Effect of Fish Oil on Adiposity and Atherogenic Factors i... | NCT00371982

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

NCT00371982

Sponsor

Assistance Publique - Hôpitaux de Paris

Status

Terminated

Last Update Posted

Sep 4, 2006Estimated

Enrollment

Phase

Not Applicable

Conditions

Type 2 Diabetes

Interventions

Fish oil (Maxepa)

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2002

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2002

Primary Completion Date

Not provided

Completion Date

Apr 2005

First Submitted Date

Sep 1, 2006

First Submission Date that Met QC Criteria

Sep 1, 2006

First Posted Date

Sep 4, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 1, 2006

Last Update Posted Date

Sep 4, 2006Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Not provided

Lead Sponsor

Assistance Publique - Hôpitaux de ParisOTHER

Collaborators

Name	Class
Institut National de la Santé Et de la Recherche Médicale, France	OTHER_GOV

Description Module

Brief Summary

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.

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

Name	Type	Description	Arm Group Labels	Other Names
Fish oil (Maxepa)	Drug

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	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.

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

40 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
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

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Diabetes-Hotel Dieu Hospital		Paris		75004	France

Condition Browse Module

MeSH Terms

ID	Term
D003924	Diabetes Mellitus, Type 2
D009765	Obesity
D007333	Insulin Resistance

Ancestor Terms

ID	Term
D003920	Diabetes Mellitus
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

ID	Term
D009821	Oils
D008055	Lipids

ID	Term
D005395	Fish Oils
C045153	Maxepa