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

Aarhus University Hospital

Status: Completed

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

Treatments: Behavioral: Moderate intensity bike exercise

Study type: Interventional

Funder types: Other

Identifiers

NCT06668090

1-10-72-221-19

Details and patient eligibility

About

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.

Enrollment: 42 patients

Sex: All

Ages: 45+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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42 participants in 2 patient groups

Exercise

Experimental group

Description:

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.

Treatment:

Behavioral: Moderate intensity bike exercise

Control/no intervention

No Intervention group

Description:

12 weeks with usual activity level. No changes in diet.