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

Type 2 Diabetes Clinical Trial

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00371982
• Other study ID #: INSERM-237-6900, Paris 6-069
• Status: Terminated
• Phase: N/A
• First received: September 1, 2006
• Last updated: September 1, 2006
• Start date: December 2002
• Est. completion date: April 2005

Study information

• Verified date: November 2002
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Institutional Ethical Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 24
• Est. completion date: April 2005
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 40 Years to 60 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Type 2 Diabetes

Intervention

Drug:
• Fish oil (Maxepa)

Locations

Country	Name	City	State
France	Department of Diabetes-Hotel Dieu Hospital	Paris

Sponsors (2)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris	Institut National de la Santé Et de la Recherche Médicale, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The effect of 2 month treatment on:
Primary	adiposity (total fat mass, adipocyte morphology), atherogenic markers and insulin sensitivity
Secondary	the underlying mechanisms of the observed results and tried to define new targets of fish oil metabolic effects
Secondary	and the impact of fish oil on systemic inflammatory markers and adipose tissue inflammatory genes.