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Completed

NCT Number: NCT04618354

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

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.

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Key information

Age range

30 year–80 year

Sex eligibility

Male

Study type

Observational

Primary location

Department of Endocrinology, Shanghai Tenth People's Hospital

Shanghai, Shanghai Municipality, 200070, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

No interventions

Other

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

Primary outcomes

  1. Testosterone

    Time frame: 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

  2. Bone mineral density

    Time frame: 2016-2021

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

Secondary outcomes

  1. HbA1c

    Time frame: 2016-2021

    Glycosylated hemoglobin A1c

  2. FBG

    Time frame: 2016-2021

    patients with fasting blood glucose 6.1mmol/l or more

  3. PBG

    Time frame: 2016-2021

    patients with 2 hour blood glucose 7.8mmol/l or more

  4. FINS

    Time frame: 2016-2021

    metabolic profile fasting insulin (IU/L)

  5. PINS

    Time frame: 2016-2021

    patients with 2 hour blood insulin

  6. TC

    Time frame: 2016-2021

    metabolic profile Total cholesterol (mmol/L)

  7. TG

    Time frame: 2016-2021

    metabolic profile Triglycerides (mmol/L)

  8. HDL-c

    Time frame: 2016-2021

    metabolic profile high-density lipoprotein cholesterol (mmol/L)

  9. LDL-c

    Time frame: 2016-2021

    metabolic profile Low-density lipoprotein cholesterol (mmol/L)

  10. FSH

    Time frame: 2016-2021

    follicle-stimulating hormone

  11. LH

    Time frame: 2016-2021

    luteinizing hormone

Sponsors and collaborators

Lead sponsor

Shanghai 10th People's Hospital

Other

Registry information

Official study title

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

Acronym: LADA

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Nov 5, 2020
Registry last updated
Sep 13, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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