NCT01824680

Brief Summary

The primary purpose of this protocol is to assess the hormonal regulation of satiety by an intense exercise before and after a 3 month physical activity program. Hormones assessed are: leptin, grhélin, Cholecystokinin, Glucagon-Like-Peptid-1 (GLP-1), PYY. It is well known that in overweight adults and children also, an intense physical exercise diminish the food intake relatively to the total energy expenditure and this effect is persistent after a 6 weeks physical activity program. Our hypothesis are: a diminution of food intake after the intense physical exercise and a persistent diminution of food intake after the 3 month physical activity program, an augmentation of levels of GLP-1 and PYY during the intense exercise before and after the physical activity program, a diminution of the level of GLP-1 and leptin before and after the physical activity program

Trial Health

33
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Trial recruitment is currently suspended
Enrollment
30

participants targeted

Target at below P25 for not_applicable obesity

Timeline
Completed

Started Oct 2012

Geographic Reach
1 country

1 active site

Status
suspended

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2012

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

February 28, 2013

Completed
1 month until next milestone

First Posted

Study publicly available on registry

April 5, 2013

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2014

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2014

Completed
Last Updated

April 5, 2013

Status Verified

April 1, 2013

Enrollment Period

1.6 years

First QC Date

February 28, 2013

Last Update Submit

April 2, 2013

Conditions

Obesity

Keywords

ObesityAppetite regulationHormonesAdolescentsExercise

Outcome Measures

Primary Outcomes (1)

  • Comparison before and after the physical activity program of the effect of intense exercise on kinetic of secretion of regulation hormones: Leptin, Grhélin, CCK, PYY3-36, GLP-1

    after 3 months of physical activity

Secondary Outcomes (6)

  • Comparison, before and after the physical activity program, of Hunger sensation by Visual Analogic Scales

    after 3 months of physical activity

  • Comparison, before and after the physical activity program of food intake

    after 3 months of physical activity

  • Comparison, before and after the physical activity program of insulinosensibility

    after 3 months of physical activity

  • Comparison, before and after the physical activity program of peripheral blood output

    after 3 months of physical activity

  • Comparison, before and after the physical activity program of sleep quality

    agter 3 months of physical activity

  • +1 more secondary outcomes

Study Arms (1)

obesity

EXPERIMENTAL
Behavioral: Physical activity

Interventions

Physical activityBEHAVIORAL

There is two sequences, one before and one after the physical activity program. Each sequence contains one "rest" session and one "exercise" session

obesity

Eligibility Criteria

Age12 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Overweight adolescents (over the 90 th percentile of the international cut-off point)
  • With a computer and an internet connection
  • Sedentary (according to the IPAQ-A questionnaire)
  • Without eating disorders (according to the DEBQ questionnaire)

You may not qualify if:

  • Medical or surgical antecedents that are incompatible with the study: cardiovascular, endocrine or digestive disease.
  • Drugs that could interfere with the results of the study
  • Surgical intervention in the 3 months
  • Regular consumption of tobacco or Alcohol
  • patients on a diet with caloric restriction
  • Refusal to sign the consent form
  • Regular practice of sport and intensive

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Clermont-Ferrand

Clermont-Ferrand, 63003, France

Location

MeSH Terms

Conditions

ObesityMotor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBehavior

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Etienne MERLIN

    University Hospital, Clermont-Ferrand

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 28, 2013

First Posted

April 5, 2013

Study Start

October 1, 2012

Primary Completion

May 1, 2014

Study Completion

July 1, 2014

Last Updated

April 5, 2013

Record last verified: 2013-04

Locations

FR(1)