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A prospective randomized controlled study of thyrotropin levels in type 2 diabetes mellitus in the pathogenesis and prognosis of diabetic cardiomyopathy

A prospective randomized controlled study of thyrotropin levels in type 2 diabetes mellitus in the pathogenesis and prognosis of diabetic cardiomyopathy

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500103553
Enrollment
Unknown
Registered
2025-05-30
Start date
2024-01-06
Completion date
Unknown
Last updated
2025-06-02

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

Conditions

Type 2 diabetes mellitus with subclinical hypothyroidism,diabetic cardiomyopathy

Interventions

T2DM combined with SCH and thyroid hormone therapy intervention group:L-Thyroxine
Control group with T2DM and normal thyroid function:None
T2DM combined with SCH blank control group:None

Sponsors

Tongji Hospital of Tongji University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1.T2DM patients WHO meet WHO diagnostic criteria for diabetes and have normal thyroid function or subclinical hypothyroidism; 2.Age greater than or equal to 18 years old; 3.Voluntarily sign the informed consent form;

Exclusion criteria

Exclusion criteria: 1.These include hypertensive heart disease, coronary atherosclerotic heart disease, valvular heart disease, congenital heart disease, viral cardiomyopathy or familial cardiomyopathy; 2.Combined thyroid disease (hyperthyroidism, clinical hypothyroidism, subacute thyroiditis, etc.), taking drugs that may affect thyroid function (such as thyroid hormones, iodinated preparations, glucocorticoids, etc.), history of thyroid surgery or external irradiation; 3.Patients with malignant tumors receiving radiotherapy and chemotherapy; 4.Patients with severe liver and kidney function impairment, rheumatic immune system diseases, blood system diseases and malignant tumors have lesions in the hypothalamus, pituitary gland and sella region; 5.Type 1 diabetes mellitus, specific type diabetes mellitus, acute complications of diabetes mellitus; 6.Sepsis and other acute infection, trauma, surgical period; 7.Pregnant and lactating women; 8.Bipolar disorder, schizophrenia and other severe psychiatric patients and patients with cognitive dysfunction; 9.Allergic to levothyroxine sodium.

Design outcomes

Primary

MeasureTime frame
Prevalence of diabetic cardiomyopathy;

Secondary

MeasureTime frame
Changes in cardiac structure and function of subjects relative to baseline;

Countries

China

Contacts

Public ContactYing Xue

Tongji Hospital of Tongji University

doxy0622@163.com+86 21 66111060

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026