ObesityAPHRONCT01824680
Effect of a Physical Activity Program on the Hormonal Regulation of Food Intake
A study testing Physical activity in people with Obesity, run by University Hospital, Clermont-Ferrand at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 to 18 years
- Conditions the study is for
- Obesity
- What is being tested?
- Physical activity
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- Oct 2012to Jul 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of a 3 Months Physical Activity Program on the Hormonal Regulation of Food Intake by Intense Physical Activity in Overweight Adolescents
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
Read the detailed description
There is two sequences, one before and one after the physical activity program. Each sequence contains one "rest" session and one "exercise" session.
Each session contains : blood sample at regular interval (Leptin, Ghrélin, CCK, PYY, GLP-1), a sleeping assessment (Pittsburg scale), an assessment of hunger sensations at regular interval, an assessment of food intake in a "ad libitum" lunch and in the diner indirectly by the SU.VI.MAX. tool.
During the " rest " session :
Blood samples, assessment of hunger sensation, assessment of food intake are realized during the morning. Physical condition (VO2 max, DEXA, and muscular test), insulin-sensibility, lipid profile, are also assessed.
During the "exercise" session: it is identical to the first session but an intense exercise of 40 minutes is realized at 70% of the patient's VO2 max. The peripherical blood output is measured by a non-invasive method: the Near-Infra-Red-Spectroscopy, during the exercise.
The 3-months-physical activity program : there is 4 sessions of 30 minutes and 2 sessions of 1 hour per week. Most of exercises sessions are realized at home but one 1-hour session per week is controled with a sports educator.
- Conditions
- Obesity
- Being tested
- Physical activity
- Keywords
- Obesity, Appetite regulation, Hormones, Adolescents, Exercise
- Medical subject headings
- Obesity, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical activityBehavioural
There is two sequences, one before and one after the physical activity program. Each sequence contains one "rest" session and one "exercise" session
| Study group | Role | What they receive |
|---|---|---|
| obesity | Experimental | Not described Receives: Behavioral: Physical activity |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: after 3 months of physical activity
Secondary outcomes (6)
Comparison, before and after the physical activity program, of Hunger sensation by Visual Analogic Scales
Measured: after 3 months of physical activity
Comparison, before and after the physical activity program of food intake
Measured: after 3 months of physical activity
Comparison, before and after the physical activity program of insulinosensibility
Measured: after 3 months of physical activity
Comparison, before and after the physical activity program of peripheral blood output
Measured: after 3 months of physical activity
Comparison, before and after the physical activity program of sleep quality
Measured: agter 3 months of physical activity
Comparison, before and after the physical activity program of physical condition
Measured: after 3 months of physical activity
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2013 (estimated)
- Study startOct 2012
- Primary completionMay 2014 (estimated)
- Study completionJul 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Etienne MERLIN, Principal investigator, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01824680
- Sponsor's protocol ID
- CHU-0149
- Acronym
- APHRO
- Status last verified
- Apr 2013
- First submitted
- 28 Feb 2013
- Last updated
- 5 Apr 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of a 3 Months Physical Activity Program on the Hormonal Regulation of Food Intake by Intense Physical Activity in Overweight Adolescents
- ClinicalTrials.gov ID
- NCT01824680
- Acronym / sponsor ID
- APHRO / CHU-0149
- Conditions
- Obesity
- Keywords
- Obesity, Appetite regulation, Hormones, Adolescents, Exercise
- Study type
- Interventional
- Recruitment status
- Suspended
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Study start
- Oct 2012
- Primary completion
- May 2014 (estimated)
- Study completion
- Jul 2014 (estimated)
- First posted
- 5 Apr 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
There is two sequences, one before and one after the physical activity program. Each sequence contains one "rest" session and one "exercise" session.
Each session contains : blood sample at regular interval (Leptin, Ghrélin, CCK, PYY, GLP-1), a sleeping assessment (Pittsburg scale), an assessment of hunger sensations at regular interval, an assessment of food intake in a "ad libitum" lunch and in the diner indirectly by the SU.VI.MAX. tool.
During the " rest " session :
Blood samples, assessment of hunger sensation, assessment of food intake are realized during the morning. Physical condition (VO2 max, DEXA, and muscular test), insulin-sensibility, lipid profile, are also assessed.
During the "exercise" session: it is identical to the first session but an intense exercise of 40 minutes is realized at 70% of the patient's VO2 max. The peripherical blood output is measured by a non-invasive method: the Near-Infra-Red-Spectroscopy, during the exercise.
The 3-months-physical activity program : there is 4 sessions of 30 minutes and 2 sessions of 1 hour per week. Most of exercises sessions are realized at home but one 1-hour session per week is controled with a sports educator.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| obesity | Experimental | Behavioral: Physical activity |
Who may qualify
- Ages
- 12 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Physical activityThere is two sequences, one before and one after the physical activity program. Each sequence contains one "rest" session and one "exercise" session | Behavioural | obesity |
Primary outcome
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
Time frame: after 3 months of physical activity
6 secondary outcomes
Comparison, before and after the physical activity program, of Hunger sensation by Visual Analogic Scales
Time frame: after 3 months of physical activity
Comparison, before and after the physical activity program of food intake
Time frame: after 3 months of physical activity
Comparison, before and after the physical activity program of insulinosensibility
Time frame: after 3 months of physical activity
Comparison, before and after the physical activity program of peripheral blood output
Time frame: after 3 months of physical activity
Comparison, before and after the physical activity program of sleep quality
Time frame: agter 3 months of physical activity
Comparison, before and after the physical activity program of physical condition
Time frame: after 3 months of physical activity
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Etienne MERLIN principal investigator
University Hospital, Clermont-Ferrand
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physical activity in people with Obesity, run by University Hospital, Clermont-Ferrand at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: paused, as of the sponsor's last update on 5 Apr 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: after 3 months of physical activity). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Apr 2013.