Clinical trial NCT00789295: Mediterranean Diet and Postprandial Lipemia
Official title: Mediterranean vs. Low-Carbohydrate Diet : Which is the Best Dietary Approach for Treating Postprandial Lipid Abnormalities and Improving Glucose Control in Type 2 Diabetic Patients?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postprandial Lipemia
Type 2 Diabetes
Keywords: Mediterranean diet
Postprandial lipids
Postprandial glucose
High fibre diet
Low- CHO diet
High MUFA diet
Dietary approach
Lead sponsor: Federico II University
Sponsor class: OTHER
First posted: 2008-11-11
Sex: ALL
Minimum age (years): 40
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The aim of this intervention study was to evaluate in type 2 diabetic patients the effects on postprandial lipemia and other metabolic parameters (in both everyday life conditions and after a standard test meal) of two diets, one moderately rich in CHO, rich in fibre and with a low glycemic index (Mediterranean diet), and the other low in CHO and rich in MUFA (Low-CHO diet).Since adipose tissue, mainly through its lipolytic activities, is considered as having a pivotal role in the regulation of postprandial lipid metabolism, a further aim of our study was to clarify the role of adipose tissue in modulating the postprandial lipid response induced by the two dietary approaches by evaluating the activities of lipoprotein lipase (LPL) and hormone-sensitive lipase (HSL).


Eligibility criteria: Inclusion Criteria:

* Type 2 diabetes
* Stable metabolic control (HbA1c\<8.0%) on diet or diet alone or diet+metformin
* BMI\<30 kg/m2 and body weight stable during the last six months.
* Both sexes; only post-menopausal women.
* Normal fasting lipid levels
* No use of hypolipidemic drugs

Exclusion Criteria:

* Patient with renal (serum creatinine \>1.5 mg/dl) or hepatic (serum transaminases \>three times upper normal values) impairment.
* Patients with history of cardiovascular disease.
* Pre-menopausal women.
* Any other acute or chronic degenerative disease.
* Anemia (Hb\<12 g/dl).
* Uncontrolled blood pressure.
* Use of any drugs able to interfere with the study medications

Primary outcomes:
measure: Postprandial response triglyceride of chylomicrons and large VLDL
timeFrame: 4 weeks
Secondary outcomes:
measure: Blood glucose and insulin response to test meal
timeFrame: 4 weeks
measure: Lipolytic activities
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Naples
country: Italy
facility: Department of Clinical and Experimental Medicine, Federico II University Hospital,
Study officials:
affiliation: Department of Clinical and Experimental Medicine, Federico II University Hospital, Naples, Italy
name: Gabriele Riccardi, Prof
role: STUDY_CHAIR
References:
citation: Rivellese AA, De Natale C, Di Marino L, Patti L, Iovine C, Coppola S, Del Prato S, Riccardi G, Annuzzi G. Exogenous and endogenous postprandial lipid abnormalities in type 2 diabetic patients with optimal blood glucose control and optimal fasting triglyceride levels. J Clin Endocrinol Metab. 2004 May;89(5):2153-9. doi: 10.1210/jc.2003-031764.
citation: Lopez-Miranda J, Williams C, Lairon D. Dietary, physiological, genetic and pathological influences on postprandial lipid metabolism. Br J Nutr. 2007 Sep;98(3):458-73. doi: 10.1017/S000711450774268X.
citation: Lairon D, Play B, Jourdheuil-Rahmani D. Digestible and indigestible carbohydrates: interactions with postprandial lipid metabolism. J Nutr Biochem. 2007 Apr;18(4):217-27. doi: 10.1016/j.jnutbio.2006.08.001. Epub 2006 Oct 31.
citation: De Natale C, Annuzzi G, Bozzetto L, Mazzarella R, Costabile G, Ciano O, Riccardi G, Rivellese AA. Effects of a plant-based high-carbohydrate/high-fiber diet versus high-monounsaturated fat/low-carbohydrate diet on postprandial lipids in type 2 diabetic patients. Diabetes Care. 2009 Dec;32(12):2168-73. doi: 10.2337/dc09-0266. Epub 2009 Sep 9.