Who is sponsoring ACTIDIANE?

ACTIDIANE is sponsored by Poitiers University Hospital.

What condition does ACTIDIANE study?

ACTIDIANE studies Type2 Diabetes, Diabetic Kidney Disease.

What drugs are being tested in ACTIDIANE?

Interventions: HIPA, Counseling PA.

What is the status of ACTIDIANE?

ACTIDIANE is currently TERMINATED.

Last reviewed 2025-04-09 · How we verify

Efficacy of a High-intensity Physical Activity Program on Renal Function in High Risk Patients With Type 2 Diabetes (ACTIDIANE)

NCT03184662 NA TERMINATED

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.

Details

Lead sponsor	Poitiers University Hospital
Phase	NA
Status	TERMINATED
Enrolment	178
Start date	Mon Feb 12 2018 00:00:00 GMT+0000 (Coordinated Universal Time)
Completion	Fri Jul 28 2023 00:00:00 GMT+0000 (Coordinated Universal Time)

Conditions

Type2 Diabetes
Diabetic Kidney Disease

Interventions

HIPA
Counseling PA

Countries

Belgium, France