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

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.

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.

Conditions

• Type2 Diabetes
• Diabetic Kidney Disease

Interventions

OTHER

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

OTHER

Counseling PA

Counseling of physical activity according to recommendations from the working group on Physical Activity of the SFD

Sponsors & Collaborators

• University Hospital, Bordeaux

  collaborator OTHER

• University Hospital, Clermont-Ferrand

  collaborator OTHER

• Centre Hospitalier Universitaire Dijon

  collaborator OTHER

• Centre Hospitalier Universitaire de Besancon

  collaborator OTHER

• Hopital Lariboisière

  collaborator OTHER

• Bichat Hospital

  collaborator OTHER

• Centre Hospitalier Sud Francilien

  collaborator OTHER

• University Hospital, Lille

  collaborator OTHER

• Centre Hospitalier Universitaire de Nice

  collaborator OTHER

• University Hospital, Caen

  collaborator OTHER

• University Hospital, Toulouse

  collaborator OTHER

• University Hospital, Tours

  collaborator OTHER

• Nantes University Hospital

  collaborator OTHER

• Groupe Hospitalier Pitie-Salpetriere

  collaborator OTHER

• Hospices Civils de Lyon

  collaborator OTHER

• University Hospital, Montpellier

  collaborator OTHER

• University Hospital, Strasbourg

  collaborator OTHER

• Central Hospital, Nancy, France

  collaborator OTHER

• HOSPITAL, CHARTRES

  collaborator UNKNOWN

• University of Liege

  collaborator OTHER

• Poitiers University Hospital

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

45 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2018-02-12

Primary Completion

2023-07-28

Completion

2023-07-28

Countries

• Belgium
• France

Study Locations