Type 2 DiabetesPhase 4NCT00264589
Exercise Training and Cardiovascular Function in Obesity and in Type 2 Diabetes
A Phase 4 study testing 8 weeks individualized training program in people with Type 2 Diabetes and Obesity, run by Centre Hospitalier Universitaire de Nīmes at 1 site in France.
Trial summary
Obesity and diabetes increase cardiovascular risk by complex and incompletely known mechanisms. The aims of this study are : 1. to compare cardiac and vascular functions at rest and during exercise in 4 groups of age-matched men, without cardiovascular diseases but exhibiting increasing cardiovascular risk: trained… Read more about this study
- Who is it for?
- Ages 18 to 65 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Type 2 Diabetes, Obesity
- What is being tested?
- 8 weeks individualized training program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 59 participants
- Where
- 1 siteFrance
- Study dates
- Dec 2005to 31 Dec 2010
- Phase
- Phase 4
- 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 18 to 65 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- non-diabetic obese subjects and type 2 diabetic subjects
Who cannot join
- smoking
- known peripheral artery insufficiency
- heart failure
- uncontrolled hypertension
- thyroid disease
- insulin dependent diabetes
- for diabetics subjects : HbA1c > 10 %
Trial locations and contacts
1 site in 1 country.
France1 site
Service d'Explorations et de Médecine Vasculaire University Hospital Center
Nîmes, Nimes, 30029
About this study
Official title: Effects of an Individualized Training Program on Cardiovascular Function at Rest and During Exercise in Obese and in Type 2 Diabetic Subjects
Obesity and diabetes increase cardiovascular risk by complex and incompletely known mechanisms. The aims of this study are :
- to compare cardiac and vascular functions at rest and during exercise in 4 groups of age-matched men, without cardiovascular diseases but exhibiting increasing cardiovascular risk: trained and untrained healthy volunteers, obese and type 2 diabetic subjects
- to test the effects of a 8-weeks long individualized training program on these functions in obese subjects and in diabetics patients.
Read the detailed description
Obesity, especially in its truncal distribution, and type 2 diabetes, increase cardiovascular risk. Mechanisms underlaying both early preclinical, and clinical cardiovascular complications are complex and still incompletely clarified.
However, relationship between central, i.e. cardiac, and peripheral, i.e. vascular dysfunctions remains unclear, as well as their respective role in reduced exercise tolerance in these populations.
Moreover, exercise training can improve both metabolic status and cardiovascular risk, and thus, has proven useful in management and prevention of chronic metabolic diseases. Nevertheless, respective effects of training on cardiac and vascular functions, and on their interaction at rest, but also during exercise, need to be clarified.
Therefore, the aims of this study are :
- to compare cardiac and vascular functions at rest and during a local maximal leg exercise in 4 groups of age-matched men, without cardiovascular diseases but exhibiting increasing cardiovascular risk: trained and untrained healthy volunteers, obese and type 2 diabetic subjects
- to test the effects of a 8-weeks long individualized training program on these functions in obese subjects and in diabetics patients.
- Conditions
- Type 2 Diabetes, Obesity
- Being tested
- 8 weeks individualized training program
- Keywords
- vascular function, cardiac function, individualized training, ultrasonography, body composition
- Medical subject headings
- Diabetes Mellitus, Type 2, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
8 weeks individualized training programBehavioural
no drugs added
| Study group | Role | What they receive |
|---|---|---|
| Study Population | Other | non-diabetic obese subjects and type 2 diabetic subjects
Intervention: 8 weeks individualized training program Receives: Behavioral: 8 weeks individualized training program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peripherical vascular function at rest and during exercise
Measured: before and after training
cardiac function at rest and during exercise
Measured: before and after training (8 weeks)
Secondary outcomes (4)
metabolic profile (biological data)
Measured: before and after training (8 weeks)
body composition and BMI
Measured: before and after training (8 weeks)
VO2
Measured: before and after training (8 weeks)
substrate utilization during exercise
Measured: before and after training (8 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2005 (estimated)
- Study startDec 2005
- Primary completion31 Dec 2010
- Study completion31 Dec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Type 2 DiabetesStudies 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 4
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nīmes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Antonia Pérez-Martin, MD, PhD, Principal investigator, University Hospital Center of Nimes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00264589
- Sponsor's protocol ID
- PHRC-I/2004/APM
- Other IDs
- DGS2005/0097
- Status last verified
- Mar 2015
- First submitted
- 12 Dec 2005
- Last updated
- 17 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
Publications
Vinet A, Karpoff L, Walther G, Startun A, Obert P, Goret L, Dauzat M, Perez-Martin A. Vascular reactivity at rest and during exercise in middle-aged obese men: effects of short-term, low-intensity, exercise training. Int J Obes (Lond). 2011 Jun;35(6):820-8. doi: 10.1038/ijo.2010.206. Epub 2010 Sep 28.
