Effect of levothyroxine replacement on lipid profile,anti TPO-antibody,hs-CRP levels in newly diagnosed cases of hypothyroidism
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- 3.hsCRP Levels: Elevated hsCRP is indicative of increased inflammation and is associated with various cardiovascular risks. The study aims to discern whether Levothyroxine treatment influences hsCRP levels, potentially indicating a reduction in inflammation and related risks.
研究概览
简要总结
Background: Hypothyroidism is acommon endocrine disorder with systemic implications, including adverse effectson lipid metabolism, immune function, and inflammation. This research proposaloutlines a study evaluating the impact of Levothyroxine replacement therapy onkey clinical parameters in newly diagnosed cases of hypothyroidism.
Methods: The study will beconducted at Acharya Vinoba Bhave Rural Hospital for two years, from July 2022to July 2024, employing a cross-sectional study design. Eligible participantswill be identified based on clinical features and confirmed through thyroidprofile reports. Exclusion criteria will be applied to ensure the homogeneityof the study population.
Data Collection: Data will be collectedthrough comprehensive assessments, including history taking, clinicalexamination, and laboratory investigations. Laboratory tests will encompasslipid profiles, thyroid function tests, high-sensitivity C-Reactive Protein(hs-CRP) levels, and Anti-Thyroid Peroxidase Antibody (Anti-TPO Ab) levels.
Excepted result: In this study, weanticipate that Levothyroxine replacement therapy in newly diagnosed cases ofhypothyroidism will result in favorable changes in crucial health markers. Weexpect to observe improvements in the lipid profile, with reductions in totalcholesterol and LDL cholesterol and an increase in beneficial HDL cholesterol,indicating a positive impact on cardiovascular risk factors. Additionally, weanticipate a decrease in anti-thyroid peroxidase Antibody (Anti-TPO Ab) levels,suggesting a potential amelioration of the autoimmune aspect of hypothyroidism.Furthermore, we expect a reduction in high-sensitivity C-Reactive Protein(hs-CRP) levels, indicating a potential reduction in inflammation andassociated cardiovascular risks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Other
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 18.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients with clinical features suggestive of hypothyroidism and diagnosis made as per report of thyroid profile.
排除标准
- •Patients who were not on any thyroid supplement.
- •Patients on antithyroid drugs( carbimazole, methimazole, propylthiouracil)
- •DM (Diabetes mellitus).
- •CAD (Coronary artery disease).
- •Critically ill patients.
- •CKD( chronic kidney disease).
结局指标
主要结局
3.hsCRP Levels: Elevated hsCRP is indicative of increased inflammation and is associated with various cardiovascular risks. The study aims to discern whether Levothyroxine treatment influences hsCRP levels, potentially indicating a reduction in inflammation and related risks.
时间窗: the data will be assessed between the time period of 1.5 years,i.e:01/09/2022 to 31/03/2024
1.Lipid Profile Improvement: The study will evaluate whether Levothyroxine treatment leads to significant changes in these lipid parameters, potentially demonstrating improvements in cardiovascular risk factors.
时间窗: the data will be assessed between the time period of 1.5 years,i.e:01/09/2022 to 31/03/2024
2.Anti-TPO Antibody Levels: This assessment aims to determine whether Levothyroxine replacement therapy has any discernible effect on the autoimmune component of hypothyroidism by monitoring the Anti-TPO Ab levels over the course of the study.
时间窗: the data will be assessed between the time period of 1.5 years,i.e:01/09/2022 to 31/03/2024
次要结局
- as per the literature review available the correlation with levels of lipid Profile, anti-TPO antibody, and hsCRP with the treatment of newly diagnosed hypoparathyroidism will be positive(1.5 years)