Bone Properties Following Exercise Induced Changes in Insulin Sensitivity in People With Type 2 Diabetes

NCT ID: NCT06668090

Last Updated: 2025-08-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 42 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-12-15
• Study Completion Date: 2025-06-28

Brief Summary

Diabetes mellitus type 2 is associated with low bone turnover and increased risk of bone fractures.

Bone mineral density, however, is increased and cannot explain the increased fracture risk per se. The pathophysiology is not completely understood, but the decrease in bone turnover is believed to cause an accumulation of microcracks in bone tissue leading to bone fragility. The decrease in bone turnover may arise directly from insulin resistance or indirectly through formation of advanced glycation end-products.

The main aim objective is to investigate how increases in insulin sensitivity following 12 weeks of moderate intensity bike exercise affect biochemical bone turnover markers and biomechanical bone properties in individuals with diabetes mellitus type 2.

Conditions

Diabetes Mellitus, Type 2; Insulin Resistance; Bone Diseases, Metabolic; Osteoporosis, Osteopenia; Musculoskeletal Diseases; Metabolic Disease; Glucose Metabolism Disorders

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Exercise

Moderate intensity bike exercise thrice weekly for 12 week added to the usual activity level.

Each participant receive an individual exercise program based on their maximum heart rate.

Exercise is not supervised, but compliance is monitored. It will either be performed at home or at gyms.

No changes in diet.

Group Type: EXPERIMENTAL

Moderate intensity bike exercise

Intervention Type: BEHAVIORAL

Participants will do moderate intensity bike exercise for up to one hour thrice weekly for 12 weeks.

Control/no intervention

12 weeks with usual activity level.

No changes in diet.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Moderate intensity bike exercise

Participants will do moderate intensity bike exercise for up to one hour thrice weekly for 12 weeks.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Diabetes mellitus type 2
• Age ≥ 45 years
• Male or female sex
• Women must be postmenopausal

Exclusion Criteria

• Recent substantial changes in diet (within 3 months)
• Recent substantial changes in activity level (within 3 months)
• Recent substantial weight changes (within 3 months)
• Current or previous treatment (within the last 2 years) with non-oral anti-diabetics or oral GLP-1 analogs
• HbA1c ≥ 90 mmol/mol
• HbA1c < 48 mmol/mol without anti-diabetic medication
• Premature menopause (menopause before 40 years of age)
• Current pregnancy
• Treatment with one of the following medications:

• Systemic glucocorticoids (within the last 2 years)
• Antiresorptive or bone anabolic medication (ever)
• Lithium (ever)
• Anticonvulsive medication (current)
• Menopausal replacement therapy (currently)
• Estimered glomerular filtrationsrate (eGFR) < 60 mL/minutes
• High level of physical activity, assessed by the investigators to interfere with the study results
• Substantial cardiovascular, endocrine, renal, hepatic, rheumatological, gastrointestinal or other disorders assessed by the investigator
• Electronic implants
• Osteoporosis or other bone disease
• Resent bone fracture (within 6 months)
• Previous bone fracture in either both tibial bones or both radial bones
• Parathyroid or calcium metabolism disorder
• Vitamin D deficiency (< 50 nmol/L)
• Other substantial medical disorder in unstable phase or active cancer within the last five years except spino- or basocellular carcinoma
• Lack of ability to complete the intervention
• Patients assessed uneligible by the investigator to participate in the study

• Minimum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Novo Nordic Foundation

OTHER

Sponsor Role: collaborator

Aalborg University Hospital

OTHER

Sponsor Role: collaborator

Aarhus University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Søren Gregersen

Clinical Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Steno Diabetes Center Aarhus

Aarhus N, , Denmark

Countries

Denmark

Other Identifiers

1-10-72-221-19

Identifier Type: -

Identifier Source: org_study_id