Status:
COMPLETED
Impact of the Rapid Normalization of Chronic Hyperglycemia and the Practice of Moderate Physical Activity on the "Receptor Activator of Nuclear Factor-kappa B Ligand / Osteoprotégérine (RANKL / OPG) System in Patients Living With Type II Diabetes
Lead Sponsor:
Centre Hospitalier Sud Francilien
Conditions:
Type II Diabetes
Eligibility:
All Genders
18-70 years
Phase:
NA
Brief Summary
The rapid normalization of hyperglycemia can cause a neuropathy called Diabetes Treatment-Induced Neuropathy (NITD). This phenomenon induces the presence of hyper vascularization and inflammation in c...
Detailed Description
The rapid normalization of hyperglycemia can cause a neuropathy called Diabetes Treatment-Induced Neuropathy (NITD). This phenomenon induces the presence of hyper vascularization and inflammation in c...
Eligibility Criteria
Inclusion
- Group G1:
- Male or female patient aged 18 to 70, not practicing regular physical activity (Baecke score \<10)
- Patient with type 2 diabetes for at least 1 year
- Patient treated with metformin +/- SU +/- DPP4 inhibitor +/- GLP1 analogue +/- insulin therapy
- Patient insufficiently balanced under his current treatment with an HbA1c level\> 8.5% for 6 months.
- Patient able to practice physical activity on a regular basis
- Patient having performed a coronary artery disease screening test in the year prior to inclusion
- Woman of childbearing age with effective contraception put in place and monitored throughout the trial
- Patient having given his consent to participate in the study and having signed an informed consent
- Within the G1 group, a controlled 1: 1 randomization, stratified on age (≤65 years or\> 65 years) and BMI (≤ 30 or\> 30) will determine the inclusion of patients in the G1A group (correction of HbA1c) or G1B (correction of HbA1c + physical activity).
- Group G2:
- Male or female patient aged 18 to 70, not practicing regular physical activity
- Patient with type 2 diabetes for at least 1 year
- Patient treated with metformin +/- SU +/- DPP4 inhibitor +/- GLP1 analogue +/- insulin therapy
- Patient balanced under his current treatment with an HbA1c level \<7% for 6 months.
- Women of childbearing potential with effective contraception put in place and monitored throughout the trial
- Patient having given his consent to participate in the study and having signed an informed consent
- Matching with the last patient included in group G1 on age (± 5 years), sex, duration of diabetes (± 2 years) and BMI (± 2kg / m2).
Exclusion
- Fetal and maternal pathologies requiring maturation Patient with type 1 diabetes
- Patient with regular physical activity
- History of severe cardiovascular pathologies (myocardial infarction, or acute coronary syndrome, or stroke in the past year)
- Patient with a history of severe hypoglycemia in the 6 months preceding entry into the study and / or not experiencing hypoglycemia at all
- Patient pregnant or likely to be
- Severe obesity (BMI\> 35kg / m2)
- Other pathologies likely to interfere with the glycemic variation: in particular the use of corticosteroids during the study
- Patient already having Charcot's neuroarthropathy or symptomatic autonomic neuropathy: orthostatic hypotension and / or gastro-paresis
- Patient with preproliferative diabetic retinopathy
- Patient having anti RANKL treatment
- Subject under tutorship or curatorship
- Subject not affiliated to social security.
Key Trial Info
Start Date :
October 11 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 11 2022
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT04893135
Start Date
October 11 2021
End Date
October 11 2022
Last Update
February 16 2023
Active Locations (1)
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1
Centre Hospitalier Sud Francilien
Corbeil-Essonnes, France, 91100