Overweight/ObesityNCT01349166
Effects of 3 Months of Supervised Exercise Training
A study testing Behavior: Supervised physical training in people with Overweight/Obesity and Glucose Intolerance, run by University Hospital, Clermont-Ferrand.
Trial summary
The incidence of type 2 diabetes is increasing worldwide. Because of cardiovascular morbidity and mortality associated with type 2 diabetes, it is imperative to propose methods of prevention and this in early stage of abnormal glucose metabolism. Read more about this study
- Who is it for?
- Ages 30 to 65 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Overweight/Obesity, Glucose Intolerance, Type 2 Diabetes
- What is being tested?
- Behavior: Supervised physical training
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 45 participants
- Where
- No sites listed yet
- Study dates
- Feb 2008to Feb 2012
- 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 30 to 65 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male Caucasian Adults between 30 and 65 years old Sedentary criteria based on the determination of fasting glucose (WHO 1999):
- normal if fasting plasma glucose (FPG) <1.10 g / l
- diabetes if fasting glucose> 1.26 g / l (7 mmol / l) twice
- nondiabetic fasting hyperglycemia: 1.10 g / l ≤ FPG ≤ 1.26 g / l
- glucose intolerance : if plasma glucose at 120 minutes during the OGTT (75g) is between 1.40 g / l and 2 g/ l.
- Body mass index 25 BMI 35kg/m2 Affiliated to National Health Insurance Subject giving his written informed consent Subject considered as normal after clinical examination and medical questionnaire
Who cannot join
- - drugs that interfere with the parameters determined
- diabetic treated with insulin, glitazones or glinides
- eating disorders like bulimia and vomiting
- special diet, vegan or vegetarian
- autoimmune disease or inflammatory progressive desease requiring prolonged treatment
- regular physical activity (> 1 hour of physical activity per week for at least 6 months)
Show all 15Show fewer
- smoking (> 5 cigarettes / day)
- weight change greater than 5% of the total weight in the 3 months preceding the study
- contra-indication to physical activity
- chronic pathologies: cancer, inflammatory, cardiac, pulmonary, renal, gastrointestinal or liver diseases
- Being in exclusion on the National Volunteers Data file
- No one under guardianship or not subject to social security.
- Being under someone's supervision
- Subjects deprived of their liberty by judicial or administrative.
- Refusal to sign the information sheet and written consent for particip
About this study
Official title: Effects of 3 Months of Supervised Exercise Training on Cardiometabolic and Inflammatory Biomarkers According to Glucose Tolerance (Normal, Intolerance and Type 2 Diabetes): Measures in Unstimulated and Stimulated Conditions
The incidence of type 2 diabetes is increasing worldwide. Because of cardiovascular morbidity and mortality associated with type 2 diabetes, it is imperative to propose methods of prevention and this in early stage of abnormal glucose metabolism.
This study will assess the beneficial effects of physical activity (acute and chronic effects) (the subjects being their own controls) on cardiometabolic and inflammatory biomarkers in 3 conditions : unstimulated (fasting and resting conditions) and stimulated conditions: postprandial response to a standardized meal preceded or not by an exercise bout.
The investigators hypothesized that an acute bout of exercise will decrease the postprandial inflammatory response to a standardized meal and that this effect of exercise will be increased after 3 months of exercise training.
Read the detailed description
This is a prospective study over 4 months, open, nonrandomized. 45 overweight or obese male subjects will complete 3 experimental sessions (0700-1400h) before and after 3 months of supervised physical training. During a first session, subjects will remain inactive and fasted (basal conditions). During the second session a standardized meal will be offered (postprandial response to a standardized meal). The third session will consist in the realization of an exercise bout (60min at 60%VO2 max) followed by a standardized meal (same meal that the previous day).
Several blood (catheter), salivary and urinary samples will be collected during the 3 sessions, throughout the experimental day.
- Conditions
- Overweight/Obesity, Glucose Intolerance, Type 2 Diabetes, Sedentarity
- Being tested
- Behavior: Supervised physical training
- Keywords
- Obesity, Type 2 diabetes, glucose intolerance, Physical Activity, Inflammation, HPA axis, Cytokines
- Medical subject headings
- Overweight, Obesity, Glucose Intolerance, Diabetes Mellitus, Type 2, Motor Activity, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Behavior: Supervised physical trainingBehavioural
protocol designed to evaluate effects of physical activity on cardiometabolic and inflammatory biomarkers according to glucose tolerance
What is being measured
The primary outcome is the main question the study is designed to answer.
supervised physical training on cardiometabolic and inflammatory biomarkers
Measured: after 3 months
Secondary outcomes (1)
relationships between cortisol secretion and the postprandial inflammatory responses depending on the level of glucose tolerance
Measured: after 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2011 (estimated)
- Study startFeb 2008
- Primary completionAug 2011 (estimated)
- Study completionFeb 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Overweight/ObesityStudies of the same condition, open and under way.
