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

This study has been terminated.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00371982
First Posted: September 4, 2006
Last Update Posted: September 4, 2006
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Institut National de la Santé Et de la Recherche Médicale, France
Information provided by:
Assistance Publique - Hôpitaux de Paris
  Purpose
  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.

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

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment

Resource links provided by NLM:


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

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

ClinicalTrials.gov Identifier: NCT00371982     History of Changes
Other Study ID Numbers: INSERM-237-6900, Paris 6-069
First Submitted: September 1, 2006
First Posted: September 4, 2006
Last Update Posted: September 4, 2006
Last Verified: November 2002

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Fish oil
Type 2 diabetic women
adiposity
adipose tissue inflammation
PAI-1
Insulin sensitivity