Study OF thyroid hormones and early Predictive Biomarkers in hypothyroidism.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 110
- 试验地点
- 1
- 主要终点
- The ability of serum reverse T3 and FT3/FT4 ratio to predict progression from subclinical hypothyroidism to overt hypothyroidism.
研究概览
简要总结
BackgroundSubclinical hypothyroidism (SCH) is characterized by elevated thyroid-stimulating hormone (TSH) levels with normal free thyroxine (FT4) and free triiodothyronine (FT3). Identifying early biochemical markers that can improve diagnosis, predict progression, or guide treatment decisions is crucial. Serum reverse T3 (rT3), an inactive thyroid hormone metabolite, and the FT3/FT4 ratio may reflect peripheral thyroid hormone metabolism more accurately than conventional parameters.
AimTo evaluate the diagnostic and predictive utility of serum reverse T3 and the FT3/FT4 ratio in identifying and stratifying subclinical hypothyroidism.
Objectives
- Compare serum reverse T3 levels in euthyroid and subclinical hypothyroid individuals.
- Calculate and assess FT3/FT4 ratio in both groups.
- Evaluate the correlation between rT3 and FT3/FT4 ratio.
- Determine the diagnostic sensitivity, specificity, and predictive accuracy of these markers using ROC curve analysis.
- Explore their role in enhancing early detection and risk stratification of SCH.
Study Design
-
Type: Analytical, observational, case-control study
-
Groups:
-
Group A: Subclinical hypothyroid patients (TSH > normal, FT4 and FT3 normal)
-
Group B: Age- and sex-matched euthyroid controls
-
Sample Size: 110 participants (55 per group), calculated to ensure power for group comparison and ROC analysis.
Inclusion Criteria
- Adults aged 18–65 years
- Newly diagnosed with SCH (for cases)
- Euthyroid status confirmed within 3 months (for controls)
Exclusion Criteria
- Overt thyroid disorders
- Chronic illnesses, pregnancy, or medications affecting thyroid function
- Recent acute illness
Data Collection & Analysis
- Measure TSH, FT3, FT4, and reverse T3 using standardized assays
- Calculate FT3/FT4 ratio
- Statistical analysis: independent t-tests, correlation analysis, ROC curves (AUC
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 13.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients aged 13 to 60 years Normal FT3 and FT4 levels TSH between 4.5–10 mIU/L (indicative of subclinical hypothyroidism).
排除标准
- •Overt hypothyroidism or hyperthyroidism Current use of thyroid hormone replacement or anti-thyroid drugs History of major systemic illness (e.g., liver disease, renal disease, malignancy) Pregnant or lactating women Patients on corticosteroids or medications affecting thyroid function.
结局指标
主要结局
The ability of serum reverse T3 and FT3/FT4 ratio to predict progression from subclinical hypothyroidism to overt hypothyroidism.
时间窗: At Baseline
次要结局
- Correlation between rT3 & FT3/FT4 ratio with TSH levels & clinical parameters of thyroid dysfunction in SCH patients.(At Baseline)
研究者
Shesharam Patel
Govt. Medical College Pali Rajasthan