery Disease or exertional chest pain

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

Drug:
• Pioglitazone 45 mg

• Placebo

Locations

Country	Name	City	State
United States	Albert Einstein College of Medicine	Bronx	New York

Sponsors (2)

Lead Sponsor	Collaborator
Albert Einstein College of Medicine	Takeda

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Whole body in vivo glucose turnover	Measured during 6-hour normoglycemic (90 mg/dl) stepped hyperinsulinemic clamp studies	6-hour