How improved sensitivity to insulin affects bone health in persons with type 2 diabetes

Phase 1

• Conditions: Type 2 diabetes mellitus Diabetic bone disease; MedDRA version: 21.1 Level: PT Classification code 10067585 Term: Type 2 diabetes mellitus System Organ Class: 10027433 - Metabolism and nutrition disorders; Therapeutic area: Diseases [C] - Hormonal diseases [C19]

• Registration Number: EUCTR2019-003771-19-DK
• Lead Sponsor: Aarhus Universitetshospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-10-02
• Last Update Posted: 1 February 2020

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Not specified
• Target Recruitment: 104

Inclusion Criteria

Diagnosed type 2 diabetes mellitus
Alder = 45 years
Male gender OR female gender and postmenopausality
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 52
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 52

Exclusion Criteria

Current or previous treatment with other antidiabetics than metformin
Premature menopause (menopause before 40 years of age)
Treatment with systemic glucocorticoids within 2 years
Treatment with antiresorptive or bone anabolic drugs (ever)
Lithium treatment (ever)
Anticonvulsive treatment (ever)
Current menopausal hormone replacement therapy
eGFR < 60 ml/min
Significant cardiovascular, endocrinological, renal, hepati, rheumatological, gastrointestinal or other illness
Osteoporosis or other bone disease
D-vitamine deficiency
Recent bone fractures (6 months)
Previous fractures in both ankles (tibia) or both wrists (radius)
Active cancer within previous 5 years or other unstable medical illness
Assessed inability to participate in trial-related interventions or examinations
Allergy to relevant pharmaceuticals

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To investigate whether improved insulin sensitivity (by training and/or metformin use) in diabetics leads to increased bone turnover and bone reparation.;Secondary Objective: To investigate whether improved insulin sensitivity (by training and/or metformin use) in diabetics leads to improved bone biomechanical properties (bone structure), bone marrow turnover, and changes in fat tissue and body composition.;Primary end point(s): Bone turnover markers in blood;Timepoint(s) of evaluation of this end point: 12-13 weeks

Secondary Outcome Measures

Name	Time	Method
<br> Secondary end point(s): Bone biomechanical properties (assessed by HRpQCT-scan)<br> Bone marrow levels of bone turnover<br> Body composition<br> Fat tissue expression levels of metabolism-related genes and proteins<br> Insulin sensitivity (measured as steady-state plasma glucose by insulin suppression test)<br> ;Timepoint(s) of evaluation of this end point: 12-13 weeks