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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-12-31

Study Completion Date

2005-04-30

Brief Summary

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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

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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.

Conditions

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Type 2 Diabetes

Keywords

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Fish oil Type 2 diabetic women adiposity adipose tissue inflammation PAI-1 Insulin sensitivity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Fish oil (Maxepa)

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

40 Years

Maximum Eligible Age

60 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Principal Investigators

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Salwa W Rizkalla, MD,PhD

Role: STUDY_DIRECTOR

INSERM (National institution of Health and Medical Research)

Gerard Slama, MD, professor

Role: STUDY_CHAIR

Public Assistance-Paris Hospitals (AP-HP), University Paris 6

Locations

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Department of Diabetes-Hotel Dieu Hospital

Paris, , France

Site Status

Countries

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France

Other Identifiers

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INSERM-237-6900, Paris 6-069

Identifier Type: -

Identifier Source: org_study_id