Effect of Fish Oil on Adiposity and Atherogenic Factors in Type 2 Diabetic Women

Assistance Publique - Hôpitaux de Paris

Status: Terminated

Conditions: Type 2 Diabetes

Treatments: Drug: Fish oil (Maxepa)

Study type: Interventional

Funder types: Other

Identifiers

NCT00371982

INSERM-237-6900, Paris 6-069

Details and patient eligibility

About

1. whether the intake of n-3 PUFA has additional effects on insulin sensitivity and adiposity (total fat mass and adipocyte morphology and function) in T2D women.
2. n-3 PUFA supplementation might influence inflammatory genes expression in the adipose tissue of T2D patients.

Full description

Thus, the present study was designed to evaluate the effects of n-3 PUFAs dietary supplementation on lipid and glucose homeostasis and to address the impact of this treatment on adiposity and adipose tissue gene expression in T2D women.A total of 27 T2D women (BMI 27-35kg/m², age 40-60 y) were randomly allocated to two months of 3 g/day of either fish oil (1.8 g n-3 PUFA) or placebo (paraffin oil), in a double-blind parallel design.

Sex: Female

Ages: 40 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Type 2 diabetic postmenopausal women
2. glycaemia of 7.87-14.0 mmol/l, HbA1c of 7 to 10.5%
3. plasma triglycerides between 1.72-4.6 mmol/l,
4. aged between 40 -60,
5. BMI: 27-40 kg/m2
6. able to swallow tablets

Exclusion criteria

1. patients with abnormal renal, hepatic and thyroid functions as determined by physical examination, blood cell count and standard blood biochemical profile
2. patients with gastrointestinal disorders
3. patients treated with thiazolidinediones or insulin

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind