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

Completed

• Conditions: Diabetes
• Interventions: Other: No interventions

• Registration Number: NCT04618354
• Lead Sponsor: Shanghai 10th People's Hospital

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.

Study Timeline

• Study Start: 2019-01-01
• Study First Submitted: 2020-10-31
• Study First Submitted QC: 2020-10-31
• Study First Posted: 2020-11-05
• Primary Completion: 2020-11-30
• Study Completion: 2020-12-30
• Status Verified: 2022-09
• Last Update Submitted: 2022-09-08
• Last Update Posted: 2022-09-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 632

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
LADA group	No interventions	The patient was diagnosed with late-onset autoimmune diabetes (LADA).
T2DM group	No interventions	The patient was diagnosed with type 2 diabetes (T2DM).
T1DM group	No interventions	The patient was diagnosed with type 1 diabetes (T1DM).

Primary Outcome Measures

Name	Time	Method
Bone mineral density	2016-2021	Bone mineral density was measured at the lumbar spine, femoral neck, and right hip by dual-energy x-ray absorptiometry (DXA)
Testosterone	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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Department of Endocrinology, Shanghai Tenth People's Hospital; 🇨🇳 Shanghai, Shanghai, China