Type2 DiabetesACTIDIANENCT03184662
Efficacy of a High-intensity Physical Activity Program on Renal Function in High Risk Patients With Type 2 Diabetes
A study testing HIPA and Counseling PA in people with Type2 Diabetes and Diabetic Kidney Disease, run by Poitiers University Hospital at 20 sites in 2 countries.
Trial summary
Type 2 diabetes is a chronic condition whose prevalence is increasing globally. Kidney disease is a key complication of diabetes and is among the most common cause of end-stage renal disease, requiring renal replacement therapy. Read more about this study
- Who is it for?
- Ages 45 years and older
- Conditions the study is for
- Type2 Diabetes, Diabetic Kidney Disease
- What is being tested?
- HIPA and Counseling PA
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 178 participants
- Where
- 20 sitesin 2 countries
- Study dates
- 12 Feb 2018to 28 Jul 2023
- 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 45 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Type 2 diabetes
- Rapid renal decline function (yearly loss of eGFR over -5ml/min/1.73 m2) in the 6 to 24 preceding months
Who cannot join
- Lower limb amputation
- Indication for rehabilitation program
- Contra-indication for physical activity
- Unstable angina, left atrial thrombus,
- Unstable thyroid function
- Corticosteroids treatment
- Long-term NSAIDs
- Simultaneous participation to any interventional study able to interfere with the current study endpoints
Trial locations and contacts
20 sites in 2 countries.
20 sites in 2 countries
France19 sites
Besançon Hospital
Besançon
Bordeaux University Hospital
Bordeaux, 33000
Caen University Hospital
Caen, 14033
CH Chartres
Chartres
Clermont Ferrand University Hospital
Clermont-Ferrand, 63000
CHG Sud Francilien
Corbeil-Essonnes, 91100
CHU Dijon
Dijon, 21000
CHU Lille
Lille, 59000
Chu de Lyon
Lyon, 69229
CHRU
Montpellier
CHU Nancy
Nancy, 54000
Chu de Nice
Nice, 06003
Bichat University Hospital
Paris, 75000
La Riboisière Hospital
Paris, 75000
Hôpital Pitié Salpétrière
Paris, 75651
Poitiers University Hospital
Poitiers, 86000
CHU Strasbourg
Strasbourg, 67000
CHU Toulouse
Toulouse, 31000
CHU de TOURS
Tours, 37044
About this study
Official title: Randomized Trial to Assess the Efficacy of a High-intensity Physical Activity Program on Renal Function Decline in High Risk Patients With Type 2 Diabetes
Type 2 diabetes is a chronic condition whose prevalence is increasing globally. Kidney disease is a key complication of diabetes and is among the most common cause of end-stage renal disease, requiring renal replacement therapy.
It has been shown that the trajectory of renal function (estimated glomerular filtration rate - eGFR) is of great prognostic value for renal and cardiovascular endpoints in diabetic patients. However the clinical use of this prognostic marker is not associated to date with a clear therapeutic intervention, effective in patients with type 2 diabetes identified with this biomarker.
Read more
In France, type 2 diabetes patients have twice less physical activity than non-diabetic persons. Recently, it has been published that physical activity was associated with an improvement of renal risk in patients with type 2 diabetes, recruited from the LOOK-AHEAD study. It was demonstrated that high-intensity physical activity (HIPA) can have several additional advantages over moderate-intensity, on blood pressure improvement, and cardiovascular risk profile modification. In addition, this procedure was shown to be safe in patients with high cardiovascular risk.
We plan to perform a randomized intervention comparing a structured program of high-intensity physical activity (HIPA) vs standard recommendations for physical activity on renal function decline (primary outcome) and mortality, renal and cardiovascular endpoints, patients' safety and quality of life (secondary outcomes). Study participants will be patients with established type 2 diabetes and a high renal risk, identified by rapid renal function decline, defined as a eGFR slope below -5ml/min per 1.73 m2/yr. The intervention is planned to last for 2 years.
