- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01800851
Calorimetry, Insulin Resistance and Energy Metabolism Study to Understand the Risk of Obesity in Kidney Transplanted Patients (CALIMERO)
4. juli 2014 opdateret af: University Hospital, Clermont-Ferrand
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.
Studieoversigt
Status
Afsluttet
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
30
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Clermont-Ferrand, Frankrig, 63003
- CHU clermont-ferrand
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
35 år til 65 år (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ja
Køn, der er berettiget til at studere
Han
Beskrivelse
Inclusion Criteria:
- 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.
- Increase in body weight of at least 3kg during the two years prior to the inclusion of 10 patients. Stable or increasing weight less than 1kg for 10 other patients.
- HIV and HCV serology negative
Exclusion Criteria:
- Female patients
- Diabetic (type 1 or type 2) before transplantation or patients who developed diabetes after transplantation and requiring anti-diabetic treatment at the time of inclusion
- 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
- Patient with an infection 3 months before inclusion
- Subjects infected with hepatitis B, hepatitis C virus or human immunodeficiency
- Patient with acute rejection within 3 months prior to inclusion
- Patient not treated by anticalcineurin
- Patient with a modification of immunosuppressive therapy within 3 months prior to inclusion
- 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
- Patient with acute renal failure defined by a 25% increase in creatinine within 3 months prior to inclusion
- Person under guardianship or not subject to social security
- Person in period Exclusion File National Healthy Volunteers
- Person who refuses to give his written consent to participation
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Tildeling: Randomiseret
- Interventionel model: Crossover opgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Eksperimentel: no weight gain
The characteristics of the renal transplant patients are compared with those of 10 healthy volunteers matched for age and lean body mass
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Eksperimentel: weight gain
The characteristics of the renal transplant patients are compared with those of 10 healthy volunteers matched for age and lean body mass
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Andet: lean body mass
The characteristics of the renal transplant patients are compared with those of 10 healthy volunteers matched for age and lean body mass
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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Energy expenditure
Tidsramme: at day 1
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at day 1
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Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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Body composition
Tidsramme: at day 1
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at day 1
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Food intake
Tidsramme: at day 1
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at day 1
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Estimation of physical activity
Tidsramme: at day 1
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at day 1
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Insulin resistance
Tidsramme: at day 1
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at day 1
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Anne-Elisabeth HENG, University Hospital, Clermont-Ferrand
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. januar 2008
Primær færdiggørelse (Faktiske)
1. december 2012
Studieafslutning (Faktiske)
1. december 2012
Datoer for studieregistrering
Først indsendt
15. februar 2013
Først indsendt, der opfyldte QC-kriterier
26. februar 2013
Først opslået (Skøn)
28. februar 2013
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
8. juli 2014
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
4. juli 2014
Sidst verificeret
1. juli 2014
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- CHU-0146
- 2007-A00287-46
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .