Optimal Dietary Fat Pattern to Prevent Cardiovascular Disease Among Type 2 Diabetes
| Tracking Information | |||||
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| First Received Date ICMJE | April 26, 2007 | ||||
| Last Updated Date | April 26, 2007 | ||||
| Start Date ICMJE | January 1998 | ||||
| Primary Completion Date | Not Provided | ||||
| Current Primary Outcome Measures ICMJE |
Lipids including triglyceride and cholesterol in four subfractions of ppTRLs. | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | No Changes Posted | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Optimal Dietary Fat Pattern to Prevent Cardiovascular Disease Among Type 2 Diabetes | ||||
| Official Title ICMJE | 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 | ||||
| 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:
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| 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. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 1 Phase 2 |
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| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Pharmacokinetics/Dynamics Study Intervention Model: Parallel Assignment Masking: Single Blind Primary Purpose: Prevention |
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| Condition ICMJE | Type 2 Diabetes Mellitus | ||||
| Intervention ICMJE | Behavioral: Diet | ||||
| Study Arm (s) | Not Provided | ||||
| Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 30 | ||||
| Completion Date | May 1998 | ||||
| Primary Completion Date | Not Provided | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | Not Provided | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | China | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00467168 | ||||
| Other Study ID Numbers ICMJE | 522301118 | ||||
| Has Data Monitoring Committee | Yes | ||||
| Responsible Party | Not Provided | ||||
| Study Sponsor ICMJE | Sun Yat-sen University | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Sun Yat-sen University | ||||
| Verification Date | April 2007 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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