Hemodialysis PatientsIPODNCT01114789
Impact on the Proteolysis of Obesity in Dialysis
A study testing Proteolysis in people with Hemodialysis Patients, run by University Hospital, Clermont-Ferrand at 1 site in France.
Trial summary
The objective of this study is to determine whether obesity has a protective effect on muscle proteolysis in hemodialysis patients submitted to a short starvation. This effect will be tested by comparing measuring muscle proteolysis, using regional infusion of a tracer amino acid (D5 phenylalanine) in two groups of… Read more about this study
- Who is it for?
- Ages 30 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Hemodialysis Patients
- What is being tested?
- Proteolysis
- How many people
- 40 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2011to Mar 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Common Criteria for patients and healthy volunteers:
- Males and females.
- Age between 30 to 70 years.
- Body Mass Index:
- Selection criteria for the obese: BMI> 30 kg/m2, Selection criteria for non-obese subjects: 18.5 <BMI <25 kg/m2.
- Biological Review considered satisfactory by the investigator based on the topics covered: chronic renal (obese or not) or healthy volunteers.
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- Serology HIV and HCV negative.
- Subject giving his written informed consent
- Affiliated to National Health Insurance
- Specific criteria for kidney chronic patients in hemodialysis:
- Patients on hemodialysis since more than 6 months.
- Patients with a clinical stable condition defined by the absence of progressive disease.
- Specific criteria for healthy volunteers:
- Subject considered as healthy after clinical examination and medical questionnaire
- Topic willing to be included in the national register of healthy volunteers.
Who cannot join
- Common Criteria for patients and healthy volunteers:
- Subject under 30 or over 70 years.
- Pregnant or lactating.
- For women of childbearing age: β-hCG assay positive and not have to contraceptives reliable (oral contraceptive, IUD, implant or hormone patch).
- Medical or surgical history (judged by the investigator to be incompatible with the study).
- Diabetics (type 1 or 2).
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- Blood donation in the two months preceding the study.
- Special dietary needs (vegetarian, vegan, ...).
- Heavy alcohol consumption (> 2 to 3 glasses per day depending on sex) or presence of an addiction.
- Tobacco significant (> 5 cigarettes / day or equivalent in cigars or pipe tobacco).
- Intense sporting activity (> 5 hours / week).
- Being in exclusion on the National Volunteers Data file
- Subjects deprived of their liberty by judicial or administrative.
- Specific criteria for kidney chronic patients in hemodialysis:
- Patients treated with peritoneal dialysis.
- Patients treated with daily hemodialysis.
- Albuminemia <35 g / l and transthyrétinémie <300 mg / l
- Specific criteria for healthy volunteers:
- Refusal to be registered on the National Volunteers Data file
- Currently participating or who having got 4500€ in this year before to have participed in another clinical trial
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
CHU Clermont-Ferrand
Clermont-Ferrand, 63003
Patrick LACARIN, 04 73 75 11 95, placarin@chu-clermontferrand.fr
About this study
The objective of this study is to determine whether obesity has a protective effect on muscle proteolysis in hemodialysis patients submitted to a short starvation. This effect will be tested by comparing measuring muscle proteolysis, using regional infusion of a tracer amino acid (D5 phenylalanine) in two groups of obese and non-obese patients compared to obese and non-obese control subjects.
Read the detailed description
In hemodialysis patients, the risk of death decreases almost linearly as BMI increases, including in obese patients. Experimental data suggest that obesity may be associated with a reduction of muscle proteolysis during fasting.
In the hemodialysis patients, after an overnight fast an increased use of endogenous energy stores has been reported. The objective of the study is to evaluate the potentially "protective" effect of obesity on protein catabolism during short fasting periods.
Twenty non diabetic patients (men and women) on maintenance hemodialysis for more than six months, aged of 30 to 70 years, will be included: 10 obese (BMI ≥ 30) and 10 non obese patients (18.5 <BMI <25) will be compared with 20 healthy volunteers (men and women) aged 30 to 70 years, obese and non obese, according to the same criteria.
On the investigation day, tracer kinetic studies will be associated with resting energy expenditure measurements and body composition analysis (using dual energy x-ray absorptiometry (DXA).
- Conditions
- Hemodialysis Patients
- Being tested
- Proteolysis
- Keywords
- chronic renal failure, hemodialysis, obesity, proteolysis
- Medical subject headings
- Kidney Failure, Chronic, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ProteolysisOther
protocol designed to examine the effect of obesity on muscle proteolysis in hemodialysis and control
What is being measured
The primary outcome is the main question the study is designed to answer.
Fasting muscle protein kinetics will be assessed by the isotope dilution technique using D5 phenylalanine. The isotopic plasma enrichment in phenylalanine will be measured after collection of arterialized and venous blood of the forearm.
Measured: 9h to 13h the day of the investigation
Secondary outcomes (3)
Whole-body protein metabolism will be assessed after 13C-leucine infusion in order to determine proteolysis, protein synthesis and protein balance,
Measured: 9h to 13h the day of the investigation
Resting energy metabolism will be measured by indirect calorimetry.
