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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04618354
Acronym
LADA
Enrollment
632
Registered
2020-11-05
Start date
2019-01-01
Completion date
2020-12-30
Last updated
2022-09-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes

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.

Interventions

OTHERNo interventions

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

Sponsors

Shanghai 10th People's Hospital
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
MALE
Age
30 Years to 80 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Testosterone2016-2021total testosterone (nmol/L), testosterone (nmol/L) and SHBG (nmol/L). Hypogonadism was defined as total testosterone levels less than 3.0 ng/ml
Bone mineral density2016-2021Bone mineral density was measured at the lumbar spine, femoral neck, and right hip by dual-energy x-ray absorptiometry (DXA)

Secondary

MeasureTime frameDescription
PBG2016-2021patients with 2 hour blood glucose 7.8mmol/l or more
FINS2016-2021metabolic profile fasting insulin (IU/L)
PINS2016-2021patients with 2 hour blood insulin
TC2016-2021metabolic profile Total cholesterol (mmol/L)
HbA1c2016-2021Glycosylated hemoglobin A1c
HDL-c2016-2021metabolic profile high-density lipoprotein cholesterol (mmol/L)
LDL-c2016-2021metabolic profile Low-density lipoprotein cholesterol (mmol/L)
FSH2016-2021follicle-stimulating hormone
LH2016-2021luteinizing hormone
TG2016-2021metabolic profile Triglycerides (mmol/L)
FBG2016-2021patients with fasting blood glucose 6.1mmol/l or more

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026