Clinical trial NCT04618354: Comparing the Clinical Characteristics of Male LADA, T1DM and T2DM Patients
Official title: Comparing the Clinical Characteristics of Male Patients With Latent Autoimmune Diabetes ,Classic Type 2 Diabetes and Classic Type 2 Diabetes
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes
Lead sponsor: Shanghai 10th People's Hospital
Sponsor class: OTHER
First posted: 2020-11-05
Enrollment: 632
Sex: MALE
Minimum age (years): 30
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 600 diabetes Patients from Shanghai Tenth People's Hospital were enrolled in this study.

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.

Eligibility criteria: Inclusion Criteria:

1. 30 \~ 80 years old male;
2. Meet the American Diabetes Association (ADA) definition and standards for diabetes

Exclusion Criteria:

1. having diseases that affect bone and calcium metabolism, such as hyperthyroidism, hyperparathyroidism, hypogonadism, cushing syndrome, rheumatoid arthritis, cirrhosis, or malignant tumor;
2. 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;
3. 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.

Primary outcomes:
measure: Testosterone
timeFrame: 2016-2021
measure: Bone mineral density
timeFrame: 2016-2021
Secondary outcomes:
measure: HbA1c
timeFrame: 2016-2021
measure: FBG
timeFrame: 2016-2021
measure: PBG
timeFrame: 2016-2021
measure: FINS
timeFrame: 2016-2021
measure: PINS
timeFrame: 2016-2021
measure: TC
timeFrame: 2016-2021
measure: TG
timeFrame: 2016-2021
measure: HDL-c
timeFrame: 2016-2021
measure: LDL-c
timeFrame: 2016-2021
measure: FSH
timeFrame: 2016-2021
measure: LH
timeFrame: 2016-2021
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Department of Endocrinology, Shanghai Tenth People's Hospital
state: Shanghai
Study officials:
affiliation: Shang hai Tenth People's Hospital, Shanghai, Shanghai, China, 200072
name: Shen Qu, Dr
role: STUDY_CHAIR
References:
citation: Cai M, Cui R, Yang P, Gao J, Cheng X, Sheng C, Li H, Sheng H, Qu S, Zhang M. Incidence and Risk Factors of Hypogonadism in Male Patients With Latent Autoimmune Diabetes and Classic Type 2 Diabetes. Front Endocrinol (Lausanne). 2021 May 31;12:675525. doi: 10.3389/fendo.2021.675525. eCollection 2021.
citation: Zhang M, Sheng C, You H, Cai M, Gao J, Cheng X, Sheng H, Qu S. Comparing the bone mineral density among male patients with latent autoimmune diabetes and classical type 1 and type 2 diabetes, and exploring risk factors for osteoporosis. J Endocrinol Invest. 2021 Aug;44(8):1659-1665. doi: 10.1007/s40618-020-01472-6. Epub 2021 Jan 2.