Adaptation of Lipid and Energy Metabolism During a Lipid Overnutrition in Constitutional Thinness (Surnutrition)

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

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

      • Clermont-Ferrand, France, 63000
        • CRNH Auvergne
      • Lyon, France, 69000
        • CRNH Rhone-Alpes
      • Saint-etienne, France, 42055
        • CHU de Saint-Etienne

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
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
Level of genes (which regulate the lipid and energy metabolism) expression in fat and muscle tissues
After one month of lipid overnutrition

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Anthropometric parameter
Time Frame: After one month of lipid overnutrition
Lean mass
After one month of lipid overnutrition
Autonomic nervous system activity
Time Frame: After one month of lipid overnutrition
Heart rate variability analyses using ECG Holter monitoring
After one month of lipid overnutrition
gastrointestinal hormone level
Time Frame: After one month of lipid overnutrition
Serum level of GLP1
After one month of lipid overnutrition
Anthropometric parameter
Time Frame: After one month of lipid overnutrition
Weight
After one month of lipid overnutrition
Anthropometric parameter
Time Frame: After one month of lipid overnutrition
Fat mass
After one month of lipid overnutrition
gastrointestinal hormone level
Time Frame: After one month of lipid overnutrition
Serum level of ghréline
After one month of lipid overnutrition
gastrointestinal hormone level
Time Frame: After one month of lipid overnutrition
Serum level of PYY
After one month of lipid overnutrition

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

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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