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Effects of Omega 3 in Hemodialysis Patients

Primary Purpose

Hemodialysis, End Stage Renal Disease

Status

Completed

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

fish oil supplementation

About this trial

This is an interventional screening trial for Hemodialysis focused on measuring nutrition, omega 3 fatty acids, insulin resistance

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

hemodialysis at least 6 months duration end stage renal disease

Exclusion Criteria:

- Age < 18 y ou > 75 y
Hemodialysis < 6 months
Diabetes, obesity
allergy to fish
Asthma
glucocorticoïds, propranolol,, Immunosuppressive drugs, Insulin, Somatostatin
erythropoïetin < 3 months
Cancer
Hemoglobin < 11 g/l
disease < 1 month
pregnancy
respiratory insufficiency
intensive sport practice
refusal

Sites / Locations

Laboratoire Régional de Nutrition Humaine

Outcomes

Primary Outcome Measures

plasma glucose utilization

glucose-induced thermogenesis

Secondary Outcome Measures

Full Information

NCT ID

NCT00431899

First Posted

February 3, 2007

Last Updated

March 2, 2016

Sponsor

Laboratoire Régional de Nutrition Humaine

1. Study Identification

Unique Protocol Identification Number

NCT00431899

Brief Title

Effects of Omega 3 in Hemodialysis Patients

Official Title

Effets of Fish Oil on Metabolic Fate of an Oral Glucose Load in Patients With End Stage Renal Disease Undergoing Hemodialysis

Study Type

Interventional

2. Study Status

Record Verification Date

February 2007

Overall Recruitment Status

Completed

Study Start Date

May 2003 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

November 2003 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

Laboratoire Régional de Nutrition Humaine

4. Oversight

5. Study Description

Brief Summary

The aim of the study was to determine the effects of a 3-week fish oil oral supplementation on the metabolic fate and thermogenic effect of an oral glucose load in hemodialysis patients.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hemodialysis, End Stage Renal Disease

Keywords

nutrition, omega 3 fatty acids, insulin resistance

7. Study Design

Primary Purpose

Screening

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

8 (false)

8. Arms, Groups, and Interventions

Intervention Type

Behavioral

Intervention Name(s)

fish oil supplementation

Primary Outcome Measure Information:

Title

plasma glucose utilization

Title

glucose-induced thermogenesis

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: hemodialysis at least 6 months duration end stage renal disease Exclusion Criteria: - Age < 18 y ou > 75 y Hemodialysis < 6 months Diabetes, obesity allergy to fish Asthma glucocorticoïds, propranolol,, Immunosuppressive drugs, Insulin, Somatostatin erythropoïetin < 3 months Cancer Hemoglobin < 11 g/l disease < 1 month pregnancy respiratory insufficiency intensive sport practice refusal

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jacques Delarue, MD,PhD

Organizational Affiliation

CHU Cavale Blanche F-29200 Brest

Official's Role

Principal Investigator

Facility Information:

Facility Name

Laboratoire Régional de Nutrition Humaine

City

Brest

ZIP/Postal Code

F-29200

Country

France

12. IPD Sharing Statement

Learn more about this trial

Effects of Omega 3 in Hemodialysis Patients

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