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

This study has been terminated.

First Received: September 1, 2006 No Changes Posted

Sponsors and Collaborators:	Assistance Publique - Hôpitaux de Paris Institut National de la Santé Et de la Recherche Médicale, France
Information provided by:	Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:	NCT00371982

Purpose

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.
n-3 PUFA supplementation might influence inflammatory genes expression in the adipose tissue of T2D patients.

Condition	Intervention
Type 2 Diabetes	Drug: Fish oil (Maxepa)

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study

Resource links provided by NLM:

MedlinePlus related topics: Diabetes Obesity

Drug Information available for: Fish oil

U.S. FDA Resources

Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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.

Estimated Enrollment:	24
Study Start Date:	December 2002
Estimated Study Completion Date:	April 2005

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.

Eligibility

Ages Eligible for Study:	40 Years to 60 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00371982

Locations

France
Department of Diabetes-Hotel Dieu Hospital
Paris, France, 75004

Sponsors and Collaborators

Assistance Publique - Hôpitaux de Paris

Institut National de la Santé Et de la Recherche Médicale, France

Investigators

Study Director:	Salwa W Rizkalla, MD,PhD	INSERM (National institution of Health and Medical Research)
Study Chair:	Gerard Slama, MD, professor	Public Assistance-Paris Hospitals (AP-HP), University Paris 6

More Information

No publications provided

Study ID Numbers:	INSERM-237-6900, Paris 6-069
Study First Received:	September 1, 2006
Last Updated:	September 1, 2006
ClinicalTrials.gov Identifier:	NCT00371982 History of Changes
Health Authority:	France: Institutional Ethical Committee

Keywords provided by Assistance Publique - Hôpitaux de Paris:

Fish oil
Type 2 diabetic women
adiposity

adipose tissue inflammation
PAI-1
Insulin sensitivity

Study placed in the following topic categories:

Obesity
Metabolic Diseases
Diabetes Mellitus, Type 2
Plasminogen Activator Inhibitor 1
Diabetes Mellitus
Endocrine System Diseases

Endocrinopathy
Glucose Metabolism Disorders
Metabolic Disorder
Insulin
Inflammation

Additional relevant MeSH terms:

Metabolic Diseases
Diabetes Mellitus, Type 2
Diabetes Mellitus
Endocrine System Diseases
Glucose Metabolism Disorders

ClinicalTrials.gov processed this record on September 09, 2009