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

Phase 4

Completed

• Conditions: Type 2 Diabetes Mellitus
• Interventions: Drug: Placebo; Drug: Pioglitazone 45 mg

• Registration Number: NCT00179400
• Lead Sponsor: Albert Einstein College of Medicine

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2000-12
• Study First Submitted: 2005-09-13
• Study First Submitted QC: 2005-09-13
• Study First Posted: 2005-09-16
• Primary Completion: 2011-07
• Study Completion: 2011-07
• Disposition First Submitted: 2020-08-24
• Status Verified: 2020-09
• Disposition First Submitted QC: 2020-09-08
• Last Update Submitted: 2020-09-08
• Disposition First Posted: 2020-09-11
• Last Update Posted: 2020-09-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

Inclusion Criteria

• Individuals with Type 2 Diabetes
• HbA1c over 8%

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Exclusion Criteria

• Individuals with bleeding disorders including GERD, PUD, any GI bleeding
• High blood pressure
• History of Coronary Artery Disease or exertional chest pain

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	-
Pioglitazone	Pioglitazone 45 mg	-

Primary Outcome Measures

Name	Time	Method
Whole body in vivo glucose turnover	6-hour	Measured during 6-hour normoglycemic (90 mg/dl) stepped hyperinsulinemic clamp studies

Trial Locations

Locations (1)

Albert Einstein College of Medicine; 🇺🇸 Bronx, New York, United States