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 / Osteoprot g rine (RANKL / OPG) System in Patients Living With Type II Diabetes

  • STATUS
    Recruiting
  • End date
    Aug 1, 2022
  • participants needed
    60
  • sponsor
    Centre Hospitalier Sud Francilien
Updated on 17 July 2021

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).

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 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). The pathophysiology of CN is not completely known but there is an activation of markers of inflammation and bone remodeling, disruption of the osteoblast and osteoclast system, activation of the RANKL system (Receptor activator of nuclear factor-kappa B ligand) and its antagonist osteoprogesterin (OPG). Inflammation and peripheral hypervascularization therefore seem to be a common link between the two pathologies mentioned (NITD and CN). We have confirmation that the rapid correction of chronic hyperglycemia can trigger (not systematically) NITD, but what about the influence of this rapid correction on the appearance of CN. Furthermore, physical activity (PA) and exercise have long been recognized as the cornerstones of the prevention and management of chronic diseases, due to their beneficial effects on the clinical parameters of various diseases. The practice of PA has a preventive and therapeutic effect against osteoporosis (a disease in which the level of RANKL is particularly high), so there is in theory a preventive effect of the practice of physical activity on the development of CN.

Details
Condition NIDDM, type 2 diabetes mellitus, type 2 diabetes, type ii diabetes, noninsulin-dependent diabetes mellitus, diabetes type 2
Treatment pratice physical activity
Clinical Study IdentifierNCT04893135
SponsorCentre Hospitalier Sud Francilien
Last Modified on17 July 2021

Eligibility

Yes No Not Sure

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 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 Criteria

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
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact

site

0/250

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note