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Lipid, Glycemic, and Insulin Responses to Meals Rich in Different Fatty Acids

This study has been completed.
Sponsor:
Information provided by:
University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier:
NCT00479791
First received: May 24, 2007
Last updated: May 25, 2007
Last verified: May 2007
History of Changes
  Purpose

A meal rich in very-long chain omega-3 fatty acids or oleic acid may lower postprandial insulin levels in comparison to a meal rich in linoleic acid or palmitic acid. A meal rich in very long-chain omega-3 fatty acids may lower postprandial triglyceride levels compared to other fatty acids.


Condition Intervention
Type 2 Diabetes Mellitus
 Behavioral: Test meals rich in different fatty acids

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Lipid, Glycemic, and Insulin Responses to Meals Rich in Saturated, Cis-Monounsaturated, and Polyunsaturated Fatty (n-3 and n-6)Acids in Subjects With Type 2 Diabetes Mellitus

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Texas Southwestern Medical Center:

Primary Outcome Measures:
  • Insulin, and glucose [ Time Frame: 15 days ]

Secondary Outcome Measures:
  • Triglycerides [ Time Frame: 15 days ]

Enrollment: 11
Study Start Date: April 1997
Study Completion Date: June 1999
Detailed Description:

Research Design and Methods: Test meals rich in palmitic acid, linoleic acid, oleic acid, and eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) and containing 1,000 kcal each were administered in a randomized cross-over design every 3 to 4 days to 11 patients with T2DM. Serum insulin, glucose, and triglycerides concentrations were measured for 360 minutes. All subjects received an isoenergic diet of constant composition throughout the study.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Type 2 diabetes mellitus not on insulin therapy

Exclusion Criteria:

  • Thyroid, renal, or hepatic disease, uncontrolled hypertension, anemia, history of ketosis
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00479791

Locations
United States, Texas
UT Southwestern Medical Center at Dallas
Dallas, Texas, United States, 75235-9052
Sponsors and Collaborators
University of Texas Southwestern Medical Center
Investigators
Study Chair: Abhimanyu Garg, MD UT Southwestern Medical Center at Dallas
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00479791     History of Changes
Other Study ID Numbers: M01RR00633
Study First Received: May 24, 2007
Last Updated: May 25, 2007
Health Authority: United States: Institutional Review Board

Keywords provided by University of Texas Southwestern Medical Center:
Type 2 diabetes mellitus
Fatty acids
Postprandial response
 Insulin
Glucose
Triglycerides

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

ClinicalTrials.gov processed this record on May 23, 2013