Effects of exercise on bone health in people with type 2 diabetes
Biochemical Bone Turnover Markers and Bone Mechanical Properties Following Exercise Induced Changes in Insulin Sensitivity in People with Type 2 Diabetes
This study tests if moderate bike exercise for 12 weeks can improve bone health in people with type 2 diabetes by looking at how it affects insulin sensitivity and bone strength.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 45 Years and up |
| Sex | All |
| Sponsor | Aarhus University Hospital Academic / other |
| Locations | 1 site (Aarhus N) |
| Trial ID | NCT06668090 on ClinicalTrials.gov |
What this trial studies
This study investigates how moderate intensity bike exercise over 12 weeks can improve insulin sensitivity and its subsequent effects on bone turnover markers and biomechanical properties in individuals with type 2 diabetes. The research aims to understand the relationship between insulin resistance and bone fragility, as individuals with diabetes often experience low bone turnover despite increased bone mineral density. By measuring changes in bone health following exercise, the study seeks to provide insights into potential interventions for reducing fracture risk in this population.
Who should consider this trial
Good fit: Ideal candidates for this study are individuals aged 45 and older with type 2 diabetes, including both men and postmenopausal women.
Not a fit: Patients with recent significant changes in diet, activity level, or weight, as well as those on certain medications or with specific health conditions, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved strategies for enhancing bone health and reducing fracture risk in patients with type 2 diabetes.
How similar studies have performed: While the specific approach of this study may be novel, previous research has indicated that exercise can positively influence bone health in various populations, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Aarhus N
- Steno Diabetes Center Aarhus — Aarhus N, Denmark (Recruiting)
Study contacts
- Study coordinator: Søren D Isidor, MD, PhD student
- Email: auh.metcercise@rm.dk
- Phone: +45 61200257
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.