CompletedNot Applicable

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

France60 participantsStarted 2021-10-11

Plain-language 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 contact with the nerve ends. In another register in patients living with diabetes, it has been observed the development of a rare and devastating complication for the joints called the so-called neuroarthropathy of Charcot (CN).

Who can participate

Age range

18 Years – 70 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: 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…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

RANKL/OPG level

Timeframe: at 3 months

Trial details

NCT IDNCT04893135

SponsorCentre Hospitalier Sud Francilien

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-10-11

View on ClinicalTrials.gov More Type II Diabetes trials