Comparing the Clinical Characteristics of Male LADA, T1DM and T2DM Patients

Study Overview
=================
Brief Summary
-----------------
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.

Detailed Description
-----------------
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.

Official Title
-----------------
Comparing the Clinical Characteristics of Male Patients With Latent Autoimmune Diabetes ,Classic Type 2 Diabetes and Classic Type 2 Diabetes

Conditions
-----------------
Diabetes

Intervention / Treatment
-----------------
* Other: No interventions


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 30   80 years old male; Meet the American Diabetes Association (ADA) definition and standards for diabetes Exclusion Criteria: 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.

Ages Eligible for Study
-----------------
Minimum Age: 30 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| LADA group<br>The patient was diagnosed with late-onset autoimmune diabetes (LADA). | Other: No interventions<br>* This clinical study is a retrospective study, and no interventions have been implemented for patients.<br>|
| T2DM group<br>The patient was diagnosed with type 2 diabetes (T2DM). | Other: No interventions<br>* This clinical study is a retrospective study, and no interventions have been implemented for patients.<br>|
| T1DM group<br>The patient was diagnosed with type 1 diabetes (T1DM). | Other: No interventions<br>* This clinical study is a retrospective study, and no interventions have been implemented for patients.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Testosterone | total testosterone (nmol/L), testosterone (nmol/L) and SHBG (nmol/L). Hypogonadism was defined as total testosterone levels less than 3.0 ng/ml | 2016-2021 | 
| Bone mineral density | Bone mineral density was measured at the lumbar spine, femoral neck, and right hip by dual-energy x-ray absorptiometry (DXA) | 2016-2021 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HbA1c | Glycosylated hemoglobin A1c | 2016-2021 | 
| FBG | patients with fasting blood glucose 6.1mmol/l or more | 2016-2021 | 
| PBG | patients with 2 hour blood glucose 7.8mmol/l or more | 2016-2021 | 
| FINS | metabolic profile fasting insulin (IU/L) | 2016-2021 | 
| PINS | patients with 2 hour blood insulin | 2016-2021 | 
| TC | metabolic profile Total cholesterol (mmol/L) | 2016-2021 | 
| TG | metabolic profile Triglycerides (mmol/L) | 2016-2021 | 
| HDL-c | metabolic profile high-density lipoprotein cholesterol (mmol/L) | 2016-2021 | 
| LDL-c | metabolic profile Low-density lipoprotein cholesterol (mmol/L) | 2016-2021 | 
| FSH | follicle-stimulating hormone | 2016-2021 | 
| LH | luteinizing hormone | 2016-2021 |