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

Diabetes Clinical Trial

— LADA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04618354
• Other study ID #: LADA
• Status: Completed
• Start date: January 1, 2019
• Est. completion date: December 30, 2020

Study information

• Verified date: September 2022
• Source: Shanghai 10th People's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 632
• Est. completion date: December 30, 2020
• Est. primary completion date: November 30, 2020
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 30 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes

Intervention

Other:
• No interventions
This clinical study is a retrospective study, and no interventions have been implemented for patients.

Locations

Country	Name	City	State
China	Department of Endocrinology, Shanghai Tenth People's Hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai 10th People's Hospital

Country where clinical trial is conducted

China, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

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

External Links

•   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
•   Incidence and Risk Factors of Hypogonadism in Male Patients With Latent Autoimmune Diabetes and Classic Type 2 Diabetes