- More trials run by University Hospital, Clermont-FerrandThe sponsor's other registered studies.
- 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
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Collaborators
- Centre de Recherche en Nutrition Humaine d'Auvergne
- Investigators
- Martine DUCLOS, Principal investigator, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01349166
- Sponsor's protocol ID
- CHU-0088
- Status last verified
- May 2011
- First submitted
- 3 Feb 2011
- Last updated
- 6 May 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of 3 Months of Supervised Exercise Training on Cardiometabolic and Inflammatory Biomarkers According to Glucose Tolerance (Normal, Intolerance and Type 2 Diabetes): Measures in Unstimulated and Stimulated Conditions
- ClinicalTrials.gov ID
- NCT01349166
- Acronym / sponsor ID
- CHU-0088
- Conditions
- Overweight/Obesity, Glucose Intolerance, Type 2 Diabetes, Sedentarity
- Keywords
- Obesity, Type 2 diabetes, glucose intolerance, Physical Activity, Inflammation, HPA axis, Cytokines
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Collaborators
- Centre de Recherche en Nutrition Humaine d'Auvergne
- Study start
- Feb 2008
- Primary completion
- Aug 2011 (estimated)
- Study completion
- Feb 2012 (estimated)
- First posted
- 6 May 2011 (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 incidence of type 2 diabetes is increasing worldwide. Because of cardiovascular morbidity and mortality associated with type 2 diabetes, it is imperative to propose methods of prevention and this in early stage of abnormal glucose metabolism.
This study will assess the beneficial effects of physical activity (acute and chronic effects) (the subjects being their own controls) on cardiometabolic and inflammatory biomarkers in 3 conditions : unstimulated (fasting and resting conditions) and stimulated conditions: postprandial response to a standardized meal preceded or not by an exercise bout.
The investigators hypothesized that an acute bout of exercise will decrease the postprandial inflammatory response to a standardized meal and that this effect of exercise will be increased after 3 months of exercise training.
Detailed description
This is a prospective study over 4 months, open, nonrandomized. 45 overweight or obese male subjects will complete 3 experimental sessions (0700-1400h) before and after 3 months of supervised physical training. During a first session, subjects will remain inactive and fasted (basal conditions). During the second session a standardized meal will be offered (postprandial response to a standardized meal). The third session will consist in the realization of an exercise bout (60min at 60%VO2 max) followed by a standardized meal (same meal that the previous day).
Several blood (catheter), salivary and urinary samples will be collected during the 3 sessions, throughout the experimental day.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 30 to 65 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male Caucasian Adults between 30 and 65 years old Sedentary criteria based on the determination of fasting glucose (WHO 1999):
- normal if fasting plasma glucose (FPG) <1.10 g / l
- diabetes if fasting glucose> 1.26 g / l (7 mmol / l) twice
- nondiabetic fasting hyperglycemia: 1.10 g / l ≤ FPG ≤ 1.26 g / l
- glucose intolerance : if plasma glucose at 120 minutes during the OGTT (75g) is between 1.40 g / l and 2 g/ l.
Key exclusion criteria (15 listed)
- - drugs that interfere with the parameters determined
- diabetic treated with insulin, glitazones or glinides
- eating disorders like bulimia and vomiting
- special diet, vegan or vegetarian
- autoimmune disease or inflammatory progressive desease requiring prolonged treatment
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 |
|---|---|---|
| Behavior: Supervised physical trainingprotocol designed to evaluate effects of physical activity on cardiometabolic and inflammatory biomarkers according to glucose tolerance | Behavioural | – |
Primary outcome
supervised physical training on cardiometabolic and inflammatory biomarkers
Time frame: after 3 months
1 secondary outcome
relationships between cortisol secretion and the postprandial inflammatory responses depending on the level of glucose tolerance
Time frame: after 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2011.
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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.
Martine DUCLOS principal investigator
University Hospital, Clermont-Ferrand
Questions about this trial
What is this clinical trial studying?
A study testing Behavior: Supervised physical training in people with Overweight/Obesity and Glucose Intolerance, run by University Hospital, Clermont-Ferrand.
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 6 inclusion and 15 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: status not confirmed, as of the sponsor's last update on 6 May 2011. Status can change between updates, so confirm with the study contact before making plans.
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?
supervised physical training on cardiometabolic and inflammatory biomarkers (time frame: after 3 months). 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 6 May 2011.