Diabetes Mellitus, Type 2PAPA-NAQUINCT06493955
Evaluation of the Effectiveness of Extending the "Passerelle" System for Prescribing Adapted Physical Activity to Patients With Type 2 Diabetes in Nouvelle-AQUItaine (France)
A study testing Adapted physical activity for 12 months and Adapted physical activity for 6 months in people with Diabetes Mellitus, Type 2, run by University Hospital, Bordeaux at 1 site in France.
Trial summary
Type 2 diabetes is on the increase worldwide. Two major risk factors have been identified: overweight and physical inactivity. National and international recommendations encourage general practitioner to guide patients in changing their lifestyle. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- Adapted physical activity for 12 months and Adapted physical activity for 6 months
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 308 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2026to Sep 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with type 2 diabetes with initial diagnosis of fasting blood glucose > 1.26 g/l on 2 occasions
- Patient aged 18 or over
- Patient with a Marshall score ≤ 3
- Patient residing in the Nouvelle-Aquitaine region
- Patient eligible for the "Passerelle" program
- Patient willing to participate
- Patient agreeing to take part in the study and having signed an informed consent form
- Person affiliated or benefiting from a social security scheme.
Who cannot join
- Patient with any other unstabilized pathology:
- Cardiovascular: unstable angina, stress angina, malignant hypertension, recent myocardial infarction, unstabilized heart disease
- Pulmonary: uncontrolled asthma, COPD exacerbation
- Endocrine: diabetes with HbA1c > 9%, plantar perforator disease
- Pregnant patient
- Diabetic patient with contraindication to APA prescription
- Patient under court protection
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
CUGERONE Arnaud, Dr contact
France1 site
Cabinet Médical Bergerac
Bergerac
Arnaud CUGERONE, Dr, arnaud.cugerone@u-bordeaux.fr
About this study
Type 2 diabetes is on the increase worldwide. Two major risk factors have been identified: overweight and physical inactivity. National and international recommendations encourage general practitioner to guide patients in changing their lifestyle. As regards physical activity in France, general practitioner have been able to prescribe adapted physical activity (APA) for their patients since 2016. In type 2 diabetes, it is known that physical activity interventions are cost-effective. However, these interventions are often too expensive and far removed from real life. It is also known that the benefits of intervention increase up to 18 months, then diminish to zero at 36 months. In Nouvelle-Aquitaine, France, the "PEPS Sport-santé network", offers physical activity coaching for patients who are not sufficiently active: the "Passerelle" program. Patients can benefit from a weekly physical activity session for 6 months.
The investigators would therefore like to assess whether extending the existing "Passerelle program" by 6 months, with one session every 15 days, is effective in maintaining the volume of physical activity 12 months after the end of the intervention.
Read the detailed description
Over the last few decades, we have witnessed an increasing rise in the prevalence of chronic diseases, including type 2 diabetes (T2DM). Internationally, diabetes affected 108 million people in the 1980s, compared with 451 million in 2017, reaching epidemic proportions according to the World Health Organization (WHO). France has not been spared by T2DM, with an estimated prevalence of 11.8% in 2017 and an incidence of 10.7 cases per 1,000 person-years. The chronic hyperglycemia of type 2 diabetes is associated with altered macronutrient metabolism, with a lack of insulin secretion or reduced insulin sensitivity. Insulin resistance impairs the ability of muscle cells to absorb and store glucose. Two major modifiable risk factors have been identified: overweight and physical inactivity. T2DM increases the risk of myocardial infarction and stroke by a factor of 2 to 3. The ENTRED 3 study carried out in 2019 among diabetic patients in mainland France showed that 18.6% of type 2 diabetic patients had had a coronary complication and 7.8% a stroke. In addition to these two macro-vascular complications, diabetes is responsible for micro-vascular complications such as retinopathy and diabetic nephropathy. The cost to society of physical inactivity is considerable. Worldwide, healthcare expenditure linked to T2DM and physical inactivity has been estimated at 37.6 billion dollars.
