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

NCT04893135 | Completed

• 1 other identifier: IDRCB 2021-A00576-35
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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 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).

Conditions

Type II Diabetes

Keywords

Diabetes's complications; neuroarthropathy Physical activity; RNKL/OPG

Outcome Measures

Primary Outcomes (1)

• RANKL/OPG level

  RANKL/OPG level

  at 3 months

Secondary Outcomes (1)

• Sudoscan measurement

  at 3 months

Study Arms (3)

G1A

NO INTERVENTION

Uncontrolled 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

G1B

EXPERIMENTAL

Uncontrolled 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

Other: pratice physical activity

G2

NO INTERVENTION

Controlled diabetes (HbA1c level \<7%). This group will study the natural course of RANKL levels in balanced diabetic patients.

Interventions

pratice physical activity OTHER

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%

G1B

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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
• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Centre Hospitalier Sud Francilien: lead

Study Sites (1)

Centre Hospitalier Sud Francilien

Corbeil-Essonnes, 91100, France

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 14, 2021
• First Posted: May 19, 2021
• Study Start: October 11, 2021
• Primary Completion: October 11, 2022
• Study Completion: October 11, 2022
• Last Updated: February 16, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)