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临床试验/NCT07099937
NCT07099937尚未招募不适用

Metabolic Syndrome and Thyroid Dysfunction in Type 2 Diabetes In Upper Egypt

Assiut University0 个研究点目标入组 120 人开始时间: 2025年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
120
主要终点
Prevalence of thyroid dysfunction among type 2 diabetic patients

研究概览

简要总结

Evaluate the expression of glycemic parameters, lipid profile, and thyroid hormones in patients with type 2 diabetes mellitus in upper egypt.

详细描述

Type 2 diabetes mellitus (T2DM) is a chronic metabolic disorder characterized by insulin resistance and impaired insulin secretion, resulting in persistent hyperglycemia. ( )..In T2DM, the response to insulin is diminished, and this is defined as insulin resistance. During this state, insulin is ineffective and is initially countered by an increase in insulin production to maintain glucose homeostasis, but over time, insulin production decreases, resulting in T2DM.( ).

Glycemic parameters are critical indicators for diagnosing and monitoring diabetes mellitus. The most commonly used measures include fasting blood glucose (FBG), postprandial blood glucose (PPBG), and glycated hemoglobin (HbA1c). Among them, HbA1c reflects the average blood glucose levels over the previous two to three months and is considered a reliable marker of chronic hyperglycemia.( ) Diabetic dyslipidemia constitutes a distinct cluster of plasma lipid and lipoprotein abnormalities that are metabolically interconnected in individuals with type 2 diabetes mellitus. This condition is predominantly characterized by elevated triglyceride (TG) concentrations, reduced levels of high-density lipoprotein cholesterol (HDL-C) ( ).

The underlying mechanism involves insulin resistance, which disrupts normal lipid metabolism by enhancing hepatic very low-density lipoprotein (VLDL) synthesis and impairing the clearance of triglyceride-rich lipoproteins. ( ) Prevalence of thyroid dysfunction is greater in diabetes patients compared to the general population.1-3 Prevalence of thyroid dysfunction in general population is around 6.6-13.4%, while in diabetes population around 10-24%.1 Studies found that subclinical hypothyroidism is the most common thyroid dysfunction in diabetic population ( ) Emerging evidence suggests a complex interplay between glycemic control, lipid metabolism, and thyroid function in patients with type 2 diabetes mellitus. Poor glycemic control has been associated with adverse lipid profiles and alterations in thyroid hormone levels, which may collectively contribute to the progression of diabetic complications. Thyroid hormones influence both glucose and lipid metabolism by regulating hepatic glucose production, lipolysis, and insulin sensitivity. ( ).

This study was conducted in Upper Egypt, a region characterized by distinct sociodemographic and health profiles compared to other parts of the country. Despite the growing burden of non-communicable diseases, including type 2 diabetes, there is a noticeable lack of regional epidemiological data addressing the coexistence of metabolic syndrome and thyroid dysfunction. Investigating this relationship in the Upper Egypt population may help fill existing knowledge gaps and support the development of more effective, geographically tailored healthcare strategies.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Cross Sectional

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
否

入选标准

  • •Patients diagnosed with type 2 diabetes mellitus in upper egypt.
  • •Age above 18 years.
  • •Patients who gave informed consent to participate.

排除标准

  • •Patients with type 1 diabetes mellitus.
  • •Age below 18 years.
  • •Patients with known autoimmune thyroid diseases, pregnancy, or acute illness at the time of assessment.

结局指标

主要结局

Prevalence of thyroid dysfunction among type 2 diabetic patients

时间窗: Baseline

The outcome will measure the proportion (%) of type 2 diabetic patients diagnosed with thyroid dysfunction. This includes classification into hypothyroidism, hyperthyroidism, subclinical hypothyroidism, and subclinical hyperthyroidism based on standard laboratory cutoffs of TSH, free T3, and free T4.

Association between thyroid dysfunction and metabolic syndrome in type 2 diabetic patients

时间窗: Baseline

The outcome will assess the statistical correlation (e.g., chi-square test or logistic regression) between the presence of thyroid dysfunction and the diagnosis of metabolic syndrome, according to IDF criteria. Results will be reported as odds ratios or p-values as appropriate.

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

Ghada Ragab Hamed Abdelnasser

doctor

Assiut University

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