NCT04618354

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
632

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2019

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

October 31, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 5, 2020

Completed
25 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2020

Completed
Last Updated

September 13, 2022

Status Verified

September 1, 2022

Enrollment Period

1.9 years

First QC Date

October 31, 2020

Last Update Submit

September 8, 2022

Conditions

Diabetes

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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 Outcomes (11)

  • HbA1c

    2016-2021

  • FBG

    2016-2021

  • PBG

    2016-2021

  • FINS

    2016-2021

  • PINS

    2016-2021

  • +6 more secondary outcomes

Study Arms (3)

LADA group

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

Other: No interventions

T2DM group

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

Other: No interventions

T1DM group

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

Other: No interventions

Interventions

No interventionsOTHER

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

LADA groupT1DM groupT2DM group

Eligibility Criteria

Age30 Years - 80 Years
Sexmale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

600 diabetes Patients from Shanghai Tenth People's Hospital were enrolled in this study.

You may qualify if:

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

You may not qualify if:

  • 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.
  • ）a history of congenital/hypogonadotropic hypogonadism or hyperthyroidism, or those who received testosterone replacement therapy in the past 6 months were excluded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Endocrinology, Shanghai Tenth People's Hospital

Shanghai, Shanghai Municipality, 200070, China

Location

Related 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.

    PMID: 34135863BACKGROUND

  • 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.

    PMID: 33387352BACKGROUND

Related Links

Biospecimen

Retention: NONE RETAINED

Take a blood sample from the patient and extract serum from it for testing

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Shen Qu, Dr

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

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director, Principal Investigator, Clinical Professor

Study Record Dates

First Submitted

October 31, 2020

First Posted

November 5, 2020

Study Start

January 1, 2019

Primary Completion

November 30, 2020

Study Completion

December 30, 2020

Last Updated

September 13, 2022

Record last verified: 2022-09

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)