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Completed

NCT Number: NCT00789295

Mediterranean Diet and Postprandial Lipemia

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).

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Key information

Conditions

Postprandial Lipemia Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases Type 2 Diabetes

Age range

40 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Clinical and Experimental Medicine, Federico II University Hospital,

Naples, 80100, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mediterranean diet and Low-Carbohydrates diet

Other

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

Primary outcomes

  1. Postprandial response triglyceride of chylomicrons and large VLDL

    Time frame: 4 weeks

Secondary outcomes

  1. Blood glucose and insulin response to test meal

    Time frame: 4 weeks

  2. Lipolytic activities

    Time frame: 4 weeks

Sponsors and collaborators

Lead sponsor

Federico II University

Other

Registry information

Official study 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?

Important dates

Study start
2004
First posted
Nov 11, 2008
Registry last updated
Nov 11, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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