NCT03347305

Brief Summary

The daily energy expenditure of patients treated with peritoneal dialysis could be increased compared to the general population and promote the development of a state of undernutrition. Conversely, the absorption of glucose by transperitoneal route could contribute to the occurrence of a metabolic syndrome. The main objective is to compare DE and its variations according to the conditions (rest, sleep, meals, physical activity) in patients treated with automated DP compared to controls, in a calorimetric chamber.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

August 1, 2016

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

November 15, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 20, 2017

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2019

Completed
Last Updated

February 4, 2019

Status Verified

February 1, 2019

Enrollment Period

3.4 years

First QC Date

November 15, 2017

Last Update Submit

February 1, 2019

Conditions

Renal Failure

Keywords

Energy expenditurePeritoneal dialysis

Outcome Measures

Primary Outcomes (1)

  • Energy expenditure measured by indirect calorimetry in a calorimetric chamber

    Energy expenditure measured by indirect calorimetry in a calorimetric chamber

    at day 1

Secondary Outcomes (3)

  • respiratory quotient (RQ)

    at day1

  • Actimetry

    at day 1

  • HGPO

    at day 1

Study Arms (2)

Patients Group DPA

EXPERIMENTAL

The main objective is to compare DE and its variations according to the conditions (rest, sleep, meals, physical activity) in patients treated with automated DP compared to controls, in a calorimetric chamber

Behavioral: automated DP

Healthy Volunteers

EXPERIMENTAL

The main objective is to compare DE and its variations according to the conditions (rest, sleep, meals, physical activity) in patients treated with automated DP compared to controls, in a calorimetric chamber

Behavioral: Calorimetric chamber

Interventions

automated DPBEHAVIORAL

Energy expenditure measurement

Patients Group DPA
Calorimetric chamberBEHAVIORAL

The main objective is to compare DE and its variations according to the conditions (rest, sleep, meals, physical activity) in patients treated with automated DP compared to controls, in a calorimetric chamber

Healthy Volunteers

Eligibility Criteria

Age18 Years - 70 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients Group DPA
  • Male patients
  • Aged 18 to 70 years
  • With end-stage renal disease
  • Treated by automatic peritoneal
  • Social security cover
  • PCR \< 30 mg/L
  • Written informed consent
  • Baecke activity score from 5 to 10
  • Healthy Volunteers
  • Male patients
  • Aged 18 to 70 years
  • Patients matched by lean body mass (± 2 kgs) and age (± 5 years)
  • Having a glomerular filtration rate estimated with the formula CKD-EPI creatinine \> 60 mL / min / 1.73 m 2
  • PCR \< 3 mg/L
  • +3 more criteria

You may not qualify if:

  • - Female
  • Type 1 or 2 diabetes requiring a antidiabetic treatment
  • Decompensated heart failure
  • Smoking more than 5 cigarettes a day
  • Alcoholic patients, drinking more than 3 glass of alcohol a day
  • Patient Corticotherapy in progress
  • Patient with evolutive acute pathology

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Clermont-Ferrand

Clermont-Ferrand, 63003, France

RECRUITING

MeSH Terms

Conditions

Renal Insufficiency

Condition Hierarchy (Ancestors)

Kidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Study Officials

  • Julien ANIORT

    University Hospital, Clermont-Ferrand

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Patrick LACARIN

CONTACT

0473751195placarin@chu-clermontferrand.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Masking Details
No masking
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 15, 2017

First Posted

November 20, 2017

Study Start

August 1, 2016

Primary Completion

December 31, 2019

Study Completion

December 31, 2019

Last Updated

February 4, 2019

Record last verified: 2019-02

Locations

FR(1)