Efficacy of a High-intensity Physical Activity Program on Renal Function in High Risk Patients With Type 2 Diabetes
NCT ID: NCT03184662
Last Updated: 2025-04-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
NA
178 participants
INTERVENTIONAL
2018-02-12
2023-07-28
Brief Summary
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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.
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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.
The sessions will be preferably performed in sports gyms but if required can also be performed online with supervised coaches, trained for the study.
HIPA
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
Control group
Counseling of physical activity according to recommendations from the working group on Physical Activity of the SFD (French Language Diabetes Society).
Counseling PA
Counseling of physical activity according to recommendations from the working group on Physical Activity of the SFD
Interventions
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HIPA
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 PA
Counseling of physical activity according to recommendations from the working group on Physical Activity of the SFD
Eligibility Criteria
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Inclusion Criteria
* Rapid renal decline function (yearly loss of eGFR over -5ml/min/1.73 m2) in the 6 to 24 preceding months
Exclusion Criteria
* 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
45 Years
ALL
No
Sponsors
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University Hospital, Bordeaux
OTHER
University Hospital, Clermont-Ferrand
OTHER
Centre Hospitalier Universitaire Dijon
OTHER
Centre Hospitalier Universitaire de Besancon
OTHER
Hopital Lariboisière
OTHER
Bichat Hospital
OTHER
Centre Hospitalier Sud Francilien
OTHER
University Hospital, Lille
OTHER
Centre Hospitalier Universitaire de Nice
OTHER
University Hospital, Caen
OTHER
University Hospital, Toulouse
OTHER
University Hospital, Tours
OTHER
Nantes University Hospital
OTHER
Groupe Hospitalier Pitie-Salpetriere
OTHER
Hospices Civils de Lyon
OTHER
University Hospital, Montpellier
OTHER
University Hospital, Strasbourg
OTHER
Central Hospital, Nancy, France
OTHER
HOSPITAL, CHARTRES
UNKNOWN
University of Liege
OTHER
Poitiers University Hospital
OTHER
Responsible Party
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Locations
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Hospital of Liège
Liège, , Belgium
Besançon Hospital
Besançon, , France
Bordeaux University Hospital
Bordeaux, , France
Caen University Hospital
Caen, , France
CH Chartres
Chartres, , France
Clermont Ferrand University Hospital
Clermont-Ferrand, , France
CHG Sud Francilien
Corbeil-Essonnes, , France
CHU Dijon
Dijon, , France
CHU Lille
Lille, , France
Chu de Lyon
Lyon, , France
CHRU
Montpellier, , France
CHU Nancy
Nancy, , France
Chu de Nice
Nice, , France
Bichat University Hospital
Paris, , France
La Riboisière Hospital
Paris, , France
Hôpital Pitié Salpétrière
Paris, , France
Poitiers University Hospital
Poitiers, , France
CHU Strasbourg
Strasbourg, , France
CHU Toulouse
Toulouse, , France
CHU de TOURS
Tours, , France
Countries
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Other Identifiers
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ACTIDIANE
Identifier Type: -
Identifier Source: org_study_id
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