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.