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

Primary Purpose

Type2 Diabetes, Diabetic Kidney Disease

Status
Recruiting
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
HIPA
Counseling PA
Sponsored by
Poitiers University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type2 Diabetes focused on measuring High-intensity physical activity, Diabetes, Renal function decline

Eligibility Criteria

45 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

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
  • Simultaneous participation to any interventional study able to interfere with the current study endpoints

Sites / Locations

  • Hospital of LiègeRecruiting
  • Besançon HospitalRecruiting
  • Bordeaux University HospitalRecruiting
  • Caen University HospitalRecruiting
  • CH ChartresRecruiting
  • Clermont Ferrand University HospitalRecruiting
  • CHG Sud FrancilienRecruiting
  • CHU DijonRecruiting
  • CHU LilleRecruiting
  • Chu de LyonRecruiting
  • CHRURecruiting
  • CHU NancyRecruiting
  • Chu de NiceRecruiting
  • Bichat University HospitalRecruiting
  • La Riboisière HospitalRecruiting
  • Hôpital Pitié SalpétrièreRecruiting
  • Poitiers University HospitalRecruiting
  • CHU StrasbourgRecruiting
  • CHU ToulouseRecruiting
  • CHU de TOURSRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

HIPA group

Control group

Arm Description

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.

Counseling of physical activity according to recommendations from the working group on Physical Activity of the SFD (French Language Diabetes Society).

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Incidence of ESRF
Incidence of end-stage renal failure requiring renal replacement therapy
Number of patients with a decrease in eGRF
Number of patients with a decrease in eGRF greater than 40% of baseline value
All cause death
Number of patients who died during the study (all cause)
Cardiovascular death
Cardiovascular death as proposed by the ICD-10 classification
Renal death
Renal death as defined as a situation where renal replacement therapy could be used but was not applied
MACE
MACE : major adverse cardiovascular endpoints : first occuring among cardiovascular death, myocardial infarction and stroke
Severe congestive heart failure
Severe congestive heart failure requiring hospitalization, adjudicated by a study outcome committee
Coronary artery disease
Coronary artery disease : myocardial infarction and/or coronary artery revascularizaton
Quality of life EQ-5D3L
Quality of life : assessed by using EQ-5D3L questionnaire
Male/Female lower urinary tract symptoms (LUTS)
Male/Female lower urinary tract symptoms : assessed by using M/F LUTS questionnaire
Safety of the intervention
including : adverse events, foot ulceration requiring medical advise, musculoskeletal disorders, hypoglycemia
Quality of life SF12
Quality of life : assessed by using SF12 questionnaire
Safety of HIPA performed by e-coaching in the context of COVID infection
AE and SAE will be carefully reviewed to assess if the HIPA sessions are safe as performed with e-coaching/ telephone-coaching during lock-down due to the COVID-19 pandemics

Full Information

First Posted
April 26, 2017
Last Updated
January 29, 2021
Sponsor
Poitiers University Hospital
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, Hospices Civils de Lyon, University Hospital, Montpellier, University Hospital, Strasbourg, Central Hospital, Nancy, France, HOSPITAL, CHARTRES, University of Liege
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1. Study Identification

Unique Protocol Identification Number
NCT03184662
Brief Title
Efficacy of a High-intensity Physical Activity Program on Renal Function in High Risk Patients With Type 2 Diabetes
Acronym
ACTIDIANE
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Recruiting
Study Start Date
February 12, 2018 (Actual)
Primary Completion Date
September 30, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Poitiers University Hospital
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, Hospices Civils de Lyon, University Hospital, Montpellier, University Hospital, Strasbourg, Central Hospital, Nancy, France, HOSPITAL, CHARTRES, University of Liege

