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

Status

Terminated

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00371982

Enrollment

Registered

2006-09-04

Start date

2002-12-31

Completion date

2005-04-30

Last updated

2006-09-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 Diabetes

Keywords

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

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.

Interventions

DRUGFish oil (Maxepa)

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

FEMALE

Age

40 Years to 60 Years

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

Design outcomes

Primary

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

Secondary

Measure	Time frame
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.	—

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026