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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

  • France
      • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Constitutional thinness
Women with a a body mass index of less than 16.5 kg/m2
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).
Healthy Volonteer
Women with a body mass index between 20 and 25 kg/m2
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).

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Centre Hospitalier Universitaire de Saint Etienne

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Ministry of Health, France

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2008

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2011

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2011

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 18, 2010

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 19, 2010

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 20, 2010

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 5, 2011

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 4, 2011

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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