Bone Properties Following Exercise Induced Changes in Insulin Sensitivity in People With Type 2 D… (NCT06668090) | Clinical Trial Compass
CompletedNot Applicable
Bone Properties Following Exercise Induced Changes in Insulin Sensitivity in People With Type 2 Diabetes
Denmark42 participantsStarted 2022-12-15
Plain-language 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.
Who can participate
Age range
45 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 yea…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Steady state plasma glucose during stage 1 of insulin suppression test (mmol/L)
Timeframe: 100, 110 and 120 minutes after test-start. 12-week change. Comparison between pre-intervention and end-intervention steady state plasma glucose.
2
Steady state plasma glucose during stage 2 of insulin suppression test (mmol/L)
Timeframe: 220, 230 and 240 minutes after test-start. 12-week change. Comparison between pre-intervention and end-intervention steady state plasma glucose