Markers of Bone Turnover and Advanced Glycation End Products Measured in the Circulation, Bone Marrow, and Bone Tissue in Individuals With and Without Type 2 Diabetes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- Plasma concentration of Osteocalcin
研究概览
简要总结
Type 2 diabetes (T2D) is related to an increased risk of major fractures which does written in English. The summary is used not only increase society health care costs, but also increase the morbidity and in the recruitment of peer reviewers.: mortality for patients with T2D. Traditional fracture predictors underestimate the risk in T2D. Thus, the bone affection is not caused by decreased bone mineral density but rather by impaired bone quality leading to fragile bone. In diabetes, circulating bone turnover markers are suppressed and advanced glycation endproducts may accumulate in the tissue. The study aims at exploring whether bone turnover in T2D is compromised in the circulation, bone marrow, and bone tissue and whether advanced glycation endproducts accumulate in these tissues. Furthermore, the investigators will assess whether bone turnover markers predict fractures in a cohort of individuals with diabetes. The project will contribute to the knowledge on bone disease in T2D and will ultimately benefit the patients by improving future fracture prevention strategies.
详细描述
3.1 Methods Study 1 is a cross-sectional study in which 26 individuals with T2D and 26 age matched individuals without T2D are examined. The investigators aim to investigate whether a) bone turnover markers are lower in individuals with type 2 diabetes (T2D) compared to persons without T2D based on circulating bone turnover markers, bone turnover markers in the bone marrow and bone turnover measured in bone tissue biopsies b) the levels of advanced glycation end-products (AGEs) in the circulation, bone marrow, bone tissue, and skin in individuals with and without T2D. The investigators hypothesize that the levels of AGEs is lower in all three tissue compartments in individuals with T2D compared to persons without T2D.
The individuals are included and recruited from outpatient clinics, general practitioners, letters based on information from national registries and via media advertisements.
Inclusion criteria for individuals with T2D; physician diagnosed T2D, diabetes duration ≥5 years, HbA1c ≥ 59 mmol/mol through the last 2 years, male gender, age > 40 years, and BMI < 35 kg/m2. Inclusion criteria for individuals without T2D; no diagnosis of T2D, male gender, age > 40 years, and BMI < 35 kg/m2. Exclusion criteria for all participants; trombocyte count < 100, treatment with anticoagulants except acetylic acids, renal impairment (eGFR <50 ml/min), bone metabolic disease, vitamin D insufficiency, treatment with antiosteoporotic agents or systemic glucocorticoids, and tetracycline allergy.
3.11 Methods Fasting morning blood samples will be collected. The participants will undergo a whole body dual energy x-ray absorptiometry (DXA) to investigate body composition (lean and fat mass) and a Jamshidi bone marrow biopsy in which two pieces of bone tissue is collected for measurement of bone turnover and AGES.
3.12. Bone tissue biopsy Before the bone tissue sampling, the bone tissue will be labelled twice by administration of tetracycline. Tetracykline is incorporated in newly formed bone as bands that are visible in a microscope. A histomorphometric analysis is conducted on the bone tissue sample to investigate the indices of bone turnover.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Inclusion criteria for individuals with T2D;
- •physician diagnosed T2D,
- •diabetes duration ≥5 years,
- •HbA1c ≥ 48 mmol/mol through the last 2 years
- •male gender,
- •age > 40 years
- •BMI < 35 kg/m2
- •Inclusion criteria for individuals without T2D;
- •no diagnosis of T2D
- •male gender,
- •age > 40 years
- •BMI < 35 kg/m2
排除标准
- •trombocyte count < 100
- •treatment with anticoagulants except acetylic acids,
- •renal impairment (eGFR <50 ml/min),
- •bone metabolic disease
- •vitamin D insufficiency
- •treatment with antiosteoporotic agents
- •Treatment with systemic glucocorticoids
- •Tetracycline allergy.
结局指标
主要结局
Plasma concentration of Osteocalcin
时间窗: 2 years
Circulating bone turnover marker
次要结局
- serum concentration of penstosidine(2 years)
- Strenght measure of bone(2 years)
- Plasma concentration of CTX(2 years)
- Plasma concentration of P1NP(2 years)
- Bone marrow serum concentration of CTX(2 years)
- bone marrow serum concentration of pentosidine(2 years)
- Advanced glycation endproductsproducts in bone(2 years)
- trabecular separation distance(2 years)
- Plasma concentration of Sclerostin(2 years)
- Bone marrow serum concentration of Sclerostin(2 years)
- Bone marrow serum concentration of P1NP(2 years)
- Bone marrow serum concentration of Osteocalcin(2 years)
- Bone formation rate in bone tissue(2 years)