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

  • STATUS
    Recruiting
  • End date
    Jul 31, 2023
  • participants needed
    300
  • sponsor
    Poitiers University Hospital
Updated on 24 January 2021
diabetes
type 2 diabetes mellitus
renal failure
glomerular filtration rate
nephropathy
replacement therapy
kidney function tests
kidney replacement

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.

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/1.73m, 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.

Details
Condition Diabetic Nephropathy, Nephropathy, Kidney Disease (Pediatric), Type2 Diabetes, Kidney Disease, Diabetic Kidney Disease
Treatment HIPA, Counseling PA
Clinical Study IdentifierNCT03184662
SponsorPoitiers University Hospital
Last Modified on24 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age greater than or equal to 45 yrs?
Gender: Male or Female
Do you have any of these conditions: Kidney Disease or Diabetic Kidney Disease or Diabetic Nephropathy or Kidney Disease (Pediatric) or Type2 Diabetes or Nephropathy?
Do you have any of these conditions: Diabetic Nephropathy or Kidney Disease or Kidney Disease (Pediatric) or Diabetic Kidney Disease or Nephropathy or Type2 Diabetes?
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
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