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临床试验/NCT07343648
NCT07343648尚未招募不适用

Assessment of Antithyroglobulin Antibody Levels Among Diabetic Patients

Assiut University0 个研究点目标入组 112 人开始时间: 2026年2月1日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
112
主要终点
the levels of anti-thyroglobulin (anti-Tg) antibodies among diabetic patients .

研究概览

简要总结

Assessment of antithyroglobulin antibody (anti Tg) level among diabetic patients explores the intersection between autoimmune thyroid disease and diabetes mellitus. Autoimmune thyroiditis and diabetes frequently coexist, and anti Tg is one of the main markers used to document thyroid autoimmunity.(1,2) Thyroglobulin is a large iodinated glycoprotein produced by thyroid and serves as the precursor for thyroid hormone synthesis. Damage to thyroid tissue in autoimmune thyroiditis leads to production of autoantibodies against thyroglobulin (Tg)(1,3). Anti Tg is therefore considered serologic hallmarks of autoimmune thyroiditis. The presence of this antibody may also be used to monitor thyroid damage progression and predict the development of overt hypothyroidism in at risk populations(1,3).

Type 1 diabetes mellitus (T1DM) is an organ specific autoimmune. Because of shared genetic susceptibility and overlapping immune mechanisms, patients with T1DM have a markedly increased prevalence of autoimmune thyroiditis compared with the general population. International guidelines support routine screening for thyroid autoantibodies and thyroid function in T1DM to enable early detection of subclinical thyroid dysfunction(2,4).

. A study reported that, among 60 T1DM patients without known thyroid disease, 16.7% were positive for anti Tg, and subclinical or overt hypothyroidism was present in a substantial fraction of this antibody positive individuals. Other series similarly show that thyroid autoantibodies are common in T1DM and that their presence predicts later thyroid dysfunction. (5,6).

Increasing evidence indicates that type 2 diabetes mellitus (T2DM) is also associated with a higher prevalence of thyroid autoantibodies than nondiabetic controls in many studies(1,7). In a study including 72 T2DM patients, 20.8% had either anti TPO or anti Tg positivity, and 8.3% had isolated anti Tg antibodies, with rates comparable to or higher than those reported in regional control populations. A study of female T2DM patients found anti Tg in 61.3% of cases compared with no positives in the control group, and more than half of hypothyroid diabetic patients had anti Tg positivity, suggesting a significant autoimmune contribution to thyroid dysfunction in some T2DM cohorts. (2,8).

Autoimmune clustering means that diabetic patients, are predisposed to additional organ specific autoimmune diseases, including autoimmune thyroiditis. Screening for anti Tg provides a more complete picture of thyroid autoimmunity. (2,8)

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adult aged 18-80 years, both genders.
  • established diagnosis with diabetes mellitus

排除标准

  • History of thyroid disease
  • Prior thyroid surgery
  • Current thyroid replacement or anti-thyroid medication
  • Use (within last 3 months) of drugs known to affect thyroid function or antibodies
  • Pregnancy or breast feeding

研究组 & 干预措施

cases

patients with established diagnosis with diabetes mellitus

control group

normal individual

结局指标

主要结局

the levels of anti-thyroglobulin (anti-Tg) antibodies among diabetic patients .

时间窗: baseline

the levels of anti-thyroglobulin (anti-Tg) antibodies among diabetic patients .

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Naira Ali Mohammed Soliman

residant doctor at Assiut university hospital

Assiut University

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