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

September 8, 2020 updated by: Meredith Hawkins, Albert Einstein College of Medicine

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

18

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • Bronx, New York, United States, 10461
        • Albert Einstein College of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: Placebo
Active Comparator: Pioglitazone
Drug: Pioglitazone 45 mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Whole body in vivo glucose turnover
Time Frame: 6-hour
Measured during 6-hour normoglycemic (90 mg/dl) stepped hyperinsulinemic clamp studies
6-hour

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Albert Einstein College of Medicine

Collaborators

Takeda

Investigators

  • Principal Investigator: Meredith Hawkins, MD, Albert Einstein College of Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2000

Primary Completion (Actual)

July 1, 2011

Study Completion (Actual)

July 1, 2011

Study Registration Dates

First Submitted

September 13, 2005

First Submitted That Met QC Criteria

September 13, 2005

First Posted (Estimate)

September 16, 2005

Study Record Updates

Last Update Posted (Actual)

September 11, 2020

Last Update Submitted That Met QC Criteria

September 8, 2020

Last Verified

September 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2000-200

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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