Optimal Dietary Fat Pattern to Prevent Cardiovascular Disease Among Type 2 Diabetes
Primary Purpose
Type 2 Diabetes Mellitus
Status
Completed
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
Diet
Sponsored by

About this trial
This is an interventional prevention trial for Type 2 Diabetes Mellitus focused on measuring dietary fatty acid composition, postprandial, triglyceride-rich lipoprotein, type 2 diabetes
Eligibility Criteria
Inclusion Criteria:
- Type 2 diabetes;
- Types and doses of antidiabetic agents had been unchanged for four weeks before the postprandial study;
- Nonsmokers;
- No prior cardiovascular disease, hepatic and renal diseases, or other diseases influencing fat absorption;
- No previous history of gastro-enteral surgery;
- Dietary fat provided energy less than 35% in last two weeks;
- No use of medications or vitamins known to affect plasma lipids;
- Ability to hold hypoglycemic drugs on the day of the study until postprandial tests are completed;
- Ability to provide verbal informed consent to participate.
Exclusion Criteria:
- Females with menstrual cycles
Sites / Locations
- Department of Clinical Nutrition, School of Public Health, Sun Yat-sen University
- Department of Endocrinology, The First Hospital, Sun Yat-sen University
Outcomes
Primary Outcome Measures
Lipids including triglyceride and cholesterol in four subfractions of ppTRLs.
Secondary Outcome Measures
Apolipoproteins including apoB100 and apoA1 in the postprandial plasma
Lipoproteins including high- and low-density lipoproteins in the postprandial plasma
Lipids lipoproteins in the postprandial plasma
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00467168
Brief Title
Optimal Dietary Fat Pattern to Prevent Cardiovascular Disease Among Type 2 Diabetes
Official Title
Effects of Fatty Acid Composition Ratios of Oral Fatty Loads on the Dynamic Metabolism of Postprandial Lipid and Triglyceride-Rich Lipoproteins in Chinese NIDDM Out-Patients
Study Type
Interventional
2. Study Status
Record Verification Date
April 2007
Overall Recruitment Status
Completed
Study Start Date
January 1998 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
May 1998 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Sun Yat-sen University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Cardiovascular complications are the leading cause of death among type 2 diabetic patients. Postprandial triglyceride-rich lipoproteins (ppTRLs) are atherogenic. Dietary fatty acid quality, that is, dietary fatty acid composition is related to atherogenesis. However, to date, the overall influence of dietary fatty acid compositions on lipids in different subfractions of ppTRLs still remains unknown among Chinese diabetic patients. This paucity of evidence may limit the establishment of optimal recommendation of dietary fatty acid composition for type 2 diabetes. We have 2 hypotheses:
Different dietary fatty acid compositions lead to differential overall responses of lipids in four subfractions of ppTRLs over postprandial 6 h.
One dietary fatty acid composition will be identified as anti-atherogenesis for future study as it can improve atherogenic ppTRLs.
Detailed Description
Atherosclerosis is the leading cause of death and disability among patients with type 2 diabetes mellitus. These patients characteristically have hypertriglyceridemia, high VLDL and low HDL-cholesterol in the fasting status. During day-time hours, most individuals are in a postprandial state and the composition of postprandial lipoproteins may play a more important role on metabolic outcome than fasting levels. Postprandial triglyceride-rich lipoproteins (ppTRLs) are atherogenic, and longer residence time and higher concentrations of chylomicron and VLDL remnants in the circulation are significant predictors of coronary heart disease (CHD). Abnormal postprandial lipemia is highly prevalent in diabetic patients, even in individuals with a normal fasting triglyceride concentration. It has been suggested that diabetes mellitus is associated with decreased catabolism of chylomicron remnants, prolonged residence of chylomicron and VLDL remnants in the circulation. Therefore, a diet with favorable effects on ppTRLs should be useful to prevent atherosclerosis among type 2 diabetes patients.
It is well known that dietary saturated fatty acids (SFA) increase the risk for CHD while monounsaturated fatty acids (MUFA) and polyunsaturated fatty acids (PUFA) decrease the risk for CHD via the modification of fasting lipids. Since all dietary sources of fat are composed of a combination of SFA, MUFA nad PUFA, it is best to characterize dietary fats as ratio of SFA:MUFA:PUFA. In fact, the SFA:MUFA:PUFA ratio in any given region or population is relatively homogeneous due to common food sources, food accessibility, food preparation and processing, dietary culture and tradition. For example, dietary fatty acid compositions (SFA:MUFA:PUFA) obtained directly or derived from existing national/regional reports are: 1:1.7:0.4 in Greece,1:1.0:0.5 in USA, and 1:1.5:1 in the mainland of China. Our research showed that the composition was 1:1.7:1.2 among type 2 diabetic patients in Guangzhou, a city in Southern China(10). To date, the overall influence of dietary fatty acid compositions on lipids in different subfractions of ppTRLs still remains unclear. This paucity of evidence may limit the establishment of optimal recommendation of dietary fatty acid composition for type 2 diabetes.
We designed three fat loads with specific fatty acid composition based on our previous study and current nutrition knowledge, and aimed at elucidating the influence of these dietary fatty acid compositions on the overall response of lipids in ppTRLs over postprandial 6 h.Based on the result, we will identify on one dietary fatty acid compositions, which can improve atherogenic ppTRLs and thus may be recommended for diabetic patients, for future large-scale research.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes Mellitus
Keywords
dietary fatty acid composition, postprandial, triglyceride-rich lipoprotein, type 2 diabetes
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
Single
Allocation
Randomized
Enrollment
30 (false)
8. Arms, Groups, and Interventions
Intervention Type
Behavioral
Intervention Name(s)
Diet
Primary Outcome Measure Information:
Title
Lipids including triglyceride and cholesterol in four subfractions of ppTRLs.
Secondary Outcome Measure Information:
Title
Apolipoproteins including apoB100 and apoA1 in the postprandial plasma
Title
Lipoproteins including high- and low-density lipoproteins in the postprandial plasma
Title
Lipids lipoproteins in the postprandial plasma
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Type 2 diabetes;
Types and doses of antidiabetic agents had been unchanged for four weeks before the postprandial study;
Nonsmokers;
No prior cardiovascular disease, hepatic and renal diseases, or other diseases influencing fat absorption;
No previous history of gastro-enteral surgery;
Dietary fat provided energy less than 35% in last two weeks;
No use of medications or vitamins known to affect plasma lipids;
Ability to hold hypoglycemic drugs on the day of the study until postprandial tests are completed;
Ability to provide verbal informed consent to participate.
Exclusion Criteria:
Females with menstrual cycles
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jun Dai, MD
Organizational Affiliation
Department of Clinical Nutrition, School of Public Health, Sun Yat-sen University, Guangzhou, China
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Clinical Nutrition, School of Public Health, Sun Yat-sen University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510080
Country
China
Facility Name
Department of Endocrinology, The First Hospital, Sun Yat-sen University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510080
Country
China
12. IPD Sharing Statement
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Optimal Dietary Fat Pattern to Prevent Cardiovascular Disease Among Type 2 Diabetes
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