Measured: 10h to 11h and 12h to 12h40 the day of the investigation
Lipid metabolism will be investigated by measuring the participation of energy substrates to the energy expenditure, determination of plasma free fatty acids and calculation of VLDL synthesis rates (measuring the isotopic enrichment of apo B100).
Measured: the day of the investigation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2010 (estimated)
- Study startJan 2011
- Primary completionDec 2012 (estimated)
- Study completionMar 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hemodialysis PatientsStudies of the same condition, open and under way.
- More trials run by University Hospital, Clermont-FerrandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Collaborators
- Centre de Recherche en Nutrition Humaine d'Auvergne, Centre Hospitalier de Vichy, AURA Auvergne Dialyse (Association pour l'Utilisation du Rein Artificiel Auvergne)
- Investigators
- Yves BOIRIE, PUPH, Principal investigator, CHU Clermont-Ferrand (CRNH)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01114789
- Sponsor's protocol ID
- CHU-0071
- Other IDs
- 2008-A00729-46
- Acronym
- IPOD
- Status last verified
- Jan 2011
- First submitted
- 30 Apr 2010
- Last updated
- 26 Jan 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact on the Proteolysis of Obesity in Dialysis
- ClinicalTrials.gov ID
- NCT01114789
- Acronym / sponsor ID
- IPOD / CHU-0071
- Conditions
- Hemodialysis Patients
- Keywords
- chronic renal failure, hemodialysis, obesity, proteolysis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Collaborators
- Centre de Recherche en Nutrition Humaine d'Auvergne, Centre Hospitalier de Vichy, AURA Auvergne Dialyse (Association pour l'Utilisation du Rein Artificiel Auvergne)
- Study start
- Jan 2011
- Primary completion
- Dec 2012 (estimated)
- Study completion
- Mar 2013 (estimated)
- First posted
- 3 May 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this study is to determine whether obesity has a protective effect on muscle proteolysis in hemodialysis patients submitted to a short starvation. This effect will be tested by comparing measuring muscle proteolysis, using regional infusion of a tracer amino acid (D5 phenylalanine) in two groups of obese and non-obese patients compared to obese and non-obese control subjects.
Detailed description
In hemodialysis patients, the risk of death decreases almost linearly as BMI increases, including in obese patients. Experimental data suggest that obesity may be associated with a reduction of muscle proteolysis during fasting.
In the hemodialysis patients, after an overnight fast an increased use of endogenous energy stores has been reported. The objective of the study is to evaluate the potentially "protective" effect of obesity on protein catabolism during short fasting periods.
Twenty non diabetic patients (men and women) on maintenance hemodialysis for more than six months, aged of 30 to 70 years, will be included: 10 obese (BMI ≥ 30) and 10 non obese patients (18.5 <BMI <25) will be compared with 20 healthy volunteers (men and women) aged 30 to 70 years, obese and non obese, according to the same criteria.
On the investigation day, tracer kinetic studies will be associated with resting energy expenditure measurements and body composition analysis (using dual energy x-ray absorptiometry (DXA).
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 30 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Common Criteria for patients and healthy volunteers:
- Males and females.
- Age between 30 to 70 years.
- Body Mass Index:
- Selection criteria for the obese: BMI> 30 kg/m2, Selection criteria for non-obese subjects: 18.5 <BMI <25 kg/m2.
Key exclusion criteria (20 listed)
- Common Criteria for patients and healthy volunteers:
- Subject under 30 or over 70 years.
- Pregnant or lactating.
- For women of childbearing age: β-hCG assay positive and not have to contraceptives reliable (oral contraceptive, IUD, implant or hormone patch).
- Medical or surgical history (judged by the investigator to be incompatible with the study).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Proteolysisprotocol designed to examine the effect of obesity on muscle proteolysis in hemodialysis and control | Other | – |
Primary outcome
Fasting muscle protein kinetics will be assessed by the isotope dilution technique using D5 phenylalanine. The isotopic plasma enrichment in phenylalanine will be measured after collection of arterialized and venous blood of the forearm.
Time frame: 9h to 13h the day of the investigation
3 secondary outcomes
Whole-body protein metabolism will be assessed after 13C-leucine infusion in order to determine proteolysis, protein synthesis and protein balance,
Time frame: 9h to 13h the day of the investigation
Resting energy metabolism will be measured by indirect calorimetry.
Time frame: 10h to 11h and 12h to 12h40 the day of the investigation
Lipid metabolism will be investigated by measuring the participation of energy substrates to the energy expenditure, determination of plasma free fatty acids and calculation of VLDL synthesis rates (measuring the isotopic enrichment of apo B100).
Time frame: the day of the investigation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yves BOIRIE, PUPH principal investigator
CHU Clermont-Ferrand (CRNH)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Proteolysis in people with Hemodialysis Patients, run by University Hospital, Clermont-Ferrand at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Jan 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Patrick LACARIN (04 73 75 11 95, placarin@chu-clermontferrand.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fasting muscle protein kinetics will be assessed by the isotope dilution technique using D5 phenylalanine. The isotopic plasma enrichment in phenylalanine will be measured after collection of arterialized and venous blood of the forearm. (time frame: 9h to 13h the day of the investigation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jan 2011.