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

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ClinicalTrials.gov Identifier: NCT00479791
Recruitment Status : Completed
First Posted : May 28, 2007
Last Update Posted : May 28, 2007
Information provided by:

Study Description
Brief Summary:
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 or disease Intervention/treatment
Type 2 Diabetes Mellitus Behavioral: Test meals rich in different fatty acids

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.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 11 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (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
Study Start Date : April 1997
Study Completion Date : June 1999

Resource links provided by the National Library of Medicine

Drug Information available for: Insulin
U.S. FDA Resources

Arms and Interventions

Outcome Measures

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

Secondary Outcome Measures :
  1. Triglycerides [ Time Frame: 15 days ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

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): NCT00479791

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

ClinicalTrials.gov Identifier: NCT00479791     History of Changes
Other Study ID Numbers: M01RR000633 ( U.S. NIH Grant/Contract )
First Posted: May 28, 2007    Key Record Dates
Last Update Posted: May 28, 2007
Last Verified: May 2007

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

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