- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01224561
Adaptation of Lipid and Energy Metabolism During a Lipid Overnutrition in Constitutional Thinness (Surnutrition)
May 4, 2011 updated by: Centre Hospitalier Universitaire de Saint Etienne
For a given food intake, fat and energy metabolism in adipose tissue and muscle adapt to nutrient intakes.
This adaptation to nutrition may be impaired in susceptible individuals or in obese patients by promoting weight gain, either in constitutional thinness (MC) by blocking it.
The MC is a little known entity.
These patients wish to grow for her and others.
Can they?
We have demonstrated abnormalities of hormones regulating appetite (ghrelin, PYY, GLP1 and leptin) that may participate in thinness.
Furthermore, this thinness is associated with osteoporosis in 25% of true MC who is 25 years old.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
This project aims to overfed MCs and follow the control parameters of energy metabolism.
We will look for abnormalities in the adaptation to overnutrition in subjects with genetic background of thinness, which could explain the resistance to weight gain.
The answer could possibly help to understand obesity.
Study Type
Observational
Enrollment (Anticipated)
26
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, 63000
- CRNH Auvergne
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Lyon, France, 69000
- CRNH Rhone-Alpes
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Saint-etienne, France, 42055
- CHU de Saint-Etienne
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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 35 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Sampling Method
Non-Probability Sample
Study Population
Constitutionnal thinness women and healthy volonteers(women)
Description
Inclusion Criteria:
- consent form the study signed
- consent form for genetic study signed
- normal laboratory values for liver enzymes, glucose, lipid
Exclusion Criteria (common to the two groups):
- pregnant
- vegetarian
- heavy smoking
- heavy alcohol
- depressive
- taking hypolipidemic or antihypertensive drugs
- dyslipidemia
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
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Constitutional thinness
Women with a a body mass index of less than 16.5 kg/m2
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During 4 months, the daily caloric intake will be increased by about 70 g fat as butter 20 grams, 100 grams of cheese (Emmental) and 40 grams of almonds.
This overnutrition corresponds to an excess of 760 kcal / day or 21,280 calories for the period and then taken to a theoretical 2.4 kg of fat (1 kg fat = 9000 kcal).
|
Healthy Volonteer
Women with a body mass index between 20 and 25 kg/m2
|
During 4 months, the daily caloric intake will be increased by about 70 g fat as butter 20 grams, 100 grams of cheese (Emmental) and 40 grams of almonds.
This overnutrition corresponds to an excess of 760 kcal / day or 21,280 calories for the period and then taken to a theoretical 2.4 kg of fat (1 kg fat = 9000 kcal).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
gene expression
Time Frame: After one month of lipid overnutrition
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Level of genes (which regulate the lipid and energy metabolism) expression in fat and muscle tissues
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After one month of lipid overnutrition
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Anthropometric parameter
Time Frame: After one month of lipid overnutrition
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Lean mass
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After one month of lipid overnutrition
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Autonomic nervous system activity
Time Frame: After one month of lipid overnutrition
|
Heart rate variability analyses using ECG Holter monitoring
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After one month of lipid overnutrition
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gastrointestinal hormone level
Time Frame: After one month of lipid overnutrition
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Serum level of GLP1
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After one month of lipid overnutrition
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Anthropometric parameter
Time Frame: After one month of lipid overnutrition
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Weight
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After one month of lipid overnutrition
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Anthropometric parameter
Time Frame: After one month of lipid overnutrition
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Fat mass
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After one month of lipid overnutrition
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gastrointestinal hormone level
Time Frame: After one month of lipid overnutrition
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Serum level of ghréline
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After one month of lipid overnutrition
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gastrointestinal hormone level
Time Frame: After one month of lipid overnutrition
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Serum level of PYY
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After one month of lipid overnutrition
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Bruno ESTOUR, MD PhD, CHU de Saint-Etienne
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
March 1, 2008
Primary Completion (Actual)
January 1, 2011
Study Completion (Actual)
January 1, 2011
Study Registration Dates
First Submitted
October 18, 2010
First Submitted That Met QC Criteria
October 19, 2010
First Posted (Estimate)
October 20, 2010
Study Record Updates
Last Update Posted (Estimate)
May 5, 2011
Last Update Submitted That Met QC Criteria
May 4, 2011
Last Verified
May 1, 2011
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 0701047
- 2007-A00744-49 (Other Identifier: Afssaps)
- DGS2007-0536 (Other Identifier: DGS)
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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