Read the detailed description
I- Visit organisation
V1 (screening) informed consent / examination / inclusion and non-inclusion criteria / medical history M/F LUTS / EPICES score / ECG Serum creatinine determination
V2 (Randomization) examination / verification of participation criteria / randomization Cystatin C collection / Biology Hypoglycemia notification / QAPPA / RPAQ / NAQA / Questionnaires (EQ-5D3L, SF12, Rosenberg Self esteem) / Accelerometer (ancillary) / Impedance-meter (ancillary) 6-minute step test / 10-meter walk test
V3 (1 month) examination / Hypoglycemia notification / QAPPA / RPAQ / Accelerometer (ancillary)
V4 (3 months) examination / Hypoglycemia notification / QAPPA / RPAQ / Questionnaires (EQ-5D3L, SF12, Rosenberg Self esteem) / Accelerometer (ancillary) 6-minute step test Biology
V5 (6 months) examination / Hypoglycemia notification / QAPPA / RPAQ / Questionnaires(EQ-5D3L, SF12, Rosenberg Self esteem) / Accelerometer (ancillary) 6-minute step test Cystatin C collection / Biology
V6 (12 months) examination / Hypoglycemia notification / QAPPA / RPAQ / NAQA / M/F LUTS / Questionnaires(EQ-5D3L, SF12, Rosenberg Self esteem) / ECG /Accelerometer (ancillary) / Impedance-meter (ancillary) Cystatin C collection / Biology 6-minute step test / 10-meter walk test
V7 (18 months) examination / Hypoglycemia notification / QAPPA / RPAQ / Questionnaires(EQ-5D3L, SF12, Rosenberg Self esteem) / Accelerometer (ancillary) Cystatin C collection / Biology 6-minute step test
V8 (24 months) / premature discontinuation examination / Hypoglycemia notification / QAPPA / RPAQ / NAQA / M/F LUTS / Questionnaires (EQ-5D3L, SF12, Rosenberg Self esteem) / ECG / Accelerometer (ancillary) / Impedance-meter (ancillary) 6-minute step test / 10-meter walk test Cystatin C collection / Biology
II- Recruitment criteria Inclusion
- Age : 45 and higher
- Female or male
- Type 2 diabetes with diabetes typing according to widely-accepted clinical and biological criteria [3].
- Subject able to practice physical activity. This includes a normal exercise test with or without anti-ischemic drugs, performed in the preceding 6 months or short before randomization. A certificate of no contre-indication for PA is to be delivered prior to randomization.
- With at least 3 available creatinine measurements in the 6 to 24 preceding months showing a rapid renal function decline defined as an eGFR slope below -5 ml/min/yr
- Estimated GFR equal to or higher than 30 ml/min/1.73m², defined by the CKD-EPI formula, at inclusion visit
Non inclusion
- Age strictly lower than 45 years
- Indication for cardiovascular rehabilitation (notably patient with ischemic heart disease or coronary revascularisation)
- Treatment with systemic NSAIDs or corticosteroids
- Lower limb amputation (above trans-metacarpal)
- Active proliferative retinopathy (risk of bleeding in case of effort)
- Contra-indication for the participation to PA:
- Severe non-operated valvulopathy
- Uncontrolled hypertension > 180/110 mmHg
- Thrombus in the left ventricular cavity
- Unstable coronaropathy, according to physician
- NYHA stage IV heart failure
- Any condition that would jeopardize patient's safety or would affect the conduct of the study
- Pregnant or breast-feeding women or women of child-bearing potential without effective contraception during the study
- Any situation associated with unreliable cystatin-C determinations, according to patient medical history: HIV positivity, melanoma and thyroid dysfunction
- Simultaneous participation to any interventional study able to interfere with the current study endpoints
- Patients not registered to the social security
- Protected adults (under guardianship and trusteeship)
- Subject unable to express their consent (due to intellectual/mental incapacity)
III- Intervention HIPA group Twice weekly physical activity session in a dedicated structure, supervised by a graduated coach, alternating sessions of strengthening and intermittent HIPA, allowing a mixed stimulation of neuro-muscular and cardiovascular systems, and regular (every 3 months) adjustment of the intensity of the program.