The management of type 2 diabetic patients aims to reduce morbidity and mortality through glycemic control. The latest French recommendations for the management of diabetic patients date from 2014, and encourage doctors to monitor their patients every three months to ensure compliance, look for risk factors and comorbidities (hypertension, smoking and alcohol consumption), measure blood pressure, weight and calculate BMI. HbA1c tests should be carried out between two and four times a year. The first recommended hypoglycemic treatment is based on physical activity and diet.
More recent recommendations from the American Diabetes Association (ADA) in 2022 encourage physicians to manage patients using a multifactorial approach. First-line management involves lifestyle changes, promoting healthier behaviors around diet, physical activity promotion, substance use such as smoking, weight loss and sleep quality.
Sport-health networks such as the PEPS network in the Nouvelle-Aquitaine region (Prescription d'Exercice Physique pour la Santé - Prescription of Physical Exercise for Health) make it easier for patients to be referred to a suitable structure for supervised exercise.
Investigators would like to know whether extending this program with spaced sessions can encourage patients to change their behavior over the long term. Spacing out the sessions should enable a smoother transition to independent or associative practice.
The research question is as follows: What is the effectiveness of a one-year Passerelle program in maintaining the volume of physical activity in T2DM patients in the Nouvelle-Aquitaine region?
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- Adapted physical activity for 12 months, Adapted physical activity for 6 months
- Keywords
- Diabetes Mellitus, Type 2, Adapted Physical Activity, general practice
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adapted physical activity for 12 monthsOther
6 additional months of adapted physical activity after the 6 first months
Adapted physical activity for 6 monthsOther
standard 6-month prescription for adapted physical activity
| Study group | Role | What they receive |
|---|---|---|
| experimental arm | Experimental | Patients with type 2 diabetes included in the adapted physical activity arm for 12 months Receives: Other: Adapted physical activity for 12 months |
| control arm | Active comparator | Type 2 diabetes patients with standard prescription for adapted physical activity (6 months) Receives: Other: Adapted physical activity for 6 months |
What is being measured
The primary outcome is the main question the study is designed to answer.
ONAPS-PAQ questionnaire,
Measurement of weekly physical activity volume using the " national observatory on physical activity and sedentariness - physical activity questionnaire" (ONAPS-PAQ), score given in minutes per week : under 150 min/week : Higher early mortality risk, associated with a sharp increase in the risk of chronic diseases above 150min/week : reduced risk of early mortality risk of developing chronic diseases
Measured: 12 months after the end of the intervention
Secondary outcomes (7)
Physical activity
changes in physical activity volume at baseline and then every 6 months until the end of the study
Measured: Month 0 (inclusion) and Month 6, Month 12, Month 18, Month 24 after inclusion
Sedentariness
ONAPS PAQ sedentariness score :
score in minutes of activity : under 150 min/week : Higher early mortality risk, associated with a sharp increase in the risk of chronic diseases above 150min/week : reduced risk of early mortality risk of developing chronic diseases
Measured: At inclusion and 6 months after inclusion and 12 months after the end of the intervention.
Weight change
Difference in weight change between the two groups
Measured: At inclusion and 6 months after inclusion and 12 months after the end of the intervention.
Walk test
6-minute walk test
Measured: At inclusion and 6 months after inclusion and 12 months after the end of the intervention.
Therapeutic escalation
Difference in therapeutic escalation level between the two groups
Measured: 12 months after the end of the intervention.
HbA1c
Difference in HbA1c between the two groups
Measured: At inclusion and 6 months after inclusion and 12 months after the end of the intervention.
Quality of life (SF-36)
Difference in quality of life score between the two groups, measured by the SF-36 quality of life scale.
The SF-36 scale ranges from 0 to 100. A low score reflects a perception of poor health, loss of function and the presence of pain. A high score reflects a perception of good health, absence of functional deficit and pain.
