Optimal Dietary Fat Pattern to Prevent Cardiovascular Disease Among Type 2 Diabetes

NCT00467168 | Completed Phase 1 DMC

• 1 other identifier: 522301118
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 2

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:

1. 1.Different dietary fatty acid compositions lead to differential overall responses of lipids in four subfractions of ppTRLs over postprandial 6 h.
2. 2.One dietary fatty acid composition will be identified as anti-atherogenesis for future study as it can improve atherogenic ppTRLs.

Conditions

Type 2 Diabetes Mellitus

Keywords

dietary fatty acid composition; postprandial; triglyceride-rich lipoprotein; type 2 diabetes

Outcome Measures

Primary Outcomes (1)

• Lipids including triglyceride and cholesterol in four subfractions of ppTRLs.

Secondary Outcomes (3)

• 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

Interventions

Diet BEHAVIORAL

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Females with menstrual cycles

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (2)

Department of Clinical Nutrition, School of Public Health, Sun Yat-sen University

Guangzhou, Guangdong, 510080, China

Location

Department of Endocrinology, The First Hospital, Sun Yat-sen University

Guangzhou, Guangdong, 510080, China

Location

Related Publications (21)

• Groot PH, van Stiphout WA, Krauss XH, Jansen H, van Tol A, van Ramshorst E, Chin-On S, Hofman A, Cresswell SR, Havekes L. Postprandial lipoprotein metabolism in normolipidemic men with and without coronary artery disease. Arterioscler Thromb. 1991 May-Jun;11(3):653-62. doi: 10.1161/01.atv.11.3.653.

  PMID: 2029503 BACKGROUND

• Mero N, Syvanne M, Eliasson B, Smith U, Taskinen MR. Postprandial elevation of ApoB-48-containing triglyceride-rich particles and retinyl esters in normolipemic males who smoke. Arterioscler Thromb Vasc Biol. 1997 Oct;17(10):2096-102. doi: 10.1161/01.atv.17.10.2096.

  PMID: 9351377 BACKGROUND

• Chen J, Gao J. The Chinese total diet study in 1990. Part II. Nutrients. J AOAC Int. 1993 Nov-Dec;76(6):1206-13.

  PMID: 8286957 BACKGROUND

• Karpe F, Steiner G, Uffelman K, Olivecrona T, Hamsten A. Postprandial lipoproteins and progression of coronary atherosclerosis. Atherosclerosis. 1994 Mar;106(1):83-97. doi: 10.1016/0021-9150(94)90085-x.

  PMID: 8018110 BACKGROUND

• Karpe F, Steiner G, Olivecrona T, Carlson LA, Hamsten A. Metabolism of triglyceride-rich lipoproteins during alimentary lipemia. J Clin Invest. 1993 Mar;91(3):748-58. doi: 10.1172/JCI116293.

  PMID: 8450056 BACKGROUND

• Karpe F, Tornvall P, Olivecrona T, Steiner G, Carlson LA, Hamsten A. Composition of human low density lipoprotein: effects of postprandial triglyceride-rich lipoproteins, lipoprotein lipase, hepatic lipase and cholesteryl ester transfer protein. Atherosclerosis. 1993 Jan 4;98(1):33-49. doi: 10.1016/0021-9150(93)90221-f.

  PMID: 8457249 BACKGROUND

• Higashi K, Ishikawa T, Shige H, Tomiyasu K, Yoshida H, Ito T, Nakajima K, Yonemura A, Sawada S, Nakamura H. Olive oil increases the magnitude of postprandial chylomicron remnants compared to milk fat and safflower oil. J Am Coll Nutr. 1997 Oct;16(5):429-34. doi: 10.1080/07315724.1997.10718709.

  PMID: 9322191 BACKGROUND

• Heyden S. Polyunsaturated and monounsaturated fatty acids in the diet to prevent coronary heart disease via cholesterol reduction. Ann Nutr Metab. 1994;38(3):117-22. doi: 10.1159/000177801.

  PMID: 7979164 BACKGROUND

• Brouwer CB, de Bruin TW, Jansen H, Erkelens DW. Different clearance of intravenously administered olive oil and soybean-oil emulsions: role of hepatic lipase. Am J Clin Nutr. 1993 Apr;57(4):533-9. doi: 10.1093/ajcn/57.4.533.

