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

April 7, 2025 updated by: Poitiers University Hospital

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
178

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Belgium
      • Liège, Belgium
        • Hospital of Liège
  • France
      • Besançon, France
        • Besançon Hospital
      • Bordeaux, France, 33000
        • Bordeaux University Hospital
      • Caen, France, 14033
        • CAEN University Hospital
      • Chartres, France
        • CH Chartres
      • Clermont Ferrand, France, 63000
        • Clermont ferrand University hospital
      • Corbeil-Essonnes, France, 91100
        • CHG Sud Francilien
      • Dijon, France, 21000
        • CHU Dijon
      • Lille, France, 59000
        • CHU Lille
      • Lyon, France, 69229
        • CHU de Lyon
      • Montpellier, France
        • CHRU
      • Nancy, France, 54000
        • CHU Nancy
      • Nice, France, 06003
        • CHU de Nice
      • Paris, France, 75651
        • Hopital Pitie Salpetriere
      • Paris, France, 75000
        • Bichat University Hospital
      • Paris, France, 75000
        • La Riboisière Hospital
      • Poitiers, France, 86000
        • Poitiers University Hospital
      • Strasbourg, France, 67000
        • CHU Strasbourg
      • Toulouse, France, 31000
        • CHU Toulouse
      • Tours, France, 37044
        • CHU de TOURS

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

45 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.

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

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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
2 years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Incidence of ESRF
Time Frame: 2 years
Incidence of end-stage renal failure requiring renal replacement therapy
2 years
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
2 years
All cause death
Time Frame: 2 years
Number of patients who died during the study (all cause)
2 years
Cardiovascular death
Time Frame: 2 years
Cardiovascular death as proposed by the ICD-10 classification
2 years
Renal death
Time Frame: 2 years
Renal death as defined as a situation where renal replacement therapy could be used but was not applied
2 years
MACE
Time Frame: 2 years
MACE : major adverse cardiovascular endpoints : first occuring among cardiovascular death, myocardial infarction and stroke
2 years
Severe congestive heart failure
Time Frame: 2 years
Severe congestive heart failure requiring hospitalization, adjudicated by a study outcome committee
2 years
Coronary artery disease
Time Frame: 2 years
Coronary artery disease : myocardial infarction and/or coronary artery revascularizaton
2 years
Quality of life EQ-5D3L
Time Frame: 2 years
Quality of life : assessed by using EQ-5D3L questionnaire
2 years
Male/Female lower urinary tract symptoms (LUTS)
Time Frame: 2 years
Male/Female lower urinary tract symptoms : assessed by using M/F LUTS questionnaire
2 years
Safety of the intervention
Time Frame: 2 years
including : adverse events, foot ulceration requiring medical advise, musculoskeletal disorders, hypoglycemia
2 years
Quality of life SF12
Time Frame: 2 years
Quality of life : assessed by using SF12 questionnaire
2 years
Safety of HIPA performed by e-coaching in the context of COVID infection
Time Frame: 2 years
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
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Poitiers University Hospital

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Hospices Civils de Lyon
Centre Hospitalier Universitaire Dijon
University Hospital, Montpellier
Central Hospital, Nancy, France
University Hospital, Bordeaux
University of Liege
University Hospital, Clermont-Ferrand
University Hospital, Caen
Centre Hospitalier Universitaire de Nice
Centre Hospitalier Universitaire de Besancon
University Hospital, Toulouse
University Hospital, Lille
Nantes University Hospital
Groupe Hospitalier Pitie-Salpetriere
Centre Hospitalier Sud Francilien
University Hospital, Tours
Hopital Lariboisière
University Hospital, Strasbourg
Bichat Hospital
HOSPITAL, CHARTRES

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 12, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 28, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 28, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 26, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 9, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 12, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 9, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 7, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ACTIDIANE

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD 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

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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