NCT00371982

Brief Summary

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

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for not_applicable type-2-diabetes

Timeline
Completed

Started Dec 2002

Typical duration for not_applicable type-2-diabetes

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2002

Completed
2.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2005

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

September 1, 2006

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 4, 2006

Completed
Last Updated

September 4, 2006

Status Verified

November 1, 2002

First QC Date

September 1, 2006

Last Update Submit

September 1, 2006

Conditions

Type 2 Diabetes

Keywords

Fish oilType 2 diabetic womenadiposityadipose tissue inflammationPAI-1Insulin sensitivity

Outcome Measures

Primary Outcomes (2)

  • The effect of 2 month treatment on:

  • adiposity (total fat mass, adipocyte morphology), atherogenic markers and insulin sensitivity

Secondary Outcomes (2)

  • 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.

Interventions

Fish oil (Maxepa)DRUG

Eligibility Criteria

Age40 Years - 60 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Diabetes-Hotel Dieu Hospital

Paris, 75004, France

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2ObesityInsulin Resistance

Interventions

Fish OilsMaxepa

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesOverweightOvernutritionNutrition DisordersBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsHyperinsulinism

Intervention Hierarchy (Ancestors)

OilsLipids

Study Officials

  • Salwa W Rizkalla, MD,PhD

    INSERM (National institution of Health and Medical Research)

    STUDY DIRECTOR

  • Gerard Slama, MD, professor

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

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 1, 2006

First Posted

September 4, 2006

Study Start

December 1, 2002

Study Completion

April 1, 2005

Last Updated

September 4, 2006

Record last verified: 2002-11

Locations

FR(1)