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

NCT03184662 | Terminated DMC

• 1 other identifier: ACTIDIANE
• Study Type: interventional
• Target: 178
• Locations: 2 countries
• Sites: 20

Brief 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

Keywords

High-intensity physical activity; Diabetes; Renal function decline

Outcome Measures

Primary Outcomes (1)

• 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

  2 years

Secondary Outcomes (13)

• Incidence of ESRF

  2 years

• Number of patients with a decrease in eGRF

  2 years

• All cause death

  2 years

• Cardiovascular death

  2 years

• Renal death

  2 years

Study Arms (2)

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.

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).

Other: Counseling PA

Interventions

HIPA OTHER

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

HIPA group

Counseling PA OTHER

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

Control group

Eligibility Criteria

• Age: 45 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Type 2 diabetes
• Rapid renal decline function (yearly loss of eGFR over -5ml/min/1.73 m2) in the 6 to 24 preceding months

You may not qualify if:

• 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

Sponsors & Collaborators

• Poitiers University Hospital: lead
• University Hospital, Bordeaux: collaborator
• University Hospital, Clermont-Ferrand: collaborator
• Centre Hospitalier Universitaire Dijon: collaborator
• Centre Hospitalier Universitaire de Besancon: collaborator
• Hopital Lariboisière: collaborator
• Bichat Hospital: collaborator
• Centre Hospitalier Sud Francilien: collaborator
• University Hospital, Lille: collaborator
• Centre Hospitalier Universitaire de Nice: collaborator
• University Hospital, Caen: collaborator
• University Hospital, Toulouse: collaborator
• University Hospital, Tours: collaborator
• Nantes University Hospital: collaborator
• Groupe Hospitalier Pitie-Salpetriere: collaborator
• Hospices Civils de Lyon: collaborator
• University Hospital, Montpellier: collaborator
• University Hospital, Strasbourg: collaborator
• Central Hospital, Nancy, France: collaborator
• HOSPITAL, CHARTRES: collaborator
• University of Liege: collaborator

Study Sites (20)

Hospital of Liège

Liège, Belgium

Location

Besançon Hospital

Besançon, France

Location

Bordeaux University Hospital

Bordeaux, 33000, France

Location

Caen University Hospital

Caen, 14033, France

Location

CH Chartres

Chartres, France

Location

Clermont Ferrand University Hospital

Clermont-Ferrand, 63000, France

Location

CHG Sud Francilien

Corbeil-Essonnes, 91100, France

Location

CHU Dijon

Dijon, 21000, France

Location

CHU Lille

Lille, 59000, France

Location

Chu de Lyon

Lyon, 69229, France

Location

CHRU

Montpellier, France

Location

CHU Nancy

Nancy, 54000, France

Location

Chu de Nice

Nice, 06003, France

Location

Bichat University Hospital

Paris, 75000, France

Location

La Riboisière Hospital

Paris, 75000, France

Location

Hôpital Pitié Salpétrière

Paris, 75651, France

Location

Poitiers University Hospital

Poitiers, 86000, France

Location

CHU Strasbourg

Strasbourg, 67000, France

Location

CHU Toulouse

Toulouse, 31000, France

Location

CHU de TOURS

Tours, 37044, France

Location

MeSH Terms

Conditions

Diabetic Nephropathies; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Diabetes Complications; Endocrine System Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 26, 2017
• First Posted: June 12, 2017
• Study Start: February 12, 2018
• Primary Completion: July 28, 2023
• Study Completion: July 28, 2023
• Last Updated: April 9, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share
• Time Frame: pending
• Access Criteria: pending

Locations

BE (1); FR (19)