Control group Counseling of physical activity according to recommendations from the working group on Physical Activity of the SFD (French Language Diabetes Society) supported by patient's oriented leaflet.
IV- Handling with the COVID-19 pandemics
The COVID-19 pandemics has modified the shape of the study with
- difficulties to comply with the study plan, including recruitment pace. Visits can be postponed if required but investigators are encouraged to follow the initial plan. The time between randomization and V3 (1 month) and V4 (3 months) can sometimes be too short and it is acceptable to perform this visit by phone or even to cancel it.
- difficulties to comply with physical activity (PA) plan. As PA facilities have been locked down in the pandemics context, the sports committee of the ACTIDIANE study has agreed to move attendances to the gym to some remote PA sessions, via websession or if not possible, via telephone coaching sessions.
- Conditions
- Type2 Diabetes, Diabetic Kidney Disease
- Being tested
- HIPA, Counseling PA
- Keywords
- High-intensity physical activity, Diabetes, Renal function decline
- Medical subject headings
- Diabetic Nephropathies, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HIPAOther
inclusion in a program with 2 weekly sessions of structured physical activity of 1 hour in a dedicated structure, under the supervision of a graduated coach.
First 3 months : physical reconditioning 3 months and after: alternating sessions of physical strengthening and intermittent high-intensity physical activity Adaptation of the intensity of the program according to evaluation tests every 3 months
Counseling PAOther
Counseling of physical activity according to recommendations from the working group on Physical Activity of the SFD
| Study group | Role | What they receive |
|---|---|---|
| HIPA group | Experimental | Twice weekly physical activity session in a dedicated structure, supervised by a graduated coach, alternating sessions of strengthening and intermittent HIPA, allowing a mixed stimulation of neuro-muscular and cardiovascular systems, and regular (every 3 months) adjustment of the intensity of the program.
The sessions will be preferably performed in sports gyms but if required can also be performed online with supervised coaches, trained for the study. Receives: Other: HIPA |
| Control group | Active comparator | Counseling of physical activity according to recommendations from the working group on Physical Activity of the SFD (French Language Diabetes Society). Receives: Other: Counseling PA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Renal Function Decline
Estimated glomerular filtration rate slope computed within 2 years, evaluated with the cystatin-derived CKD-EPI formula At least 3 available determinations of estimated glomerular filtration rate will be required to perform the calculation of the slope
Measured: 2 years
Secondary outcomes (13)
Incidence of ESRF
Incidence of end-stage renal failure requiring renal replacement therapy
Measured: 2 years
Number of patients with a decrease in eGRF
Number of patients with a decrease in eGRF greater than 40% of baseline value
Measured: 2 years
All cause death
Number of patients who died during the study (all cause)
Measured: 2 years
Cardiovascular death
Cardiovascular death as proposed by the ICD-10 classification
Measured: 2 years
Renal death
Renal death as defined as a situation where renal replacement therapy could be used but was not applied
Measured: 2 years
MACE
MACE : major adverse cardiovascular endpoints : first occuring among cardiovascular death, myocardial infarction and stroke
Measured: 2 years
Severe congestive heart failure
Severe congestive heart failure requiring hospitalization, adjudicated by a study outcome committee
Measured: 2 years
Coronary artery disease
Coronary artery disease : myocardial infarction and/or coronary artery revascularizaton
Measured: 2 years
Quality of life EQ-5D3L
Quality of life : assessed by using EQ-5D3L questionnaire
Measured: 2 years
Male/Female lower urinary tract symptoms (LUTS)
Male/Female lower urinary tract symptoms : assessed by using M/F LUTS questionnaire
Measured: 2 years
Safety of the intervention
including : adverse events, foot ulceration requiring medical advise, musculoskeletal disorders, hypoglycemia
Measured: 2 years
Quality of life SF12
Quality of life : assessed by using SF12 questionnaire
Measured: 2 years
Safety of HIPA performed by e-coaching in the context of COVID infection
AE and SAE will be carefully reviewed to assess if the HIPA sessions are safe as performed with e-coaching/ telephone-coaching during lock-down due to the COVID-19 pandemics
