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

The effect of improved insulin sensitivity on bone turnover markers and bone biomechanical properties in persons with type 2 diabetes mellitus - METCERCISE

Status

Not yet recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2019-003771-19-DK

Enrollment

104

Registered

2019-10-02

Start date

2019-11-19

Completion date

Unknown

Last updated

2020-02-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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

Interventions

Trade Name: Mitforgen (Metformin) Pharmaceutical Form: Tablet INN or Proposed INN: METFORMIN HYDROCHLORIDE CAS Number: 1115-70-4 Concent

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
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	—

Measure

Time frame

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

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

Countries

Denmark

Contacts

Public ContactSteno Diabetes Center Aarhus

Aarhus Universitetshospital

zheer@clin.au.dk

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026