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| Name | Class |
|---|---|
| The Novo Nordic Foundation | OTHER |
| Aalborg University Hospital | OTHER |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Control/no intervention | No Intervention | 12 weeks with usual activity level. No changes in diet. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Moderate intensity bike exercise | Behavioral | Participants will do moderate intensity bike exercise for up to one hour thrice weekly for 12 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Hemoglobin A1c (mmol/mol) | During fasting. | 12-week change. Comparison between pre-intervention and end-intervention |
| Fasting Homeostatic Model Assessment for Insulin Resistance by C-peptide (arbitrary unit). |
| Measure | Description | Time Frame |
|---|---|---|
| Thyroid-stimulating hormone (international unit (IU)/l) | Fasting | 12-week change. Comparison between pre-intervention and end-intervention |
| High sensitivity C reactive protein (mg/l) | Fasting |
Inclusion Criteria:
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:
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
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Steno Diabetes Center Aarhus | Aarhus N | 8200 | Denmark |
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| 12-week change. Comparison between pre-intervention blood samples and end-intervention blood samples. |
| Circulating glucose (mmol/l) | Fasting | 12-week change. Comparison between pre-intervention and end-intervention |
| Circulating insulin (pmol/l) | Fasting | 12-week change. Comparison between pre-intervention and end-intervention |
| Alkaline phosphatase (total and bone type) (U/l) | Fasting | 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 | 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 | 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 | 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 | 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 | 12-week change. Comparison between pre-intervention and end-intervention |
| Ionized calcium (mmol/l) | Fasting | 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 | 12-week change. Comparison between pre-intervention and end-intervention |
| Vitamin D (nmol/l) | Fasting | 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). | 12-week change. Comparison between pre-intervention and end-intervention |
| Advanced glycation end-products (AGEs) in skin | Measurement of skin autofluorescence in the forearm | 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 | 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 | 12-week change. Comparison between pre-intervention and end-intervention |
| FIB-4 score | Using age, ALAT, ASAT and thrombocytes | 12-week change. Comparison between pre-intervention and end-intervention |
| Alanine aminotransferase (unit(U)/l) | Fasting | 12-week change. Comparison between pre-intervention and end-intervention |
| Aspartate aminotransferase (U)/l) | Fasting | 12-week change. Comparison between pre-intervention and end-intervention |
| Thrombocytes (10^9/l) | Fasting | 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 | 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. | 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 | 12-week change. Comparison between pre-intervention and end-intervention |
| Low density lipoprotein (LDL) (mmol/l) | Fasting | 12-week change. Comparison between pre-intervention and end-intervention |
| High density lipoprotein (HDL) (mmol/l) | Fastomg | 12-week change. Comparison between pre-intervention and end-intervention |
| Triglycerides (mmol/l) | Fasting | 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. | 12-week change. Comparison between pre-intervention and end-intervention |
| Body composition assessed with bioelectric impedance analysis (BIA) | Measured during fasting | 12-week change. Comparison between pre-intervention and end-intervention |
| Circulating adiponectin | Fasting | 12-week change. Comparison between pre-intervention and end-intervention |
| Leptin (n/mL) | Fasting | 12-week change. Comparison between pre-intervention and end-intervention |
| Alpha-hydroxybutyrate (μg/mL) | Fasting | 12-week change. Comparison between pre-intervention and end-intervention |
| Monocyte chemoattractant protein-1 (pg/ml) | Fasting | 12-week change. Comparison between pre-intervention and end-intervention |
| Interleukin 1 beta (pg/ml) | Fasting | 12-week change. Comparison between pre-intervention and end-intervention |
| Interleukin 6 (pg/ml) | Fasting | 12-week change. Comparison between pre-intervention and end-intervention |
| Estimated glomerular filtration rate (ml/min/1,73m2) | Fasting | 12-week change. Comparison between pre-intervention and end-intervention |
| 12-week change. Comparison between pre-intervention and end-intervention |
| Thyroid stimulating hormone (pmol/l) | Fasting | 12-week change. Comparison between pre-intervention and end-intervention |
| Creatinine (μmol/l) | Fasting | 12-week change. Comparison between pre-intervention and end-intervention |
| Activity tracking | Measured with accelerometer on thigh of non-dominant leg | 12-week change. Comparison between pre-intervention and end-intervention |
| Activity level - questionnaire | 12-week change. Comparison between pre-intervention and end-intervention |
| Diet diary (3 days) | 12-week change. Comparison between pre-intervention and end-intervention |
| Urine albumin-to-creatinine ratio (mg/g) | Fasting | 12-week change. Comparison between pre-intervention and end-intervention |
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D007333 | Insulin Resistance |
| D001851 | Bone Diseases, Metabolic |
| D010024 | Osteoporosis |
| D009140 | Musculoskeletal Diseases |
| D008659 | Metabolic Diseases |
| D044882 | Glucose Metabolism Disorders |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D006946 | Hyperinsulinism |
| D001847 | Bone Diseases |
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