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NCT Number: NCT06668090

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

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.

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Key information

Conditions

Diabetes Mellitus, Type 2 Bone Diseases Bone Diseases, Metabolic Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Metabolic Disease Metabolic Diseases Musculoskeletal Diseases Nutritional and Metabolic Diseases Osteoporosis Osteoporosis, Osteopenia

Age range

45 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Steno Diabetes Center Aarhus

Aarhus N, 8200, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Moderate intensity bike exercise

Behavioral

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

Primary outcomes

  1. Steady state plasma glucose during stage 1 of insulin suppression test (mmol/L)

    Time frame: 100, 110 and 120 minutes after test-start. 12-week change. Comparison between pre-intervention and end-intervention steady state plasma glucose.

    Subjects are administered a 25 μg octreotide bolus at time-point 0 minutes and subsequently infused with 0.27 μg octreotide / m2 • minute, 6 milliunits (mU) insulin / m2 • minute, and 50 mg glucose / m2 • min.

  2. Steady state plasma glucose during stage 2 of insulin suppression test (mmol/L)

    Time frame: 220, 230 and 240 minutes after test-start. 12-week change. Comparison between pre-intervention and end-intervention steady state plasma glucose

    Subjects are administered a 25 μg octreotide bolus at time-point 0 minutes and subsequently infused with 0.27 μg octreotide / m2 • minute, 6 (mU) insulin / m2 • minute, and 50 mg glucose / m2 • minute. At time-point 120 minutes, infusion speeds are increased to to 32 mU insulin / m2 • minute and 267 mg glucose / m2 • minute.

Secondary outcomes

  1. Hemoglobin A1c (mmol/mol)

    Time frame: 12-week change. Comparison between pre-intervention and end-intervention

    During fasting.

  2. Fasting Homeostatic Model Assessment for Insulin Resistance by C-peptide (arbitrary unit).

    Time frame: 12-week change. Comparison between pre-intervention blood samples and end-intervention blood samples.

  3. Circulating glucose (mmol/l)

    Time frame: 12-week change. Comparison between pre-intervention and end-intervention

    Fasting

  4. Circulating insulin (pmol/l)

    Time frame: 12-week change. Comparison between pre-intervention and end-intervention

    Fasting

  5. Alkaline phosphatase (total and bone type) (U/l)

    Time frame: 12-week change. Comparison between pre-intervention and end-intervention

    Fasting

  6. Circulating CTX (µg/l)

    Time frame: 12-week change. Comparison between pre-intervention and end-intervention

    Measured during fasting and during stage 1 and 2 of the insulin suppression test They are measured during fasting and during stage 1 and 2 of the insulin suppression test

  7. Circulating Osteocalcin (µg/l)

    Time frame: 12-week change. Comparison between pre-intervention and end-intervention

    Measured during fasting and during stage 1 and 2 of the insulin suppression test

  8. Circulating Osteoglycin (µg/l)

    Time frame: 12-week change. Comparison between pre-intervention and end-intervention

    They are measured during fasting and during stage 1 and 2 of the insulin suppression test

  9. Circulating P1NP (µg/l)

    Time frame: 12-week change. Comparison between pre-intervention and end-intervention

    Measured during fasting and during stage 1 and 2 of the insulin suppression test

  10. Circulating Sclerostin (µg/l)

    Time frame: 12-week change. Comparison between pre-intervention and end-intervention

    Measured during fasting and during stage 1 and 2 of the insulin suppression test

  11. Ionized calcium (mmol/l)

    Time frame: 12-week change. Comparison between pre-intervention and end-intervention

    Fasting

  12. Circulating Parathyroid hormone (pmol/l)

    Time frame: 12-week change. Comparison between pre-intervention and end-intervention

    Measured during fasting and during stage 1 and 2 of the insulin suppression test

  13. Vitamin D (nmol/l)

    Time frame: 12-week change. Comparison between pre-intervention and end-intervention

    Fasting

  14. Bone Mineral Density (t-score) in hip and spine

    Time frame: 12-week change. Comparison between pre-intervention and end-intervention

    Dual-energy X-ray absorptiometry (DXA).

  15. Advanced glycation end-products (AGEs) in skin

    Time frame: 12-week change. Comparison between pre-intervention and end-intervention

    Measurement of skin autofluorescence in the forearm

  16. Results from the HRpQCT scan including trabecular and cortical state

    Time frame: 12-week change. Comparison between pre-intervention and end-intervention

    Measured in the tibial and radial bone on the non-dominant side

  17. Body composition assessed with whole-body Dual-energy X-ray absorptiometry (DXA)

    Time frame: 12-week change. Comparison between pre-intervention and end-intervention

    Measured during fasting

  18. FIB-4 score

    Time frame: 12-week change. Comparison between pre-intervention and end-intervention

    Using age, ALAT, ASAT and thrombocytes

  19. Alanine aminotransferase (unit(U)/l)

    Time frame: 12-week change. Comparison between pre-intervention and end-intervention

    Fasting

  20. Aspartate aminotransferase (U)/l)

    Time frame: 12-week change. Comparison between pre-intervention and end-intervention

    Fasting

  21. Thrombocytes (10^9/l)

    Time frame: 12-week change. Comparison between pre-intervention and end-intervention

    Fasting

  22. Bioelectric impedance analysis (BIA)

    Time frame: 12-week change. Comparison between pre-intervention and end-intervention

    Following measurements will be evaluated: Phase angle, membrane capacitance, impedance, capacitive resistance, resistance.

