NCT06668090Completed
Bone Properties Following Exercise Induced Changes in Insulin Sensitivity 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
Source: ClinicalTrials.gov · Last updated 14 Aug 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 42 (actual)
- First submitted
- 30 Oct 2024
- Start date
- 15 Dec 2022
- Primary completion date
- 26 Jun 2025
- Lead sponsor
- Aarhus University Hospital
- Diseases
- Type 2 diabetes, Osteoporosis
- NCT number
- NCT06668090
What you commit to
- Study type: Interventional
- Participants enrolled: 42
- From 15 Dec 2022 to the primary completion date, 26 Jun 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Current or previous treatment (within the last 2 years) with non-oral anti-diabetics or oral GLP-1 analogs
- 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)
- Electronic implants
- Previous bone fracture in either both tibial bones or both radial bones
Other illness
- Substantial cardiovascular, endocrine, renal, hepatic, rheumatological, gastrointestinal or other disorders assessed by the investigator
- Osteoporosis or other bone disease
- Other substantial medical disorder in unstable phase or active cancer within the last five years except spino- or basocellular carcinoma
Lab values
- HbA1c ≥ 90 mmol/mol
- HbA1c \< 48 mmol/mol without anti-diabetic medication
- Estimered glomerular filtrationsrate (eGFR) \< 60 mL/minutes
- Parathyroid or calcium metabolism disorder
Age
- Premature menopause (menopause before 40 years of age)
Other
- 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 pregnancy
- High level of physical activity, assessed by the investigators to interfere with the study results
- Resent bone fracture (within 6 months)
- Vitamin D deficiency (\< 50 nmol/L)
- Lack of ability to complete the intervention
- Patients assessed uneligible by the investigator to participate in the study
Who the study is looking for
- Diabetes mellitus type 2
- Age ≥ 45 years
- Male or female sex
- Women must be postmenopausal
Age in the registry: 45 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Steno Diabetes Center Aarhus Coordinator of this site? Confirm its status | Aarhus N | Denmark | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.