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Type II DiabetesRANKL-GLYCNCT04893135

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

A study testing pratice physical activity in people with Type II Diabetes, run by Centre Hospitalier Sud Francilien at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Type II Diabetes
What is being tested?
pratice physical activity
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteFrance
Study dates
11 Oct 2021to 11 Oct 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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).

Who cannot join

  • 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)
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  • 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.

Trial locations and contacts

1 site in 1 country.

France1 site

  • Centre Hospitalier Sud Francilien

    Corbeil-Essonnes, France, 91100

Other trials in France

About this study

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).

Read the 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 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.

Being tested
pratice physical activity
Keywords
Diabetes's complications, neuroarthropathy Physical activity, RNKL/OPG
Medical subject headings
Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • pratice physical activityOther

    treadmill walking : walk at a speed of 2.7 km.h-1 in 3 stages of 3 mins with an incline of 0%, 5% and 10%

Study groups in NCT04893135
Study groupRoleWhat they receive
G1ANo interventionUncontrolled diabetes (HbA1c> 8.5%) over 6 months. In order to assess the effect of rapid correction of HbA1c on RANKL levels, without the practice physical activity
G1BExperimentalUncontrolled diabetes (HbA1c> 8.5%) over 6 months. In order to assess the effect of rapid correction of HbA1c on RANKL levels, with the practice physical activity
Receives: Other: pratice physical activity
G2No interventionControlled diabetes (HbA1c level <7%). This group will study the natural course of RANKL levels in balanced diabetic patients.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. RANKL/OPG level

    RANKL/OPG level

    Measured: at 3 months

Secondary outcomes (1)

  1. Sudoscan measurement

    The Sudoscan non-invasively measures the ability of sweat glands to release chloride ions in response to an electrochemical stimulus on the palms of the hands and soles of the feet, areas with the highest density of sweat glands using four independent electrodes placed on the palms of the hands, soles of the feet which have a high density of sweat glands,

    Measured: at 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 May 2021
  2. Study start11 Oct 2021
  3. Primary completion11 Oct 2022
  4. Study completion11 Oct 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04893135
Sponsor's protocol ID
2021-A00576-35
Acronym
RANKL-GLYC
Status last verified
May 2026
First submitted
14 May 2021
Last updated
26 May 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Dardari D, Van GH, M'Bemba J, Laborne FX, Bourron O, Davaine JM, Phan F, Foufelle F, Jaisser F, Penfornis A, Hartemann A. Rapid glycemic regulation in poorly controlled patients living with diabetes, a new associated factor in the pathophysiology of Charcot's acute neuroarthropathy. PLoS One. 2020 May 21;15(5):e0233168. doi: 10.1371/journal.pone.0233168. eCollection 2020.

    PubMed 32437409

  • Dardari D, Laborne FX, Thomas C, Tourte C, Henry E, Lopes P. Rapid improvement in glycaemic control is associated with increased circulating osteocalcin in type 2 diabetes: a concise observational comparative study. BMC Endocr Disord. 2026 Apr 16;26(1):163. doi: 10.1186/s12902-026-02277-z.

    PubMed 41992221

Questions about this trial

What is this clinical trial studying?

A study testing pratice physical activity in people with Type II Diabetes, run by Centre Hospitalier Sud Francilien at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 18 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

RANKL/OPG level (time frame: at 3 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04893135, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 May 2026.

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