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2017
- Study start12 Feb 2018
- Primary completion28 Jul 2023
- Study completion28 Jul 2023
Why it stopped: COVID period
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type2 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 178 participants (actual)
Sponsor and investigators
- Lead sponsor
- Poitiers University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital, Bordeaux, University Hospital, Clermont-Ferrand, Centre Hospitalier Universitaire Dijon, Centre Hospitalier Universitaire de Besancon, Hopital Lariboisière, Bichat Hospital, Centre Hospitalier Sud Francilien, University Hospital, Lille, Centre Hospitalier Universitaire de Nice, University Hospital, Caen, University Hospital, Toulouse, University Hospital, Tours, Nantes University Hospital, Groupe Hospitalier Pitie-Salpetriere, Hospices Civils de Lyon, University Hospital, Montpellier, University Hospital, Strasbourg, Central Hospital, Nancy, France, HOSPITAL, CHARTRES, University of Liege
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03184662
- Sponsor's protocol ID
- ACTIDIANE
- Acronym
- ACTIDIANE
- Status last verified
- Apr 2025
- First submitted
- 26 Apr 2017
- Last updated
- 9 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: sharing policy is under the responsibility of the scientific committee who will organise this point Any request can be posted to the PI in the meantime.
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Trial to Assess the Efficacy of a High-intensity Physical Activity Program on Renal Function Decline in High Risk Patients With Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT03184662
- Acronym / sponsor ID
- ACTIDIANE / ACTIDIANE
- Conditions
- Type2 Diabetes, Diabetic Kidney Disease
- Keywords
- High-intensity physical activity, Diabetes, Renal function decline
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: COVID period
- Enrolment
- 178 participants (actual)
- Lead sponsor
- Poitiers University HospitalUniversity, hospital or other
- Collaborators
- University Hospital, Bordeaux, University Hospital, Clermont-Ferrand, Centre Hospitalier Universitaire Dijon, Centre Hospitalier Universitaire de Besancon, Hopital Lariboisière, Bichat Hospital, Centre Hospitalier Sud Francilien, University Hospital, Lille, Centre Hospitalier Universitaire de Nice, University Hospital, Caen, University Hospital, Toulouse, University Hospital, Tours, Nantes University Hospital, Groupe Hospitalier Pitie-Salpetriere, Hospices Civils de Lyon, University Hospital, Montpellier, University Hospital, Strasbourg, Central Hospital, Nancy, France, HOSPITAL, CHARTRES, University of Liege
- Study start
- 12 Feb 2018 (actual)
- Primary completion
- 28 Jul 2023 (actual)
- Study completion
- 28 Jul 2023 (actual)
- First posted
- 12 Jun 2017 (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 a chronic condition whose prevalence is increasing globally. Kidney disease is a key complication of diabetes and is among the most common cause of end-stage renal disease, requiring renal replacement therapy.
It has been shown that the trajectory of renal function (estimated glomerular filtration rate - eGFR) is of great prognostic value for renal and cardiovascular endpoints in diabetic patients. However the clinical use of this prognostic marker is not associated to date with a clear therapeutic intervention, effective in patients with type 2 diabetes identified with this biomarker.
In France, type 2 diabetes patients have twice less physical activity than non-diabetic persons. Recently, it has been published that physical activity was associated with an improvement of renal risk in patients with type 2 diabetes, recruited from the LOOK-AHEAD study. It was demonstrated that high-intensity physical activity (HIPA) can have several additional advantages over moderate-intensity, on blood pressure improvement, and cardiovascular risk profile modification. In addition, this procedure was shown to be safe in patients with high cardiovascular risk.
We plan to perform a randomized intervention comparing a structured program of high-intensity physical activity (HIPA) vs standard recommendations for physical activity on renal function decline (primary outcome) and mortality, renal and cardiovascular endpoints, patients' safety and quality of life (secondary outcomes). Study participants will be patients with established type 2 diabetes and a high renal risk, identified by rapid renal function decline, defined as a eGFR slope below -5ml/min per 1.73 m2/yr. The intervention is planned to last for 2 years.
