NCT00431899

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
8

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2003

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

May 1, 2003

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2003

Completed
3.3 years until next milestone

First Submitted

Initial submission to the registry

February 3, 2007

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 6, 2007

Completed
Last Updated

March 3, 2016

Status Verified

February 1, 2007

First QC Date

February 3, 2007

Last Update Submit

March 2, 2016

Conditions

HemodialysisEnd Stage Renal Disease

Keywords

nutritionomega 3 fatty acidsinsulin resistance

Outcome Measures

Primary Outcomes (2)

  • plasma glucose utilization

  • glucose-induced thermogenesis

Interventions

fish oil supplementationBEHAVIORAL

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • hemodialysis at least 6 months duration end stage renal disease

You may not qualify if:

  • \- 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Laboratoire Régional de Nutrition Humaine

Brest, F-29200, France

Location

MeSH Terms

Conditions

Kidney Failure, ChronicInsulin Resistance

Condition Hierarchy (Ancestors)

Renal Insufficiency, ChronicRenal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Jacques Delarue, MD,PhD

    CHU Cavale Blanche F-29200 Brest

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SCREENING
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 3, 2007

First Posted

February 6, 2007

Study Start

May 1, 2003

Study Completion

November 1, 2003

Last Updated

March 3, 2016

Record last verified: 2007-02

Locations

FR(1)