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
I- Visit organisation V1 (screening) informed consent / examination / inclusion and non-inclusion criteria / medical history M/F LUTS / EPICES score / ECG Serum creatinine determination V2 (Randomization) examination / verification of participation criteria / randomization Cystatin C collection / Biology Hypoglycemia notification / QAPPA / RPAQ / NAQA / Questionnaires (EQ-5D3L, SF12, Rosenberg Self esteem) / Accelerometer (ancillary) / Impedance-meter (ancillary) 6-minute step test / 10-meter walk test V3 (1 month) examination / Hypoglycemia notification / QAPPA / RPAQ / Accelerometer (ancillary) V4 (3 months) examination / Hypoglycemia notification / QAPPA / RPAQ / Questionnaires (EQ-5D3L, SF12, Rosenberg Self esteem) / Accelerometer (ancillary) 6-minute step test Biology V5 (6 months) examination / Hypoglycemia notification / QAPPA / RPAQ / Questionnaires(EQ-5D3L, SF12, Rosenberg Self esteem) / Accelerometer (ancillary) 6-minute step test Cystatin C collection / Biology V6 (12 months) examination / Hypoglycemia notification / QAPPA / RPAQ / NAQA / M/F LUTS / Questionnaires(EQ-5D3L, SF12, Rosenberg Self esteem) / ECG /Accelerometer (ancillary) / Impedance-meter (ancillary) Cystatin C collection / Biology 6-minute step test / 10-meter walk test V7 (18 months) examination / Hypoglycemia notification / QAPPA / RPAQ / Questionnaires(EQ-5D3L, SF12, Rosenberg Self esteem) / Accelerometer (ancillary) Cystatin C collection / Biology 6-minute step test V8 (24 months) / premature discontinuation examination / Hypoglycemia notification / QAPPA / RPAQ / NAQA / M/F LUTS / Questionnaires (EQ-5D3L, SF12, Rosenberg Self esteem) / ECG / Accelerometer (ancillary) / Impedance-meter (ancillary) 6-minute step test / 10-meter walk test Cystatin C collection / Biology II- Recruitment criteria Inclusion Age : 45 and higher Female or male Type 2 diabetes with diabetes typing according to widely-accepted clinical and biological criteria [3]. Subject able to practice physical activity. This includes a normal exercise test with or without anti-ischemic drugs, performed in the preceding 6 months or short before randomization. A certificate of no contre-indication for PA is to be delivered prior to randomization. With at least 3 available creatinine measurements in the 6 to 24 preceding months showing a rapid renal function decline defined as an eGFR slope below -5 ml/min/yr Estimated GFR equal to or higher than 30 ml/min/1.73m², defined by the CKD-EPI formula, at inclusion visit Non inclusion Age strictly lower than 45 years Indication for cardiovascular rehabilitation (notably patient with ischemic heart disease or coronary revascularisation) Treatment with systemic NSAIDs or corticosteroids Lower limb amputation (above trans-metacarpal) Active proliferative retinopathy (risk of bleeding in case of effort) Contra-indication for the participation to PA: Severe non-operated valvulopathy Uncontrolled hypertension > 180/110 mmHg Thrombus in the left ventricular cavity Unstable coronaropathy, according to physician NYHA stage IV heart failure Any condition that would jeopardize patient's safety or would affect the conduct of the study Pregnant or breast-feeding women or women of child-bearing potential without effective contraception during the study Any situation associated with unreliable cystatin-C determinations, according to patient medical history: HIV positivity, melanoma and thyroid dysfunction Simultaneous participation to any interventional study able to interfere with the current study endpoints Patients not registered to the social security Protected adults (under guardianship and trusteeship) Subject unable to express their consent (due to intellectual/mental incapacity) III- Intervention 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. Control group Counseling of physical activity according to recommendations from the working group on Physical Activity of the SFD (French Language Diabetes Society) supported by patient's oriented leaflet. IV- Handling with the COVID-19 pandemics The COVID-19 pandemics has modified the shape of the study with difficulties to comply with the study plan, including recruitment pace. Visits can be postponed if required but investigators are encouraged to follow the initial plan. The time between randomization and V3 (1 month) and V4 (3 months) can sometimes be too short and it is acceptable to perform this visit by phone or even to cancel it. difficulties to comply with physical activity (PA) plan. As PA facilities have been locked down in the pandemics context, the sports committee of the ACTIDIANE study has agreed to move attendances to the gym to some remote PA sessions, via websession or if not possible, via telephone coaching sessions.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type2 Diabetes, Diabetic Kidney Disease
Keywords
High-intensity physical activity, Diabetes, Renal function decline