Detailed description
I- Visit organisation
V1 (screening) informed consent / examination / inclusion and non-inclusion criteria / medical history M/F LUTS / EPICES score / ECG Serum creatinine determination
V2 (Randomization) examination / verification of participation criteria / randomization Cystatin C collection / Biology Hypoglycemia notification / QAPPA / RPAQ / NAQA / Questionnaires (EQ-5D3L, SF12, Rosenberg Self esteem) / Accelerometer (ancillary) / Impedance-meter (ancillary) 6-minute step test / 10-meter walk test
V3 (1 month) examination / Hypoglycemia notification / QAPPA / RPAQ / Accelerometer (ancillary)
V4 (3 months) examination / Hypoglycemia notification / QAPPA / RPAQ / Questionnaires (EQ-5D3L, SF12, Rosenberg Self esteem) / Accelerometer (ancillary) 6-minute step test Biology
V5 (6 months) examination / Hypoglycemia notification / QAPPA / RPAQ / Questionnaires(EQ-5D3L, SF12, Rosenberg Self esteem) / Accelerometer (ancillary) 6-minute step test Cystatin C collection / Biology
V6 (12 months) examination / Hypoglycemia notification / QAPPA / RPAQ / NAQA / M/F LUTS / Questionnaires(EQ-5D3L, SF12, Rosenberg Self esteem) / ECG /Accelerometer (ancillary) / Impedance-meter (ancillary) Cystatin C collection / Biology 6-minute step test / 10-meter walk test
V7 (18 months) examination / Hypoglycemia notification / QAPPA / RPAQ / Questionnaires(EQ-5D3L, SF12, Rosenberg Self esteem) / Accelerometer (ancillary) Cystatin C collection / Biology 6-minute step test
V8 (24 months) / premature discontinuation examination / Hypoglycemia notification / QAPPA / RPAQ / NAQA / M/F LUTS / Questionnaires (EQ-5D3L, SF12, Rosenberg Self esteem) / ECG / Accelerometer (ancillary) / Impedance-meter (ancillary) 6-minute step test / 10-meter walk test Cystatin C collection / Biology
II- Recruitment criteria Inclusion
- Age : 45 and higher
- Female or male
- Type 2 diabetes with diabetes typing according to widely-accepted clinical and biological criteria [3].
- Subject able to practice physical activity. This includes a normal exercise test with or without anti-ischemic drugs, performed in the preceding 6 months or short before randomization. A certificate of no contre-indication for PA is to be delivered prior to randomization.
- With at least 3 available creatinine measurements in the 6 to 24 preceding months showing a rapid renal function decline defined as an eGFR slope below -5 ml/min/yr
- Estimated GFR equal to or higher than 30 ml/min/1.73m², defined by the CKD-EPI formula, at inclusion visit
Non inclusion
- Age strictly lower than 45 years
- Indication for cardiovascular rehabilitation (notably patient with ischemic heart disease or coronary revascularisation)
- Treatment with systemic NSAIDs or corticosteroids
- Lower limb amputation (above trans-metacarpal)
- Active proliferative retinopathy (risk of bleeding in case of effort)
- Contra-indication for the participation to PA:
- Severe non-operated valvulopathy
- Uncontrolled hypertension > 180/110 mmHg
- Thrombus in the left ventricular cavity
- Unstable coronaropathy, according to physician
- NYHA stage IV heart failure
- Any condition that would jeopardize patient's safety or would affect the conduct of the study
- Pregnant or breast-feeding women or women of child-bearing potential without effective contraception during the study
- Any situation associated with unreliable cystatin-C determinations, according to patient medical history: HIV positivity, melanoma and thyroid dysfunction
- Simultaneous participation to any interventional study able to interfere with the current study endpoints
- Patients not registered to the social security
- Protected adults (under guardianship and trusteeship)
- Subject unable to express their consent (due to intellectual/mental incapacity)
III- Intervention HIPA group Twice weekly physical activity session in a dedicated structure, supervised by a graduated coach, alternating sessions of strengthening and intermittent HIPA, allowing a mixed stimulation of neuro-muscular and cardiovascular systems, and regular (every 3 months) adjustment of the intensity of the program.
