Biochemical Bone Turnover Markers and Bone Mechanical Properties Following Exercise Induced Changes in Insulin Sensitivity in People With Type 2 Diabetes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 42
- 试验地点
- 2
- 主要终点
- Steady state plasma glucose during stage 1 of insulin suppression test (mmol/L)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 45 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diabetes mellitus type 2
- •Age ≥ 45 years
- •Male or female sex
- •Women must be postmenopausal
排除标准
- •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
结局指标
主要结局
Steady state plasma glucose during stage 1 of insulin suppression test (mmol/L)
时间窗: 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)
时间窗: 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.
次要结局
- Circulating P1NP (µg/l)(12-week change. Comparison between pre-intervention and end-intervention)
- Circulating Sclerostin (µg/l)(12-week change. Comparison between pre-intervention and end-intervention)
- Ionized calcium (mmol/l)(12-week change. Comparison between pre-intervention and end-intervention)
- 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)
- Circulating CTX (µg/l)(12-week change. Comparison between pre-intervention and end-intervention)
- Circulating Osteocalcin (µg/l)(12-week change. Comparison between pre-intervention and end-intervention)
- Circulating Osteoglycin (µg/l)(12-week change. Comparison between pre-intervention and end-intervention)
- Vitamin D (nmol/l)(12-week change. Comparison between pre-intervention and end-intervention)
- Bone Mineral Density (t-score) in hip and spine(12-week change. Comparison between pre-intervention and end-intervention)
- Advanced glycation end-products (AGEs) in skin(12-week change. Comparison between pre-intervention and end-intervention)
- Results from the HRpQCT scan including trabecular and cortical state(12-week change. Comparison between pre-intervention and end-intervention)
- Body composition assessed with whole-body Dual-energy X-ray absorptiometry (DXA)(12-week change. Comparison between pre-intervention and end-intervention)
- FIB-4 score(12-week change. Comparison between pre-intervention and end-intervention)
- Alanine aminotransferase (unit(U)/l)(12-week change. Comparison between pre-intervention and end-intervention)
- Triglycerides (mmol/l)(12-week change. Comparison between pre-intervention and end-intervention)
- Blood pressure (mmHg)(12-week change. Comparison between pre-intervention and end-intervention)
- Body composition assessed with bioelectric impedance analysis (BIA)(12-week change. Comparison between pre-intervention and end-intervention)
- Circulating adiponectin(12-week change. Comparison between pre-intervention and end-intervention)
- Leptin (n/mL)(12-week change. Comparison between pre-intervention and end-intervention)
- Alpha-hydroxybutyrate (μg/mL)(12-week change. Comparison between pre-intervention and end-intervention)
- Monocyte chemoattractant protein-1 (pg/ml)(12-week change. Comparison between pre-intervention and end-intervention)
- Interleukin 1 beta (pg/ml)(12-week change. Comparison between pre-intervention and end-intervention)
- Interleukin 6 (pg/ml)(12-week change. Comparison between pre-intervention and end-intervention)
- Estimated glomerular filtration rate (ml/min/1,73m2)(12-week change. Comparison between pre-intervention and end-intervention)
- Circulating Parathyroid hormone (pmol/l)(12-week change. Comparison between pre-intervention and end-intervention)
- Aspartate aminotransferase (U)/l)(12-week change. Comparison between pre-intervention and end-intervention)
- Thrombocytes (10^9/l)(12-week change. Comparison between pre-intervention and end-intervention)
- Bioelectric impedance analysis (BIA)(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)(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),(12-week change. Comparison between pre-intervention and end-intervention)
- Low density lipoprotein (LDL) (mmol/l)(12-week change. Comparison between pre-intervention and end-intervention)
- High density lipoprotein (HDL) (mmol/l)(12-week change. Comparison between pre-intervention and end-intervention)
研究者
Søren Gregersen
Clinical Associate Professor
Aarhus University Hospital