  PMID: 8460608 BACKGROUND

• de Bruin TW, Brouwer CB, van Linde-Sibenius Trip M, Jansen H, Erkelens DW. Different postprandial metabolism of olive oil and soybean oil: a possible mechanism of the high-density lipoprotein conserving effect of olive oil. Am J Clin Nutr. 1993 Oct;58(4):477-83. doi: 10.1093/ajcn/58.4.477.

  PMID: 8379502 BACKGROUND

• Levy E, Roy CC, Goldstein R, Bar-On H, Ziv E. Metabolic fate of chylomicrons obtained from rats maintained on diets varying in fatty acid composition. J Am Coll Nutr. 1991 Feb;10(1):69-78. doi: 10.1080/07315724.1991.10718129.

  PMID: 2010582 BACKGROUND

• Bjorkegren J, Packard CJ, Hamsten A, Bedford D, Caslake M, Foster L, Shepherd J, Stewart P, Karpe F. Accumulation of large very low density lipoprotein in plasma during intravenous infusion of a chylomicron-like triglyceride emulsion reflects competition for a common lipolytic pathway. J Lipid Res. 1996 Jan;37(1):76-86.

  PMID: 8820104 BACKGROUND

• Tatami R, Mabuchi H, Ueda K, Ueda R, Haba T, Kametani T, Ito S, Koizumi J, Ohta M, Miyamoto S, Nakayama A, Kanaya H, Oiwake H, Genda A, Takeda R. Intermediate-density lipoprotein and cholesterol-rich very low density lipoprotein in angiographically determined coronary artery disease. Circulation. 1981 Dec;64(6):1174-84. doi: 10.1161/01.cir.64.6.1174.

  PMID: 7296792 BACKGROUND

• Tornvall P, Hamsten A, Carlson LA. Abnormalities of composition and of in vitro lipolysis products of human small very low density lipoproteins in hypertriglyceridemia. Atherosclerosis. 1990 May;82(1-2):125-35. doi: 10.1016/0021-9150(90)90151-8.

  PMID: 2360914 BACKGROUND

• Reardon MF, Nestel PJ, Craig IH, Harper RW. Lipoprotein predictors of the severity of coronary artery disease in men and women. Circulation. 1985 May;71(5):881-8. doi: 10.1161/01.cir.71.5.881.

  PMID: 3986978 BACKGROUND

• Bjorkegren J, Hamsten A, Milne RW, Karpe F. Alterations of VLDL composition during alimentary lipemia. J Lipid Res. 1997 Feb;38(2):301-14.

  PMID: 9162750 BACKGROUND

• Puppione DL, Kunitake ST, Hamilton RL, Phillips ML, Schumaker VN, Davis LD. Characterization of unusual intermediate density lipoproteins. J Lipid Res. 1982 Feb;23(2):283-90.

  PMID: 7077142 BACKGROUND

• Feldman EB, Russell BS, Chen R, Johnson J, Forte T, Clark SB. Dietary saturated fatty acid content affects lymph lipoproteins: studies in the rat. J Lipid Res. 1983 Aug;24(8):967-76.

  PMID: 6631238 BACKGROUND

• Dai J, Su Y, Yan F, Liu S, Xu L, Li J. The pattern of diet and dietary fatty acid in type 2 diabetic out-patients investigated with an accurate food frequency method. J Chinese Public Health. 2000;16(1):43-4.

  RESULT

• Dai J, Su Y, Ling W, Liang Y, Zhong C, Ou X. Study of fatty acids composition ratio of oral fat loads used in postprandial lipids and lipoproteins metabolism. Chinese J Arteriosclerosis. 2000;8(3):8-13.

  RESULT

• Dai J, Su YX, Bartell S, Le NA, Ling WH, Liang YQ, Gao L, Wu HY, Veledar E, Vaccarino V. Beneficial effects of designed dietary fatty acid compositions on lipids in triacylglycerol-rich lipoproteins among Chinese patients with type 2 diabetes mellitus. Metabolism. 2009 Apr;58(4):510-8. doi: 10.1016/j.metabol.2008.11.010.

  PMID: 19303972 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Diet

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Jun Dai, MD

  Department of Clinical Nutrition, School of Public Health, Sun Yat-sen University, Guangzhou, China

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: April 26, 2007
• First Posted: April 27, 2007
• Study Start: January 1, 1998
• Study Completion: May 1, 1998
• Last Updated: April 27, 2007

Record last verified: 2007-04

Locations

CN (2)