Back to resultsLipid, Glycemic, and Insulin Responses to Meals Rich in Different Fatty Acids
Primary Purpose
Type 2 Diabetes Mellitus
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Test meals rich in different fatty acids
Sponsored by
About this trial
This is an interventional treatment trial for Type 2 Diabetes Mellitus focused on measuring Type 2 diabetes mellitus, Fatty acids, Postprandial response, Insulin, Glucose, Triglycerides
Eligibility Criteria
Inclusion Criteria:
- Type 2 diabetes mellitus not on insulin therapy
Exclusion Criteria:
- Thyroid, renal, or hepatic disease, uncontrolled hypertension, anemia, history of ketosis
Sites / Locations
- UT Southwestern Medical Center at Dallas
Outcomes
Primary Outcome Measures
Insulin, and glucose
Secondary Outcome Measures
Triglycerides
Full Information
NCT ID
NCT00479791
First Posted
May 24, 2007
Last Updated
May 25, 2007
Sponsor
University of Texas Southwestern Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT00479791
Brief Title
Lipid, Glycemic, and Insulin Responses to Meals Rich in Different Fatty Acids
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 Type
Interventional
2. Study Status
Record Verification Date
May 2007
Overall Recruitment Status
Completed
Study Start Date
April 1997 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
June 1999 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
University of Texas Southwestern Medical Center
4. Oversight
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes Mellitus
Keywords
Type 2 diabetes mellitus, Fatty acids, Postprandial response, Insulin, Glucose, Triglycerides
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
11 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Behavioral
Intervention Name(s)
Test meals rich in different fatty acids
Primary Outcome Measure Information:
Title
Insulin, and glucose
Time Frame
15 days
Secondary Outcome Measure Information:
Title
Triglycerides
Time Frame
15 days
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Type 2 diabetes mellitus not on insulin therapy
Exclusion Criteria:
Thyroid, renal, or hepatic disease, uncontrolled hypertension, anemia, history of ketosis
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Abhimanyu Garg, MD
Organizational Affiliation
UT Southwestern Medical Center at Dallas
Official's Role
Study Chair
Facility Information:
Facility Name
UT Southwestern Medical Center at Dallas
City
Dallas
State/Province
Texas
ZIP/Postal Code
75235-9052
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Lipid, Glycemic, and Insulin Responses to Meals Rich in Different Fatty Acids
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