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
HIPA group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control group
Arm Type
Active Comparator
Arm Description
Counseling of physical activity according to recommendations from the working group on Physical Activity of the SFD (French Language Diabetes Society).
Intervention Type
Other
Intervention Name(s)
HIPA
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
Counseling PA
Intervention Description
Counseling of physical activity according to recommendations from the working group on Physical Activity of the SFD
Primary Outcome Measure Information:
Title
Renal Function Decline
Description
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
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Incidence of ESRF
Description
Incidence of end-stage renal failure requiring renal replacement therapy
Time Frame
2 years
Title
Number of patients with a decrease in eGRF
Description
Number of patients with a decrease in eGRF greater than 40% of baseline value
Time Frame
2 years
Title
All cause death
Description
Number of patients who died during the study (all cause)
Time Frame
2 years
Title
Cardiovascular death
Description
Cardiovascular death as proposed by the ICD-10 classification
Time Frame
2 years
Title
Renal death
Description
Renal death as defined as a situation where renal replacement therapy could be used but was not applied
Time Frame
2 years
Title
MACE
Description
MACE : major adverse cardiovascular endpoints : first occuring among cardiovascular death, myocardial infarction and stroke
Time Frame
2 years
Title
Severe congestive heart failure
Description
Severe congestive heart failure requiring hospitalization, adjudicated by a study outcome committee
Time Frame
2 years
Title
Coronary artery disease
Description
Coronary artery disease : myocardial infarction and/or coronary artery revascularizaton
Time Frame
2 years
Title
Quality of life EQ-5D3L
Description
Quality of life : assessed by using EQ-5D3L questionnaire
Time Frame
2 years
Title
Male/Female lower urinary tract symptoms (LUTS)
Description
Male/Female lower urinary tract symptoms : assessed by using M/F LUTS questionnaire
Time Frame
2 years
Title
Safety of the intervention
Description
including : adverse events, foot ulceration requiring medical advise, musculoskeletal disorders, hypoglycemia
Time Frame
2 years
Title
Quality of life SF12
Description
Quality of life : assessed by using SF12 questionnaire
Time Frame
2 years
Title
Safety of HIPA performed by e-coaching in the context of COVID infection
Description
AE and SAE will be carefully reviewed to assess if the HIPA sessions are safe as performed with e-coaching/ telephone-coaching during lock-down due to the COVID-19 pandemics
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Type 2 diabetes Rapid renal decline function (yearly loss of eGFR over -5ml/min/1.73 m2) in the 6 to 24 preceding months 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 Simultaneous participation to any interventional study able to interfere with the current study endpoints
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Samy Hadjadj
Phone
00 33 253 48 27 01
Email
samy.hadjadj@gmail.com
Facility Information:
Facility Name
Hospital of Liège
City
Liège
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nicolas Paquot
Facility Name
Besançon Hospital
City
Besançon
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sophie Borot
Facility Name
Bordeaux University Hospital
City
Bordeaux
ZIP/Postal Code
33000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vincent Rigalleau, MD PHD
Facility Name
Caen University Hospital
City
Caen
ZIP/Postal Code
14033
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yves REZNIK, MD PHD
Facility Name
CH Chartres
City
Chartres
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Arnaud Monier
Facility Name
Clermont Ferrand University Hospital
City
Clermont Ferrand
ZIP/Postal Code
63000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Igor Tauveron, MD PHD
Facility Name
CHG Sud Francilien
City
Corbeil-Essonnes
ZIP/Postal Code
91100
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alfred Pernformis, MD PHD
Facility Name
CHU Dijon
City
Dijon
ZIP/Postal Code
21000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bruno Vergès
Facility Name
CHU Lille
City
Lille
ZIP/Postal Code
59000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pierre Fontaine
Facility Name
Chu de Lyon
City
Lyon
ZIP/Postal Code
69229
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Philippe Moulin, MD
Facility Name
CHRU
City
Montpellier
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ariane Sultan, MD PHD
Facility Name
CHU Nancy
City
Nancy
ZIP/Postal Code
54000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Philip Bohme, MD PHD
Facility Name
Chu de Nice
City
Nice
ZIP/Postal Code
06003
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nicolas Chevalier, MD PHD
Facility Name
Bichat University Hospital
City
Paris
ZIP/Postal Code
75000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ronan Roussel, MD-PHD
Facility Name
La Riboisière Hospital
City
Paris
ZIP/Postal Code
75000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jean-François Gautier
Facility Name
Hôpital Pitié Salpétrière
City
Paris
ZIP/Postal Code
75651
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Agnès Hartemann, MD PHD
Facility Name
Poitiers University Hospital
City
Poitiers
ZIP/Postal Code
86000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pierre-Jean Saulnier, MD PHD
Facility Name
CHU Strasbourg
City
Strasbourg
ZIP/Postal Code
67000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nathalie Jeandidier
Facility Name
CHU Toulouse
City
Toulouse
ZIP/Postal Code
31000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pierre Gourdy
Facility Name
CHU de TOURS
City
Tours
ZIP/Postal Code
37044
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pierre-Henri Ducluzeau, MD PHD

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.
IPD Sharing Time Frame
pending
IPD Sharing Access Criteria
pending
IPD Sharing URL
https://actidiane.fr

Learn more about this trial

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

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