Mediterranean Diet and Postprandial Lipemia

Type 2 Diabetes Clinical Trial

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?

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00789295
• Other study ID #: 29102008
• Status: Completed
• Phase: N/A
• First received: November 10, 2008
• Last updated: November 10, 2008
• Start date: March 2004

Study information

• Verified date: October 2008
• Source: Federico II University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Postprandial Lipemia
• Type 2 Diabetes

Intervention

Other:
• Mediterranean diet and Low-Carbohydrates diet
The Mediterranean diet: relatively rich in Carbohydrate(52% of the total daily energy intake), rich in dietary fibre (28g/1000 kcal both of soluble and unsoluble types) and with a low glycemic index (51%) versus Low-carbohydrates diet : diet rich in MUFA (23%), relatively low in CHO (45%), low in dietary fibre (8g/1000 kcal) and with a relatively high glycemic index (87%)for 4 weeks

Locations

Country	Name	City	State
Italy	Department of Clinical and Experimental Medicine, Federico II University Hospital,	Naples

Sponsors (1)

Lead Sponsor	Collaborator
Federico II University

Country where clinical trial is conducted

Italy, 

References & Publications (3)

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. Epub 2006 Oct 31. Review. — View 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. Review. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postprandial response triglyceride of chylomicrons and large VLDL		4 weeks
Secondary	Blood glucose and insulin response to test meal		4 weeks	No
Secondary	Lipolytic activities		4 weeks	No