NCT01800851

Brief Summary

Weight gain is a common complication after transplantation. It has adverse effects such as hypertension, dyslipidemia, and insulin resistance. Weight gain is implicated in the increased cardiovascular risk and the long-term loss of graft function. Weight loss achieved by a suitable dietary intervention in these patients transplanted kidney can correct lipid disorders and facilitate balance blood pressure. The identification of mechanisms responsible for weight gain would suggest prevention strategies and allow to align the caloric energy needs of renal transplant patients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2008

Longer than P75 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

January 1, 2008

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

February 15, 2013

Completed
13 days until next milestone

First Posted

Study publicly available on registry

February 28, 2013

Completed
Last Updated

July 8, 2014

Status Verified

July 1, 2014

Enrollment Period

4.9 years

First QC Date

February 15, 2013

Last Update Submit

July 4, 2014

Conditions

Chronic Renal FailureKidney TransplantationWeight GainInsulin ResistanceDiabetes

Keywords

Kidney transplantationEnergy expenditureWeight gainInsulin resistance

Outcome Measures

Primary Outcomes (1)

  • Energy expenditure

    at day 1

Secondary Outcomes (4)

  • Body composition

    at day 1

  • Food intake

    at day 1

  • Estimation of physical activity

    at day 1

  • Insulin resistance

    at day 1

Study Arms (3)

no weight gain

EXPERIMENTAL

The characteristics of the renal transplant patients are compared with those of 10 healthy volunteers matched for age and lean body mass

Other: Energy expenditure evaluation in calorimetric chamber

weight gain

EXPERIMENTAL

The characteristics of the renal transplant patients are compared with those of 10 healthy volunteers matched for age and lean body mass

Other: Energy expenditure evaluation in calorimetric chamber

lean body mass

OTHER

The characteristics of the renal transplant patients are compared with those of 10 healthy volunteers matched for age and lean body mass

Other: Energy expenditure evaluation in calorimetric chamber

Interventions

Energy expenditure evaluation in calorimetric chamberOTHER
lean body massno weight gainweight gain

Eligibility Criteria

Age35 Years - 65 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male patient, affiliated to a social security system
  • Aged 35 to 65 years
  • Renal transplant for more than a year and less than 6 years
  • Treated by anticalcineurin
  • Patient stopped all treatment with corticosteroids for more than 3 months
  • Patient with stable renal function defined by a calculated creatinine clearance between 30 and 90 mL/min/1, 73m according to the Cockcroft and Gault
  • Written informed consent after detailed explanation of the protocol.
  • HIV and HCV serology negative

You may not qualify if:

  • Female patients
  • Obese patient at the time of transplantation, as defined by a body mass index\> 30%
  • Multiple kidney transplant or other organ transplant the kidney
  • Patient with lower limb edema, congestive heart failure, and/or uncontrolled hypertension.
  • Patient with a change in body weight\> 3 kg in the last 3 months
  • Subjects infected with hepatitis B, hepatitis C virus or human immunodeficiency
  • Patient not treated by anticalcineurin
  • Patient with unstable psychiatric condition
  • Patient smoking\> 5 cigarettes / day
  • Alcoholic patient (unweaned)
  • Patient with stage 4 renal failure (\<30 mL/min/1, 73m ²) and stage 5 (\<15 mL/min/1, 73m ²)
  • hemodialysis patient
  • Person under guardianship or not subject to social security
  • Person who refuses to give his written consent to participation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Clermont-Ferrand

Clermont-Ferrand, 63003, France

Location

MeSH Terms

Conditions

Kidney Failure, ChronicWeight GainInsulin ResistanceDiabetes Mellitus

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 SymptomsBody Weight ChangesBody WeightSigns and SymptomsHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Anne-Elisabeth HENG

    University Hospital, Clermont-Ferrand

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 15, 2013

First Posted

February 28, 2013

Study Start

January 1, 2008

Primary Completion

December 1, 2012

Study Completion

December 1, 2012

Last Updated

July 8, 2014

Record last verified: 2014-07

Locations

FR(1)