Measured: At inclusion and 6 months after inclusion and 12 months after the end of the intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2024
- Study startSep 2026 (estimated)
- Primary completionSep 2029 (estimated)
- Study completionSep 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- More trials run by University Hospital, BordeauxThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- comparative, multicenter, interventional, superiority study, randomized in two unblinded parallel groups. Randomization will be 1:1.
- Masking
- None (open label)
- Enrolment
- 308 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06493955
- Sponsor's protocol ID
- CHUBX 2023/47
- Acronym
- PAPA-NAQUI
- Status last verified
- Aug 2026
- First submitted
- 2 Jul 2024
- Last updated
- 7 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effectiveness of Extending the "Passerelle" System for Prescribing Adapted Physical Activity to Patients With Type 2 Diabetes in Nouvelle-AQUItaine (France)
- ClinicalTrials.gov ID
- NCT06493955
- Acronym / sponsor ID
- PAPA-NAQUI / CHUBX 2023/47
- Conditions
- Diabetes Mellitus, Type 2
- Keywords
- Diabetes Mellitus, Type 2, Adapted Physical Activity, general practice
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 308 participants (estimated)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Study start
- Sep 2026 (estimated)
- Primary completion
- Sep 2029 (estimated)
- Study completion
- Sep 2029 (estimated)
- First posted
- 10 Jul 2024 (actual)
- 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.
Type 2 diabetes is on the increase worldwide. Two major risk factors have been identified: overweight and physical inactivity. National and international recommendations encourage general practitioner to guide patients in changing their lifestyle. As regards physical activity in France, general practitioner have been able to prescribe adapted physical activity (APA) for their patients since 2016. In type 2 diabetes, it is known that physical activity interventions are cost-effective. However, these interventions are often too expensive and far removed from real life. It is also known that the benefits of intervention increase up to 18 months, then diminish to zero at 36 months. In Nouvelle-Aquitaine, France, the "PEPS Sport-santé network", offers physical activity coaching for patients who are not sufficiently active: the "Passerelle" program. Patients can benefit from a weekly physical activity session for 6 months.
The investigators would therefore like to assess whether extending the existing "Passerelle program" by 6 months, with one session every 15 days, is effective in maintaining the volume of physical activity 12 months after the end of the intervention.
Detailed description
Over the last few decades, we have witnessed an increasing rise in the prevalence of chronic diseases, including type 2 diabetes (T2DM). Internationally, diabetes affected 108 million people in the 1980s, compared with 451 million in 2017, reaching epidemic proportions according to the World Health Organization (WHO). France has not been spared by T2DM, with an estimated prevalence of 11.8% in 2017 and an incidence of 10.7 cases per 1,000 person-years. The chronic hyperglycemia of type 2 diabetes is associated with altered macronutrient metabolism, with a lack of insulin secretion or reduced insulin sensitivity. Insulin resistance impairs the ability of muscle cells to absorb and store glucose. Two major modifiable risk factors have been identified: overweight and physical inactivity. T2DM increases the risk of myocardial infarction and stroke by a factor of 2 to 3. The ENTRED 3 study carried out in 2019 among diabetic patients in mainland France showed that 18.6% of type 2 diabetic patients had had a coronary complication and 7.8% a stroke. In addition to these two macro-vascular complications, diabetes is responsible for micro-vascular complications such as retinopathy and diabetic nephropathy. The cost to society of physical inactivity is considerable. Worldwide, healthcare expenditure linked to T2DM and physical inactivity has been estimated at 37.6 billion dollars.
The management of type 2 diabetic patients aims to reduce morbidity and mortality through glycemic control. The latest French recommendations for the management of diabetic patients date from 2014, and encourage doctors to monitor their patients every three months to ensure compliance, look for risk factors and comorbidities (hypertension, smoking and alcohol consumption), measure blood pressure, weight and calculate BMI. HbA1c tests should be carried out between two and four times a year. The first recommended hypoglycemic treatment is based on physical activity and diet.