PubMed 20877288
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of an Individualized Training Program on Cardiovascular Function at Rest and During Exercise in Obese and in Type 2 Diabetic Subjects
- ClinicalTrials.gov ID
- NCT00264589
- Acronym / sponsor ID
- PHRC-I/2004/APM
- Conditions
- Type 2 Diabetes, Obesity
- Keywords
- vascular function, cardiac function, individualized training, ultrasonography, body composition
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NīmesUniversity, hospital or other
- Study start
- Dec 2005
- Primary completion
- 31 Dec 2010 (actual)
- Study completion
- 31 Dec 2010 (actual)
- First posted
- 13 Dec 2005 (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.
Obesity and diabetes increase cardiovascular risk by complex and incompletely known mechanisms. The aims of this study are :
- to compare cardiac and vascular functions at rest and during exercise in 4 groups of age-matched men, without cardiovascular diseases but exhibiting increasing cardiovascular risk: trained and untrained healthy volunteers, obese and type 2 diabetic subjects
- to test the effects of a 8-weeks long individualized training program on these functions in obese subjects and in diabetics patients.
Detailed description
Obesity, especially in its truncal distribution, and type 2 diabetes, increase cardiovascular risk. Mechanisms underlaying both early preclinical, and clinical cardiovascular complications are complex and still incompletely clarified.
However, relationship between central, i.e. cardiac, and peripheral, i.e. vascular dysfunctions remains unclear, as well as their respective role in reduced exercise tolerance in these populations.
Moreover, exercise training can improve both metabolic status and cardiovascular risk, and thus, has proven useful in management and prevention of chronic metabolic diseases. Nevertheless, respective effects of training on cardiac and vascular functions, and on their interaction at rest, but also during exercise, need to be clarified.
Therefore, the aims of this study are :
- to compare cardiac and vascular functions at rest and during a local maximal leg exercise in 4 groups of age-matched men, without cardiovascular diseases but exhibiting increasing cardiovascular risk: trained and untrained healthy volunteers, obese and type 2 diabetic subjects
- to test the effects of a 8-weeks long individualized training program on these functions in obese subjects and in diabetics patients.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study Population | Other | Behavioral: 8 weeks individualized training programnon-diabetic obese subjects and type 2 diabetic subjects Intervention: 8 weeks individualized training program |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- non-diabetic obese subjects and type 2 diabetic subjects
Key exclusion criteria (7 listed)
- smoking
- known peripheral artery insufficiency
- heart failure
- uncontrolled hypertension
- thyroid disease
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 |
|---|---|---|
| 8 weeks individualized training programno drugs added | Behavioural | Study Population |
Primary outcome
Peripherical vascular function at rest and during exercise
Time frame: before and after training
cardiac function at rest and during exercise
Time frame: before and after training (8 weeks)
4 secondary outcomes
metabolic profile (biological data)
Time frame: before and after training (8 weeks)
body composition and BMI
Time frame: before and after training (8 weeks)
VO2
Time frame: before and after training (8 weeks)
substrate utilization during exercise
Time frame: before and after training (8 weeks)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2025.
- Results publication: PubMed 20877288Vinet A, Karpoff L, Walther G, Startun A, Obert P, Goret L, Dauzat M, Perez-Martin A. Vascular reactivity at rest and during exercise in middle-aged obese men: effects of short-term, low-intensity, exercise training. Int J Obes (Lond). 2011 Jun;35(6):820-8. doi: 10.1038/ijo.2010.206. Epub 2010 Sep 28.
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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.
Antonia Pérez-Martin, MD, PhD principal investigator
University Hospital Center of Nimes
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing 8 weeks individualized training program in people with Type 2 Diabetes and Obesity, run by Centre Hospitalier Universitaire de Nīmes 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 1 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: finished, as of the sponsor's last update on 17 Nov 2025. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Peripherical vascular function at rest and during exercise (time frame: before and after training). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00264589, which also lists 1 linked publication.
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 17 Nov 2025.