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

Not Applicable

Terminated

• Conditions: Type 2 Diabetes

• Registration Number: NCT00371982
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

Brief Summary

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.

Detailed 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.

Study Timeline

• Status Verified: 2002-11
• Study Start: 2002-12
• Study Completion: 2005-04
• Study First Submitted: 2006-09-01
• Study First Submitted QC: 2006-09-01
• Last Update Submitted: 2006-09-01
• Study First Posted: 2006-09-04
• Last Update Posted: 2006-09-04

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 24

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

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
The effect of 2 month treatment on:
adiposity (total fat mass, adipocyte morphology), atherogenic markers and insulin sensitivity

Secondary Outcome Measures

Name	Time	Method
the underlying mechanisms of the observed results and tried to define new targets of fish oil metabolic effects
and the impact of fish oil on systemic inflammatory markers and adipose tissue inflammatory genes.

Trial Locations

Locations (1)

Department of Diabetes-Hotel Dieu Hospital; 🇫🇷 Paris, France