More recent recommendations from the American Diabetes Association (ADA) in 2022 encourage physicians to manage patients using a multifactorial approach. First-line management involves lifestyle changes, promoting healthier behaviors around diet, physical activity promotion, substance use such as smoking, weight loss and sleep quality.
Sport-health networks such as the PEPS network in the Nouvelle-Aquitaine region (Prescription d'Exercice Physique pour la Santé - Prescription of Physical Exercise for Health) make it easier for patients to be referred to a suitable structure for supervised exercise.
Investigators would like to know whether extending this program with spaced sessions can encourage patients to change their behavior over the long term. Spacing out the sessions should enable a smoother transition to independent or associative practice.
The research question is as follows: What is the effectiveness of a one-year Passerelle program in maintaining the volume of physical activity in T2DM patients in the Nouvelle-Aquitaine region?
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- comparative, multicenter, interventional, superiority study, randomized in two unblinded parallel groups. Randomization will be 1:1.
| Arm | Type | Receives |
|---|---|---|
| experimental arm | Experimental | Other: Adapted physical activity for 12 monthsPatients with type 2 diabetes included in the adapted physical activity arm for 12 months |
| control arm | Active comparator | Other: Adapted physical activity for 6 monthsType 2 diabetes patients with standard prescription for adapted physical activity (6 months) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Patients with type 2 diabetes with initial diagnosis of fasting blood glucose > 1.26 g/l on 2 occasions
- Patient aged 18 or over
- Patient with a Marshall score ≤ 3
- Patient residing in the Nouvelle-Aquitaine region
- Patient eligible for the "Passerelle" program
Key exclusion criteria (7 listed)
- Patient with any other unstabilized pathology:
- Cardiovascular: unstable angina, stress angina, malignant hypertension, recent myocardial infarction, unstabilized heart disease
- Pulmonary: uncontrolled asthma, COPD exacerbation
- Endocrine: diabetes with HbA1c > 9%, plantar perforator disease
- Pregnant patient
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 |
|---|---|---|
| Adapted physical activity for 12 months6 additional months of adapted physical activity after the 6 first months | Other | experimental arm |
| Adapted physical activity for 6 monthsstandard 6-month prescription for adapted physical activity | Other | control arm |
Primary outcome
ONAPS-PAQ questionnaire,
Time frame: 12 months after the end of the intervention
Measurement of weekly physical activity volume using the " national observatory on physical activity and sedentariness - physical activity questionnaire" (ONAPS-PAQ), score given in minutes per week : under 150 min/week : Higher early mortality risk, associated with a sharp increase in the risk of chronic diseases above 150min/week : reduced risk of early mortality risk of developing chronic diseases
7 secondary outcomes
Physical activity
Time frame: Month 0 (inclusion) and Month 6, Month 12, Month 18, Month 24 after inclusion
Sedentariness
Time frame: At inclusion and 6 months after inclusion and 12 months after the end of the intervention.
Weight change
Time frame: At inclusion and 6 months after inclusion and 12 months after the end of the intervention.
Walk test
Time frame: At inclusion and 6 months after inclusion and 12 months after the end of the intervention.
Therapeutic escalation
Time frame: 12 months after the end of the intervention.
HbA1c
Time frame: At inclusion and 6 months after inclusion and 12 months after the end of the intervention.
Quality of life (SF-36)
Time frame: At inclusion and 6 months after inclusion and 12 months after the end of the intervention.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2026.
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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.
CUGERONE Arnaud, Dr contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Adapted physical activity for 12 months and Adapted physical activity for 6 months in people with Diabetes Mellitus, Type 2, run by University Hospital, Bordeaux 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 8 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: opening soon, as of the sponsor's last update on 7 Aug 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact CUGERONE Arnaud, Dr (arnaud.cugerone@u-bordeaux.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ONAPS-PAQ questionnaire, (time frame: 12 months after the end of the intervention). 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 7 Aug 2026.