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

Primary Purpose

Type 2 Diabetes Mellitus

Status

Completed

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

Pioglitazone 45 mg

Placebo

About this trial

This is an interventional treatment trial for Type 2 Diabetes Mellitus

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Albert Einstein College of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Pioglitazone

Placebo

Arm Description

Outcomes

Primary Outcome Measures

Whole body in vivo glucose turnover

Measured during 6-hour normoglycemic (90 mg/dl) stepped hyperinsulinemic clamp studies

Secondary Outcome Measures

Full Information

NCT ID

NCT00179400

First Posted

September 13, 2005

Last Updated

September 8, 2020

Sponsor

Albert Einstein College of Medicine

Collaborators

Takeda

1. Study Identification

Unique Protocol Identification Number

NCT00179400

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2020

Overall Recruitment Status

Completed

Study Start Date

December 2000 (Actual)

Primary Completion Date

July 2011 (Actual)

Study Completion Date

July 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Albert Einstein College of Medicine

Collaborators

Takeda

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Type 2 Diabetes Mellitus

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Crossover Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

18 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Pioglitazone

Arm Type

Active Comparator

Arm Title

Placebo

Arm Type

Placebo Comparator

Intervention Type

Drug

Intervention Name(s)

Pioglitazone 45 mg

Intervention Type

Drug

Intervention Name(s)

Placebo

Primary Outcome Measure Information:

Title

Whole body in vivo glucose turnover

Description

Measured during 6-hour normoglycemic (90 mg/dl) stepped hyperinsulinemic clamp studies

Time Frame

6-hour

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Meredith Hawkins, MD

Organizational Affiliation

Albert Einstein College of Medicine

Official's Role

Principal Investigator

Facility Information:

Facility Name

Albert Einstein College of Medicine

City

Bronx

State/Province

New York

ZIP/Postal Code

10461

Country

United States

12. IPD Sharing Statement

Learn more about this trial

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

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