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Mediterranean Diet and Postprandial Lipemia

F

Federico II University

Status

Completed

Conditions

Postprandial Lipemia
Type 2 Diabetes

Treatments

Other: Mediterranean diet and Low-Carbohydrates diet

Study type

Interventional

Funder types

Other

Identifiers

NCT00789295
29102008

Details and patient eligibility

About

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).

Sex

All

Ages

40 to 65 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Double Blind

0 participants in 2 patient groups

Mediterranean diet
Active Comparator group
Description:
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%)
Treatment:
Other: Mediterranean diet and Low-Carbohydrates diet
Low-Carbohydrates diet
Active Comparator group
Description:
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%)
Treatment:
Other: Mediterranean diet and Low-Carbohydrates diet

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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