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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00179400
First Posted: September 16, 2005
Last Update Posted: July 2, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Takeda
Information provided by (Responsible Party):
Meredith Hawkins, Albert Einstein College of Medicine, Inc.
  Purpose
Doctors are studying natural oils as potential therapies for type 2 diabetes. Animal studies have suggested promising results using EPA (found in fish oils) to improve insulin action and lower blood sugar levels.

Condition Intervention
Type 2 Diabetes Mellitus Drug: Pioglitazone/EPA Drug: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: The Role of Acute Combined Peroxisome Proliferator-Activated Receptors (PPAR) Alpha and Gamma Stimulation on Insulin Action in Humans

Resource links provided by NLM:


Further study details as provided by Meredith Hawkins, Albert Einstein College of Medicine, Inc.:

Primary Outcome Measures:
  • Whole body in vivo glucose turnover [ Time Frame: 6-hour ]
    Measured during 6-hour normoglycemic (90 mg/dl) stepped hyperinsulinemic clamp studies


Enrollment: 18
Actual Study Start Date: December 2000
Study Completion Date: July 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Pioglitazone Drug: Pioglitazone/EPA
Placebo Comparator: Placebo Drug: Placebo

Detailed Description:

PARTICIPATION INCLUDES: Participation in the studies includes taking study capsules for up to 21 days, keeping a meal diary, and up to four overnight hospital stays. During the hospital visits, an IV will be placed in each arm, and small amounts of muscle and fat tissue will be removed (with minimal discomfort).

COMPENSATION: Compensation of $400 per study is provided (or up to $1,600 for completing all studies)

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Type 2 subjects with an A1c over 8.%

Exclusion Criteria:

Those with bleeding disorders including GERD, PUD, any GI bleeding; High blood pressure, and anyone with a history of Coronary Artery Disease or exertional chest pain

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00179400


Locations
United States, New York
Albert Einstein College of Medicine
The Bronx, New York, United States, 10461
Sponsors and Collaborators
Albert Einstein College of Medicine, Inc.
Takeda
Investigators
Principal Investigator: Meredith Hawkins, MD Albert Einstein College of Medicine, Inc.
  More Information

Responsible Party: Meredith Hawkins, Professor, Albert Einstein College of Medicine, Inc.
ClinicalTrials.gov Identifier: NCT00179400     History of Changes
Other Study ID Numbers: 2000-200
First Submitted: September 13, 2005
First Posted: September 16, 2005
Last Update Posted: July 2, 2017
Last Verified: June 2017

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Pioglitazone
Hypoglycemic Agents
Physiological Effects of Drugs