    Measured during fasting and stage 1 and 2 of insulin suppression test

  23. Steady state glycerol and free fatty acids during stage 1 and 2 of insulin suppression test (mmol/L)

    Time frame: 100, 110, 120, 220, 230 and 240 minutes after test-start. 12-week change. Comparison between pre-intervention and end-intervention steady state plasma glucose.

    Subjects are administered a 25 μg octreotide bolus at time-point 0 minutes and subsequently infused with 0.27 μg octreotide / m2 • minute, 6 (mU) insulin / m2 • minute, and 50 mg glucose / m2 • minute. At time-point 120 minutes, infusion speeds are increased to to 32 mU insulin / m2 • minute and 267 mg glucose / m2 • minute.

  24. Total cholesterol (mmol/l),

    Time frame: 12-week change. Comparison between pre-intervention and end-intervention

    Fasting

  25. Low density lipoprotein (LDL) (mmol/l)

    Time frame: 12-week change. Comparison between pre-intervention and end-intervention

    Fasting

  26. High density lipoprotein (HDL) (mmol/l)

    Time frame: 12-week change. Comparison between pre-intervention and end-intervention

    Fastomg

  27. Triglycerides (mmol/l)

    Time frame: 12-week change. Comparison between pre-intervention and end-intervention

    Fasting

  28. Blood pressure (mmHg)

    Time frame: 12-week change. Comparison between pre-intervention and end-intervention

    Average daytime and night-time ambulatory blood pressure. 24-hour ambulatory blood pressure measurement, measured every 20 minutes during daytime and every 30 minutes during nighttime.

  29. Body composition assessed with bioelectric impedance analysis (BIA)

    Time frame: 12-week change. Comparison between pre-intervention and end-intervention

    Measured during fasting

  30. Circulating adiponectin

    Time frame: 12-week change. Comparison between pre-intervention and end-intervention

    Fasting

  31. Leptin (n/mL)

    Time frame: 12-week change. Comparison between pre-intervention and end-intervention

    Fasting

  32. Alpha-hydroxybutyrate (μg/mL)

    Time frame: 12-week change. Comparison between pre-intervention and end-intervention

    Fasting

  33. Monocyte chemoattractant protein-1 (pg/ml)

    Time frame: 12-week change. Comparison between pre-intervention and end-intervention

    Fasting

  34. Interleukin 1 beta (pg/ml)

    Time frame: 12-week change. Comparison between pre-intervention and end-intervention

    Fasting

  35. Interleukin 6 (pg/ml)

    Time frame: 12-week change. Comparison between pre-intervention and end-intervention

    Fasting

  36. Estimated glomerular filtration rate (ml/min/1,73m2)

    Time frame: 12-week change. Comparison between pre-intervention and end-intervention

    Fasting

Other outcomes

  1. Thyroid-stimulating hormone (international unit (IU)/l)

    Time frame: 12-week change. Comparison between pre-intervention and end-intervention

    Fasting

  2. High sensitivity C reactive protein (mg/l)

    Time frame: 12-week change. Comparison between pre-intervention and end-intervention

    Fasting

  3. Thyroid stimulating hormone (pmol/l)

    Time frame: 12-week change. Comparison between pre-intervention and end-intervention

    Fasting

  4. Creatinine (μmol/l)

    Time frame: 12-week change. Comparison between pre-intervention and end-intervention

    Fasting

  5. Activity tracking

    Time frame: 12-week change. Comparison between pre-intervention and end-intervention

    Measured with accelerometer on thigh of non-dominant leg

  6. Activity level - questionnaire

    Time frame: 12-week change. Comparison between pre-intervention and end-intervention

  7. Diet diary (3 days)

    Time frame: 12-week change. Comparison between pre-intervention and end-intervention

  8. Urine albumin-to-creatinine ratio (mg/g)

    Time frame: 12-week change. Comparison between pre-intervention and end-intervention

    Fasting

Sponsors and collaborators

Lead sponsor

Aarhus University Hospital

Other

Collaborators

  • Aalborg University Hospital
  • The Novo Nordic Foundation

Registry information

Official study title

Biochemical Bone Turnover Markers and Bone Mechanical Properties Following Exercise Induced Changes in Insulin Sensitivity in People With Type 2 Diabetes

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Oct 31, 2024
Registry last updated
Aug 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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