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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 : January 2, 2018
Sponsor:
Collaborators:
University Hospital, Bordeaux
University Hospital, Clermont-Ferrand
Centre Hospitalier Universitaire Dijon
Centre Hospitalier Universitaire de Besancon
Hopital Lariboisière
Bichat Hospital
Centre Hospitalier Sud Francilien
University Hospital, Lille
Centre Hospitalier Universitaire de Nice
University Hospital, Caen
University Hospital, Toulouse
University Hospital, Tours
Nantes University Hospital
Groupe Hospitalier Pitie-Salpetriere
University Hospital, Lyon
University Hospital, Montpellier
University Hospital, Strasbourg
Central Hospital, Nancy, France
Information provided by (Responsible Party):
Poitiers University Hospital

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.


Condition or disease Intervention/treatment Phase
Type2 Diabetes Diabetic Kidney Disease Other: HIPA Other: Counseling PA Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Estimated Study Start Date : January 2018
Estimated Primary Completion Date : January 2020
Estimated Study Completion Date : June 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.
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


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




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Incidence of ESRF [ Time Frame: 2 years ]
    Incidence of end-stage renal failure requiring renal replacement therapy

  2. 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

  3. All cause death [ Time Frame: 2 years ]
    Number of patients who died during the study (all cause)

  4. Cardiovascular death [ Time Frame: 2 years ]
    Cardiovascular death as proposed by the ICD-10 classification

  5. Renal death [ Time Frame: 2 years ]
    Renal death as defined as a situation where renal replacement therapy could be used but was not applied

  6. MACE [ Time Frame: 2 years ]
    MACE : major adverse cardiovascular endpoints : first occuring among cardiovascular death, myocardial infarction and stroke

  7. Severe congestive heart failure [ Time Frame: 2 years ]
    Severe congestive heart failure requiring hospitalization, adjudicated by a study outcome committee

  8. Coronary artery disease [ Time Frame: 2 years ]
    Coronary artery disease : myocardial infarction and/or coronary artery revascularizaton

  9. Quality of life EQ-5D3L [ Time Frame: 2 years ]
    Quality of life : assessed by using EQ-5D3L questionnaire

  10. Male/Female lower urinary tract symptoms (LUTS) [ Time Frame: 2 years ]
    Male/Female lower urinary tract symptoms : assessed by using M/F LUTS questionnaire

  11. Safety of the intervention [ Time Frame: 2 years ]
    including : adverse events, foot ulceration requiring medical advise, musculoskeletal disorders, hypoglycemia

  12. Quality of life SF12 [ Time Frame: 2 years ]
    Quality of life : assessed by using SF12 questionnaire



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Ages Eligible for Study:   45 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Type 2 diabetes
  • Rapid renal decline function (yearly loss of eGFR over -5ml/min/1.73 m2) in the previous 1 to 5 years

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

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


Contacts
Contact: Samy Hadjadj 00 33 5 49 44 46 89 samy.hadjadj@chu-poitiers.fr

Locations
France
Bordeaux University Hospital Recruiting
Bordeaux, France, 33000
Contact: Vincent Rigalleau         
Clermont Ferrand University Hospital Recruiting
Clermont Ferrand, France, 63000
Contact: Igor Tauveron         
Nantes University Hospital Recruiting
Nantes, France, 44000
Contact: Bertrand Cariou         
Poitiers University Hospital Recruiting
Poitiers, France, 86000
Contact: Samy Hadjadj         
Sponsors and Collaborators
Poitiers University Hospital
University Hospital, Bordeaux
University Hospital, Clermont-Ferrand
Centre Hospitalier Universitaire Dijon
Centre Hospitalier Universitaire de Besancon
Hopital Lariboisière
Bichat Hospital
Centre Hospitalier Sud Francilien
University Hospital, Lille
Centre Hospitalier Universitaire de Nice
University Hospital, Caen
University Hospital, Toulouse
University Hospital, Tours
Nantes University Hospital
Groupe Hospitalier Pitie-Salpetriere
University Hospital, Lyon
University Hospital, Montpellier
University Hospital, Strasbourg
Central Hospital, Nancy, France

Responsible Party: Poitiers University Hospital
ClinicalTrials.gov Identifier: NCT03184662     History of Changes
Other Study ID Numbers: ACTIDIANE
First Posted: June 12, 2017    Key Record Dates
Last Update Posted: January 2, 2018
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: sharing policy is under the responsibility of the scientific committee who will organise this point Any request can be posted to the PI in the meantime.
Time Frame: pending
Access Criteria: pending
URL: https://actidiane.fr

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Poitiers University Hospital:
High-intensity physical activity
Diabetes
Renal function decline

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Kidney Diseases
Diabetic Nephropathies
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Urologic Diseases
Diabetes Complications