Diabetes Mellitus, Type 2NCT06668090
Bone Properties Following Exercise Induced Changes in Insulin Sensitivity in People With Type 2 Diabetes
A study testing Moderate intensity bike exercise in people with Diabetes Mellitus, Type 2 and Insulin Resistance, run by Aarhus University Hospital at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 45 years and older
- Conditions the study is for
- Diabetes Mellitus, Type 2, Insulin Resistance, Bone Diseases, Metabolic
- What is being tested?
- Moderate intensity bike exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteDenmark
- Study dates
- 15 Dec 2022to 28 Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diabetes mellitus type 2
- Age ≥ 45 years
- Male or female sex
- Women must be postmenopausal
Who cannot join
- 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
Show all 26Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Biochemical Bone Turnover Markers and Bone Mechanical 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.
- Conditions
- Diabetes Mellitus, Type 2, Insulin Resistance, Bone Diseases, Metabolic, Osteoporosis, Osteopenia, Musculoskeletal Diseases, Metabolic Disease
- Being tested
- Moderate intensity bike exercise
- Keywords
- Diabetes Mellitus, Type 2, Bone, Bioelectric impedance, Diabetic bone disease, Insulin supression test (IST), Bone turnover
- Medical subject headings
- Diabetes Mellitus, Type 2, Insulin Resistance, Bone Diseases, Metabolic, Osteoporosis, Musculoskeletal Diseases, Metabolic Diseases, Glucose Metabolism Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Moderate intensity bike exerciseBehavioural
Participants will do moderate intensity bike exercise for up to one hour thrice weekly for 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Moderate intensity bike exercise |
| Control/no intervention | No intervention | 12 weeks with usual activity level. No changes in diet. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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)
During fasting.
Measured: 12-week change. Comparison between pre-intervention and end-intervention
Fasting Homeostatic Model Assessment for Insulin Resistance by C-peptide (arbitrary unit).
Measured: 12-week change. Comparison between pre-intervention blood samples and end-intervention blood samples.
Circulating glucose (mmol/l)
Fasting
Measured: 12-week change. Comparison between pre-intervention and end-intervention
Circulating insulin (pmol/l)
Fasting
Measured: 12-week change. Comparison between pre-intervention and end-intervention
Alkaline phosphatase (total and bone type) (U/l)
Fasting
Measured: 12-week change. Comparison between pre-intervention and end-intervention
Circulating CTX (µg/l)
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
Measured: 12-week change. Comparison between pre-intervention and end-intervention
Circulating Osteocalcin (µg/l)
Measured during fasting and during stage 1 and 2 of the insulin suppression test
Measured: 12-week change. Comparison between pre-intervention and end-intervention
Circulating Osteoglycin (µg/l)
They are measured during fasting and during stage 1 and 2 of the insulin suppression test
Measured: 12-week change. Comparison between pre-intervention and end-intervention
Circulating P1NP (µg/l)
Measured during fasting and during stage 1 and 2 of the insulin suppression test
Measured: 12-week change. Comparison between pre-intervention and end-intervention
Circulating Sclerostin (µg/l)
Measured during fasting and during stage 1 and 2 of the insulin suppression test
Measured: 12-week change. Comparison between pre-intervention and end-intervention
Ionized calcium (mmol/l)
Fasting
Measured: 12-week change. Comparison between pre-intervention and end-intervention
Circulating Parathyroid hormone (pmol/l)
Measured during fasting and during stage 1 and 2 of the insulin suppression test
Measured: 12-week change. Comparison between pre-intervention and end-intervention
Vitamin D (nmol/l)
Fasting
Measured: 12-week change. Comparison between pre-intervention and end-intervention
Bone Mineral Density (t-score) in hip and spine
Dual-energy X-ray absorptiometry (DXA).
