- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01249326
Protein Need and Interest of " Quick Proteins " to the Obese Subject Operated by Bariatric Surgery (BIBOP) (BIBOP)
November 9, 2018 updated by: University Hospital, Clermont-Ferrand
The main objective of the study is to evaluate the protein requirement associated with postoperative weight loss caused by by-pass (shunt which leads to a certain degree of malabsorption) or sleeve gastrectomy (more technically conservative with less malabsorption), through the study of nitrogen balance.
The benefit of protein supply easily absorbed and with high essential amino acids content (proteins "fast" soluble milk) on protein metabolism and muscle function will also be studied.
Endotoxemia and intestinal flora variations were measured before and after bariatric surgery.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
This is a prospective longitudinal study of the effect of bariatric surgery on protein requirements and protein metabolism, and protein supplementation interest, appropriate to the digestive tract changes, for the mass and muscle function.
Three groups of patients will be studied: One group undergoing sleeve gastrectomy in Clermont-Ferrand (group 1: n = 20) will be followed by current recommendations.
A second group undergoing sleeve gastrectomy in Clermont-Ferrand (group 2: n = 20) will receive during three months, protein supplement (powder whey protein ("fast")) at dose of 40g / day. 10 patients in group 1 and 10 patients in group 2 will participate in protein metabolism study.
The third group undergoing gastric bypass in Lyon (group 3: n = 20) will be followed by the current recommendations and will participate in study of endotoxemia.
Study Type
Interventional
Enrollment (Actual)
25
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Clermont-Ferrand, France, 63003
- CHU Clermont-Ferrand
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 60 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Males and females.
- Age between 18 to 60 years.
- Body mass index: BMI> 40 kg/m2,
- Biological Review considered satisfactory by the investigator based on the topics covered
- Serology HIV ( Human Immunodeficiency Virus )and HCV (Hepatitis C Virus ) negative.
- Subject giving his written informed consent
- Affiliated to National Health Insurance
Exclusion Criteria:
- Subject under 18 or over 60 years.
- Balance Organic considered abnormal by the investigator.
- Serology HIV or HCV positive.
- Pregnant or lactating.
- For women of childbearing age: β-HCG assay positive and not having reliable contraceptives (oral contraceptive, IUD (Intrauterine Device), implant or hormone patch, abstinence).
- Medical or surgical history (judged by investigator to be incompatible with the study).
- Subject with unstable psychiatric condition
- Blood donation in the two months preceding the study.
- 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).
- Subjects with an allergy or intolerance to dairy products.
- Intense sporting activity (> 5 hours / week).
- Being in exclusion on the National Volonteers Data file or having perceived more than 4500 Euros in the year for clinical study participation.
- No one under guardianship or not subject to social security.
- Subjects deprived of their liberty by judicial or administrative decision.
- Refusal to sign the information sheet and written consent for participation
- Subject with a cardiovascular or neoplasic evolutive disease
- Subject with a severe infection in the 3 months period before inclusion (assessed by doctor during inclusion consultation)
- Hypercorticism and dysthyroïdism
- Subject with a known neuro-muscular disease
- Subject with a chronic or acute inflammatory disease in the 3 months period before inclusion
- Subject treated by: corticoids, immunosupressor, anabolic agents, growth factor or having stopped treatment for less than 3 months before inclusion.
Furthermore for subjects having undergone a by-pass at Lyon:
- Subject consuming pre or probiotics many times per day, having an impact on intestinal flora.
- Subject with antibiotics during the 3 months before the beginning of the study.
- Subject with an intolerance to dairy products and refusing to consume dairy prod
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
to measure the nitrogen balance and its variation during weight loss
Time Frame: before, after 3 months and 1 year after the operation
|
before, after 3 months and 1 year after the operation
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Protein metabolism of body and muscle will be assessed
Time Frame: before and 3 months after surgery
|
before and 3 months after surgery
|
- Body composition will be assessed using deuterated water (2H2O) ingested and by BIA (Bioelectrical Impedance Analysis )
Time Frame: before, after 3 months and 1 year after surgery
|
before, after 3 months and 1 year after surgery
|
Changes of endotoxemia will be assessed by measuring blood levels of endotoxin, their carriers, inflammatory cytokines, and protein transfer fasting and after a high fat breakfast test
Time Frame: before and 3 months after surgery
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before and 3 months after surgery
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The voluntary muscular force and muscular weariness will be assessed in Clermont-Ferrand and Lyon by Dynatrac measurement apparatus
Time Frame: before, after 3 months and 1 year after the operation
|
before, after 3 months and 1 year after the operation
|
Muscle mass will be estimated by urinary creatinine measurements
Time Frame: before, after 3 months and 1 year after the operation).
|
before, after 3 months and 1 year after the operation).
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Intestinal flora microbiology analysis will be performed
Time Frame: 3 months and 1 year after bariatric surgery
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3 months and 1 year after bariatric surgery
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Daily physical activity will be measured by an Acti-Heart apparatus
Time Frame: before, after 3 months and 1 year after surgery
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before, after 3 months and 1 year after surgery
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- Insulino-resistance will be measured by the HOMA test( test aHomeostatic Model Assessment)and the DISSE index ((Disse E, Diabetes & Metabolism, 2008).
Time Frame: before, after 3 months and 1 year after surgery)
|
before, after 3 months and 1 year after surgery)
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Inflammatory, hormonal, metabolic parameters' variation will be assessed by blood biological and urinary parameters measurement
Time Frame: before, after 3 months and 1 year after surgery).
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before, after 3 months and 1 year after surgery).
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 1, 2010
Primary Completion (Actual)
March 19, 2015
Study Completion (Actual)
March 19, 2015
Study Registration Dates
First Submitted
November 15, 2010
First Submitted That Met QC Criteria
November 25, 2010
First Posted (Estimate)
November 29, 2010
Study Record Updates
Last Update Posted (Actual)
November 13, 2018
Last Update Submitted That Met QC Criteria
November 9, 2018
Last Verified
November 1, 2018
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CHU-0084
- 2009-A01093-54 (Registry Identifier: Afssaps)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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