Control group Counseling of physical activity according to recommendations from the working group on Physical Activity of the SFD (French Language Diabetes Society) supported by patient's oriented leaflet.
IV- Handling with the COVID-19 pandemics
The COVID-19 pandemics has modified the shape of the study with
- difficulties to comply with the study plan, including recruitment pace. Visits can be postponed if required but investigators are encouraged to follow the initial plan. The time between randomization and V3 (1 month) and V4 (3 months) can sometimes be too short and it is acceptable to perform this visit by phone or even to cancel it.
- difficulties to comply with physical activity (PA) plan. As PA facilities have been locked down in the pandemics context, the sports committee of the ACTIDIANE study has agreed to move attendances to the gym to some remote PA sessions, via websession or if not possible, via telephone coaching sessions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HIPA group | Experimental | Other: HIPATwice weekly physical activity session in a dedicated structure, supervised by a graduated coach, alternating sessions of strengthening and intermittent HIPA, allowing a mixed stimulation of neuro-muscular and cardiovascular systems, and regular (every 3 months) adjustment of the intensity of the program. The sessions will be preferably performed in sports gyms but if required can also be performed online with supervised coaches, trained for the study. |
| Control group | Active comparator | Other: Counseling PACounseling of physical activity according to recommendations from the working group on Physical Activity of the SFD (French Language Diabetes Society). |
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Type 2 diabetes
- Rapid renal decline function (yearly loss of eGFR over -5ml/min/1.73 m2) in the 6 to 24 preceding months
Key exclusion criteria (8 listed)
- Lower limb amputation
- Indication for rehabilitation program
- Contra-indication for physical activity
- Unstable angina, left atrial thrombus,
- Unstable thyroid function
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 |
|---|---|---|
| HIPAinclusion in a program with 2 weekly sessions of structured physical activity of 1 hour in a dedicated structure, under the supervision of a graduated coach. First 3 months : physical reconditioning 3 months and after: alternating sessions of physical strengthening and intermittent high-intensity physical activity Adaptation of the intensity of the program according to evaluation tests every 3 months | Other | HIPA group |
| Counseling PACounseling of physical activity according to recommendations from the working group on Physical Activity of the SFD | Other | Control group |
Primary outcome
Renal Function Decline
Time frame: 2 years
Estimated glomerular filtration rate slope computed within 2 years, evaluated with the cystatin-derived CKD-EPI formula At least 3 available determinations of estimated glomerular filtration rate will be required to perform the calculation of the slope
13 secondary outcomes
Incidence of ESRF
Time frame: 2 years
Number of patients with a decrease in eGRF
Time frame: 2 years
All cause death
Time frame: 2 years
Cardiovascular death
Time frame: 2 years
Renal death
Time frame: 2 years
MACE
Time frame: 2 years
Severe congestive heart failure
Time frame: 2 years
Coronary artery disease
Time frame: 2 years
Quality of life EQ-5D3L
Time frame: 2 years
Male/Female lower urinary tract symptoms (LUTS)
Time frame: 2 years
Safety of the intervention
Time frame: 2 years
Quality of life SF12
Time frame: 2 years
Safety of HIPA performed by e-coaching in the context of COVID infection
Time frame: 2 years
Results and safety
The study was stopped early (reason given: COVID period). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2025.
- Individual participant dataSharing planned: Yes. sharing policy is under the responsibility of the scientific committee who will organise this point Any request can be posted to the PI in the meantime.
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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.
The record lists no contact. Use the official record to reach the sponsor.
20 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HIPA and Counseling PA in people with Type2 Diabetes and Diabetic Kidney Disease, run by Poitiers University Hospital at 20 sites in 2 countries.
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 2 inclusion and 8 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: stopped early, as of the sponsor's last update on 9 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in France, Belgium. 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?
The study was stopped early (reason given: COVID period). 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?
Renal Function Decline (time frame: 2 years). 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 9 Apr 2025.