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

NCT ID: NCT04618354

Last Updated: 2022-09-13

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 632 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-01-01
• Study Completion Date: 2020-12-30

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.

Conditions

Diabetes

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: RETROSPECTIVE

Study Groups

LADA group

The patient was diagnosed with late-onset autoimmune diabetes (LADA).

No interventions

Intervention Type: OTHER

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

T2DM group

The patient was diagnosed with type 2 diabetes (T2DM).

No interventions

Intervention Type: OTHER

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

T1DM group

The patient was diagnosed with type 1 diabetes (T1DM).

No interventions

Intervention Type: OTHER

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

Interventions

No interventions

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

Intervention Type: OTHER

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.

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Shanghai 10th People's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Zhang Manna

Director, Principal Investigator, Clinical Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Shen Qu, Dr

Role: STUDY_CHAIR

Shang hai Tenth People's Hospital, Shanghai, Shanghai, China, 200072

Locations

Department of Endocrinology, Shanghai Tenth People's Hospital

Shanghai, Shanghai Municipality, China

Countries

China

References

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.

Reference Type: BACKGROUND

PMID: 34135863 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 33387352 (View on PubMed)

Related Links

http://pubmed.ncbi.nlm.nih.gov/34135863/

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

http://pubmed.ncbi.nlm.nih.gov/33387352/

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

Other Identifiers

LADA

Identifier Type: -

Identifier Source: org_study_id