Measured: 12-week change. Comparison between pre-intervention and end-intervention
Advanced glycation end-products (AGEs) in skin
Measurement of skin autofluorescence in the forearm
Measured: 12-week change. Comparison between pre-intervention and end-intervention
Results from the HRpQCT scan including trabecular and cortical state
Measured in the tibial and radial bone on the non-dominant side
Measured: 12-week change. Comparison between pre-intervention and end-intervention
Body composition assessed with whole-body Dual-energy X-ray absorptiometry (DXA)
Measured during fasting
Measured: 12-week change. Comparison between pre-intervention and end-intervention
FIB-4 score
Using age, ALAT, ASAT and thrombocytes
Measured: 12-week change. Comparison between pre-intervention and end-intervention
Alanine aminotransferase (unit(U)/l)
Fasting
Measured: 12-week change. Comparison between pre-intervention and end-intervention
Aspartate aminotransferase (U)/l)
Fasting
Measured: 12-week change. Comparison between pre-intervention and end-intervention
Thrombocytes (10^9/l)
Fasting
Measured: 12-week change. Comparison between pre-intervention and end-intervention
Bioelectric impedance analysis (BIA)
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
Measured: 12-week change. Comparison between pre-intervention and end-intervention
Steady state glycerol and free fatty acids during stage 1 and 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.
Measured: 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.
Total cholesterol (mmol/l),
Fasting
Measured: 12-week change. Comparison between pre-intervention and end-intervention
Low density lipoprotein (LDL) (mmol/l)
Fasting
Measured: 12-week change. Comparison between pre-intervention and end-intervention
High density lipoprotein (HDL) (mmol/l)
Fastomg
Measured: 12-week change. Comparison between pre-intervention and end-intervention
Triglycerides (mmol/l)
Fasting
Measured: 12-week change. Comparison between pre-intervention and end-intervention
Blood pressure (mmHg)
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.
Measured: 12-week change. Comparison between pre-intervention and end-intervention
Body composition assessed with bioelectric impedance analysis (BIA)
Measured during fasting
Measured: 12-week change. Comparison between pre-intervention and end-intervention
Circulating adiponectin
Fasting
Measured: 12-week change. Comparison between pre-intervention and end-intervention
Leptin (n/mL)
Fasting
Measured: 12-week change. Comparison between pre-intervention and end-intervention
Alpha-hydroxybutyrate (μg/mL)
Fasting
Measured: 12-week change. Comparison between pre-intervention and end-intervention
Monocyte chemoattractant protein-1 (pg/ml)
Fasting
Measured: 12-week change. Comparison between pre-intervention and end-intervention
Interleukin 1 beta (pg/ml)
Fasting
Measured: 12-week change. Comparison between pre-intervention and end-intervention
Interleukin 6 (pg/ml)
Fasting
Measured: 12-week change. Comparison between pre-intervention and end-intervention
Estimated glomerular filtration rate (ml/min/1,73m2)
Fasting
Measured: 12-week change. Comparison between pre-intervention and end-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2024
- Study start15 Dec 2022
- Primary completion26 Jun 2025
- Study completion28 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aarhus University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- The Novo Nordic Foundation, Aalborg University Hospital
- Responsible party
- Principal investigator, Søren Gregersen, Aarhus University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06668090
- Sponsor's protocol ID
- 1-10-72-221-19
- Status last verified
- Jul 2025
- First submitted
- 30 Oct 2024
- Last updated
- 14 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biochemical Bone Turnover Markers and Bone Mechanical Properties Following Exercise Induced Changes in Insulin Sensitivity in People With Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT06668090
- Acronym / sponsor ID
- 1-10-72-221-19
- Conditions
- Diabetes Mellitus, Type 2, Insulin Resistance, Bone Diseases, Metabolic, Osteoporosis, Osteopenia, Musculoskeletal Diseases, Metabolic Disease
- Keywords
- Diabetes Mellitus, Type 2, Bone, Bioelectric impedance, Diabetic bone disease, Insulin supression test (IST), Bone turnover
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Aarhus University HospitalUniversity, hospital or other
- Collaborators
- The Novo Nordic Foundation, Aalborg University Hospital
- Study start
- 15 Dec 2022 (actual)
- Primary completion
- 26 Jun 2025 (actual)
- Study completion
- 28 Jun 2025 (actual)
- First posted
- 31 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exercise | Experimental | Behavioral: Moderate intensity bike exerciseModerate 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. |
| Control/no intervention | No intervention | –12 weeks with usual activity level. No changes in diet. |
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Diabetes mellitus type 2
- Age ≥ 45 years
- Male or female sex
- Women must be postmenopausal
Key exclusion criteria (26 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Moderate intensity bike exerciseParticipants will do moderate intensity bike exercise for up to one hour thrice weekly for 12 weeks. | Behavioural | Exercise |
Primary outcome
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.
