Adaptation of Lipid and Energy Metabolism During a Lipid Overnutrition in Constitutional Thinness (Surnutrition)
This study has been completed.
Sponsor:
Centre Hospitalier Universitaire de Saint Etienne
Collaborator:
Ministry of Health, France
Information provided by:
Centre Hospitalier Universitaire de Saint Etienne
ClinicalTrials.gov Identifier:
NCT01224561
First received: October 18, 2010
Last updated: May 4, 2011
Last verified: May 2011
| Tracking Information | |||||
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| First Received Date ICMJE | October 18, 2010 | ||||
| Last Updated Date | May 4, 2011 | ||||
| Start Date ICMJE | March 2008 | ||||
| Primary Completion Date | January 2011 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
gene expression [ Time Frame: After one month of lipid overnutrition ] [ Designated as safety issue: No ] Level of genes (which regulate the lipid and energy metabolism) expression in fat and muscle tissues |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT01224561 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Adaptation of Lipid and Energy Metabolism During a Lipid Overnutrition in Constitutional Thinness | ||||
| Official Title ICMJE | Adaptation of Lipid and Energy Metabolism During a Lipid Overnutrition in Constitutional Thinness | ||||
| Brief Summary | 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. |
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| 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. |
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| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Time Perspective: Prospective | ||||
| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Retention: Samples With DNA Description: muscle tissue fat tissue |
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| Sampling Method | Non-Probability Sample | ||||
| Study Population | Constitutionnal thinness women and healthy volonteers(women) |
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| Condition ICMJE |
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| Intervention ICMJE | Behavioral: Lipid overnutrition
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). |
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| Study Group/Cohort (s) |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Estimated Enrollment ICMJE | 26 | ||||
| Completion Date | January 2011 | ||||
| Primary Completion Date | January 2011 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria (common to the two groups):
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| Gender | Female | ||||
| Ages | 18 Years to 35 Years | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | France | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01224561 | ||||
| Other Study ID Numbers ICMJE | 0701047, 2007-A00744-49, DGS2007-0536 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Clément CAILLAUX, Centre Hospitalier Universitaire de Saint-Etienne | ||||
| Study Sponsor ICMJE | Centre Hospitalier Universitaire de Saint Etienne | ||||
| Collaborators ICMJE | Ministry of Health, France | ||||
| Investigators ICMJE |
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| Information Provided By | Centre Hospitalier Universitaire de Saint Etienne | ||||
| Verification Date | May 2011 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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