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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 (RANKL-GLYC)

Primary Purpose

Type II Diabetes

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
pratice physical activity
Sponsored by
Centre Hospitalier Sud Francilien
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type II Diabetes focused on measuring Diabetes's complications, neuroarthropathy Physical activity, RNKL/OPG

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Centre Hospitalier Sud Francilien

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Experimental

No Intervention

Arm Label

G1A

G1B

G2

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

RANKL/OPG level
RANKL/OPG level

Secondary Outcome Measures

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,

Full Information

First Posted
May 14, 2021
Last Updated
February 15, 2023
Sponsor
Centre Hospitalier Sud Francilien
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1. Study Identification

Unique Protocol Identification Number
NCT04893135
Brief Title
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
Acronym
RANKL-GLYC
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
October 11, 2021 (Actual)
Primary Completion Date
October 11, 2022 (Actual)
Study Completion Date
October 11, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Sud Francilien

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type II Diabetes
Keywords
Diabetes's complications, neuroarthropathy Physical activity, RNKL/OPG

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
G1A
Arm Type
No Intervention
Arm Description
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
Arm Title
G1B
Arm Type
Experimental
Arm Description
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
Arm Title
G2
Arm Type
No Intervention
Arm Description
Controlled diabetes (HbA1c level <7%). This group will study the natural course of RANKL levels in balanced diabetic patients.
Intervention Type
Other
Intervention Name(s)
pratice physical activity
Intervention Description
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%
Primary Outcome Measure Information:
Title
RANKL/OPG level
Description
RANKL/OPG level
Time Frame
at 3 months
Secondary Outcome Measure Information:
Title
Sudoscan measurement
Description
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,
Time Frame
at 3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Centre Hospitalier Sud Francilien
City
Corbeil-Essonnes
ZIP/Postal Code
91100
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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