Efficacy of a High-intensity Physical Activity Program on Renal Function in High Risk Patients With Type 2 Diabetes (ACTIDIANE)
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|ClinicalTrials.gov Identifier: NCT03184662|
Recruitment Status : Recruiting
First Posted : June 12, 2017
Last Update Posted : March 30, 2020
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.
|Condition or disease||Intervention/treatment||Phase|
|Type2 Diabetes Diabetic Kidney Disease||Other: HIPA Other: Counseling PA||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||300 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
|Actual Study Start Date :||February 12, 2018|
|Estimated Primary Completion Date :||July 31, 2022|
|Estimated Study Completion Date :||July 31, 2023|
Experimental: 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.
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
Active Comparator: Control group
Counseling of physical activity according to recommendations from the working group on Physical Activity of the SFD (French Language Diabetes Society).
Other: Counseling PA
Counseling of physical activity according to recommendations from the working group on Physical Activity of the SFD
- 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
- Incidence of ESRF [ Time Frame: 2 years ]Incidence of end-stage renal failure requiring renal replacement therapy
- Number of patients with a decrease in eGRF [ Time Frame: 2 years ]Number of patients with a decrease in eGRF greater than 40% of baseline value
- All cause death [ Time Frame: 2 years ]Number of patients who died during the study (all cause)
- Cardiovascular death [ Time Frame: 2 years ]Cardiovascular death as proposed by the ICD-10 classification
- Renal death [ Time Frame: 2 years ]Renal death as defined as a situation where renal replacement therapy could be used but was not applied
- MACE [ Time Frame: 2 years ]MACE : major adverse cardiovascular endpoints : first occuring among cardiovascular death, myocardial infarction and stroke
- Severe congestive heart failure [ Time Frame: 2 years ]Severe congestive heart failure requiring hospitalization, adjudicated by a study outcome committee
- Coronary artery disease [ Time Frame: 2 years ]Coronary artery disease : myocardial infarction and/or coronary artery revascularizaton
- Quality of life EQ-5D3L [ Time Frame: 2 years ]Quality of life : assessed by using EQ-5D3L questionnaire
- Male/Female lower urinary tract symptoms (LUTS) [ Time Frame: 2 years ]Male/Female lower urinary tract symptoms : assessed by using M/F LUTS questionnaire
- Safety of the intervention [ Time Frame: 2 years ]including : adverse events, foot ulceration requiring medical advise, musculoskeletal disorders, hypoglycemia
- Quality of life SF12 [ Time Frame: 2 years ]Quality of life : assessed by using SF12 questionnaire
- Safety of HIPA performed by e-coaching in the context of COVID infection [ Time Frame: 6 months ]AE and SAE will be carefully reviewed to assess if the HIPA as performed with e-coaching during lock-in due to the COVID pandemics is safe
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03184662
|Contact: Samy Hadjadj||00 33 253 48 27 email@example.com|