Comparing the Clinical Characteristics of Male Patients With Latent Autoimmune Diabetes ,Classic Type 2 Diabetes and Classic Type 2 Diabetes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 632
- 试验地点
- 1
- 主要终点
- Bone mineral density
研究概览
简要总结
Diabetes is a common chronic disease in most parts of the world. Diabetes-related complications are harmful to the human body. Different types of diabetes have different levels of harm to the human body. There are also fewer studies on the relationship between specific types of diabetes and clinical diseases such as osteoporosis and Hypogonadism. Therefore, clarifying the differences in the clinical characteristics of adult men with late-onset autoimmune diabetes (LADA) ,Classical type 1 diabetes (T1DM) and type 2 diabetes (T2DM) will help to further understand the effects of diabetes on bone metabolism and sex hormones.
详细描述
Diabetes is a common chronic disease in most parts of the world. Diabetes-related complications are harmful to the human body. There are also fewer studies on the relationship between specific types of diabetes and clinical diseases such as osteoporosis and Hypogonadism. This study aimed to compare the prevalence of hypogonadism and osteoporosis among male patients with latent autoimmune diabetes (LADA), type 1 diabetes (T1DM) and type 2 diabetes (T2DM) and investigate the protective factors for hypogonadism and osteoporosis in these patients. This cross-sectional study evaluated male patients with LADA, T1DM, and T2DM who visited the endocrinology department of Shanghai Tenth People's Hospital for diabetes management. Sex hormones, lipid profiles, sex hormone-binding globulin (SHBG), glycosylated hemoglobin A1c, beta-cell function, uric acid, and osteocalcin were determined in serum samples. Therefor，clarifying the differences in the clinical characteristics of adult men with LADA, T1DM and T2DM will help to further understand the effects of diabetes on bone metabolism and sex hormones.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 30 Years 至 80 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •30 ~ 80 years old male;
- •Meet the American Diabetes Association (ADA) definition and standards for diabetes
排除标准
- •having diseases that affect bone and calcium metabolism, such as hyperthyroidism, hyperparathyroidism, hypogonadism, cushing syndrome, rheumatoid arthritis, cirrhosis, or malignant tumor;
- •the use in the past 6 months of drugs that interfere with bone and calcium metabolism, such as sex steroids, vitamin D metabolites, calcitonin, bisphosphonates, and thyroid hormone;
- •moderate or severe liver and renal dysfunction, including serum alanine aminotransferase of 120 IU/L, aspartate aminotransferase of 80 IU/L, and serum creatinine of 120 μmol/L.
- •4）a history of congenital/hypogonadotropic hypogonadism or hyperthyroidism, or those who received testosterone replacement therapy in the past 6 months were excluded.
结局指标
主要结局
Bone mineral density
时间窗: 2016-2021
Bone mineral density was measured at the lumbar spine, femoral neck, and right hip by dual-energy x-ray absorptiometry (DXA)
Testosterone
时间窗: 2016-2021
total testosterone (nmol/L), testosterone (nmol/L) and SHBG (nmol/L). Hypogonadism was defined as total testosterone levels less than 3.0 ng/ml
次要结局
- PBG(2016-2021)
- FINS(2016-2021)
- TG(2016-2021)
- PINS(2016-2021)
- TC(2016-2021)
- HbA1c(2016-2021)
- HDL-c(2016-2021)
- LDL-c(2016-2021)
- LH(2016-2021)
- FBG(2016-2021)
- FSH(2016-2021)
研究者
Zhang Manna
Director, Principal Investigator, Clinical Professor
Shanghai 10th People's Hospital