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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Takeda Global Research & Development Center, Inc.
Information provided by:
Albert Einstein College of Medicine of Yeshiva University
ClinicalTrials.gov Identifier:
NCT00179400
First received: September 13, 2005
Last updated: March 7, 2012
Last verified: March 2012
History of Changes
  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

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Single Group Assignment
Masking: Double-Blind
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:

U.S. FDA Resources

Further study details as provided by Albert Einstein College of Medicine of Yeshiva University:

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

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00179400

Locations
United States, New York
Albert Einstein College of Medicine
Bronx, New York, United States, 10461
Sponsors and Collaborators
Albert Einstein College of Medicine of Yeshiva University
Takeda Global Research & Development Center, Inc.
Investigators
Principal Investigator: Meredith Hawkins, MD Albert Einstein College of Medicine of Yeshiva University
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00179400     History of Changes
Other Study ID Numbers: 2000-200
Study First Received: September 13, 2005
Last Updated: March 7, 2012
Health Authority: United States: Institutional Review Board

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
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 21, 2013