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

• Sponsor: University of Texas Southwestern Medical Center (Other)
• Overall Status: Completed
• CT.gov ID: NCT00479791
• Collaborator: (none)
• Enrollment: 11
• Location: 1
• Duration (Months): 26
• Patients Per Site Per Month: 0.4

Study Details

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	Phase
Type 2 Diabetes Mellitus	Behavioral: Test meals rich in different fatty acids	N/A

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
• 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: Apr 1, 1997
• Actual Study Completion Date: Jun 1, 1999

Outcome Measures

Primary Outcome Measures

1. Insulin, and glucose [15 days]

Secondary Outcome Measures

1. Triglycerides [15 days]

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• 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

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00479791
• Other Study ID Numbers: M01RR000633
• First Posted: May 28, 2007
• Last Update Posted: May 28, 2007
• Last Verified: May 1, 2007

• Keywords provided by , ,: Type 2 diabetes mellitus; Fatty acids; Postprandial response; Insulin; Glucose; Triglycerides
• Additional relevant MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2

Study Results

No Results Posted as of May 28, 2007