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

NCT06668090 | Completed

• 1 other identifier: 1-10-72-221-19
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Keywords

Diabetes Mellitus, Type 2; Bone; Bioelectric impedance; Diabetic bone disease; Insulin supression test (IST); Bone turnover

Outcome Measures

Primary Outcomes (2)

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

  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.

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

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

  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.

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

Secondary Outcomes (36)

• Hemoglobin A1c (mmol/mol)

  12-week change. Comparison between pre-intervention and end-intervention

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

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

• Circulating glucose (mmol/l)

  12-week change. Comparison between pre-intervention and end-intervention

• Circulating insulin (pmol/l)

  12-week change. Comparison between pre-intervention and end-intervention

• Alkaline phosphatase (total and bone type) (U/l)

  12-week change. Comparison between pre-intervention and end-intervention

Other Outcomes (8)

• Thyroid-stimulating hormone (international unit (IU)/l)

  12-week change. Comparison between pre-intervention and end-intervention

• High sensitivity C reactive protein (mg/l)

  12-week change. Comparison between pre-intervention and end-intervention

• Thyroid stimulating hormone (pmol/l)

  12-week change. Comparison between pre-intervention and end-intervention

Study Arms (2)

Exercise

EXPERIMENTAL

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.

Behavioral: Moderate intensity bike exercise

Control/no intervention

NO INTERVENTION

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

Interventions

Moderate intensity bike exercise BEHAVIORAL

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

Exercise

Eligibility Criteria

• Age: 45 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diabetes mellitus type 2
• Age ≥ 45 years
• Male or female sex
• Women must be postmenopausal

You may not qualify if:

• 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

Sponsors & Collaborators

• Aarhus University Hospital: lead
• The Novo Nordic Foundation: collaborator
• Aalborg University Hospital: collaborator

Study Sites (1)

Steno Diabetes Center Aarhus

Aarhus N, 8200, Denmark

Location

MeSH Terms

Conditions

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

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Nutritional and Metabolic Diseases; Endocrine System Diseases; Hyperinsulinism; Bone Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Associate Professor

Study Record Dates

• First Submitted: October 30, 2024
• First Posted: October 31, 2024
• Study Start: December 15, 2022
• Primary Completion: June 26, 2025
• Study Completion: June 28, 2025
• Last Updated: August 14, 2025

Record last verified: 2025-07

Locations

DK (1)