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.
36 secondary outcomes
Hemoglobin A1c (mmol/mol)
Time frame: 12-week change. Comparison between pre-intervention and end-intervention
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.
Circulating glucose (mmol/l)
Time frame: 12-week change. Comparison between pre-intervention and end-intervention
Circulating insulin (pmol/l)
Time frame: 12-week change. Comparison between pre-intervention and end-intervention
Alkaline phosphatase (total and bone type) (U/l)
Time frame: 12-week change. Comparison between pre-intervention and end-intervention
Circulating CTX (µg/l)
Time frame: 12-week change. Comparison between pre-intervention and end-intervention
Circulating Osteocalcin (µg/l)
Time frame: 12-week change. Comparison between pre-intervention and end-intervention
Circulating Osteoglycin (µg/l)
Time frame: 12-week change. Comparison between pre-intervention and end-intervention
Circulating P1NP (µg/l)
Time frame: 12-week change. Comparison between pre-intervention and end-intervention
Circulating Sclerostin (µg/l)
Time frame: 12-week change. Comparison between pre-intervention and end-intervention
Ionized calcium (mmol/l)
Time frame: 12-week change. Comparison between pre-intervention and end-intervention
Circulating Parathyroid hormone (pmol/l)
Time frame: 12-week change. Comparison between pre-intervention and end-intervention
Vitamin D (nmol/l)
Time frame: 12-week change. Comparison between pre-intervention and end-intervention
Bone Mineral Density (t-score) in hip and spine
Time frame: 12-week change. Comparison between pre-intervention and end-intervention
Advanced glycation end-products (AGEs) in skin
Time frame: 12-week change. Comparison between pre-intervention and end-intervention
Results from the HRpQCT scan including trabecular and cortical state
Time frame: 12-week change. Comparison between pre-intervention and end-intervention
Body composition assessed with whole-body Dual-energy X-ray absorptiometry (DXA)
Time frame: 12-week change. Comparison between pre-intervention and end-intervention
FIB-4 score
Time frame: 12-week change. Comparison between pre-intervention and end-intervention
Alanine aminotransferase (unit(U)/l)
Time frame: 12-week change. Comparison between pre-intervention and end-intervention
Aspartate aminotransferase (U)/l)
Time frame: 12-week change. Comparison between pre-intervention and end-intervention
Thrombocytes (10^9/l)
Time frame: 12-week change. Comparison between pre-intervention and end-intervention
Bioelectric impedance analysis (BIA)
Time frame: 12-week change. Comparison between pre-intervention and end-intervention
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.
Total cholesterol (mmol/l),
Time frame: 12-week change. Comparison between pre-intervention and end-intervention
Low density lipoprotein (LDL) (mmol/l)
Time frame: 12-week change. Comparison between pre-intervention and end-intervention
High density lipoprotein (HDL) (mmol/l)
Time frame: 12-week change. Comparison between pre-intervention and end-intervention
Triglycerides (mmol/l)
Time frame: 12-week change. Comparison between pre-intervention and end-intervention
Blood pressure (mmHg)
Time frame: 12-week change. Comparison between pre-intervention and end-intervention
Body composition assessed with bioelectric impedance analysis (BIA)
Time frame: 12-week change. Comparison between pre-intervention and end-intervention
Circulating adiponectin
Time frame: 12-week change. Comparison between pre-intervention and end-intervention
Leptin (n/mL)
Time frame: 12-week change. Comparison between pre-intervention and end-intervention
Alpha-hydroxybutyrate (μg/mL)
Time frame: 12-week change. Comparison between pre-intervention and end-intervention
Monocyte chemoattractant protein-1 (pg/ml)
Time frame: 12-week change. Comparison between pre-intervention and end-intervention
Interleukin 1 beta (pg/ml)
Time frame: 12-week change. Comparison between pre-intervention and end-intervention
Interleukin 6 (pg/ml)
Time frame: 12-week change. Comparison between pre-intervention and end-intervention
Estimated glomerular filtration rate (ml/min/1,73m2)
Time frame: 12-week change. Comparison between pre-intervention and end-intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Moderate intensity bike exercise in people with Diabetes Mellitus, Type 2 and Insulin Resistance, run by Aarhus University Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2025.