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

September 1, 2006 updated by: Assistance Publique - Hôpitaux de Paris
  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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment

24

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

38 years to 58 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assistance Publique - Hôpitaux de Paris

Collaborators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2002

Study Completion

April 1, 2005

Study Registration Dates

First Submitted

September 1, 2006

First Submitted That Met QC Criteria

September 1, 2006

First Posted (Estimate)

September 4, 2006

Study Record Updates

Last Update Posted (Estimate)

September 4, 2006

Last Update Submitted That Met QC Criteria

September 1, 2006

Last Verified

November 1, 2002

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • INSERM-237-6900, Paris 6-069

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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