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临床试验/CTRI/2024/03/063798
CTRI/2024/03/063798尚未招募不适用

Correlation between serum iron and inflammatory markers with hypothyroidism and its associated metabolic comorbidities

Monit sundriyal1 个研究点 分布在 1 个国家目标入组 482 人开始时间: 2024年3月14日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
482
试验地点
1
主要终点
1)BMI, lipid profile, and inflammatory marker levels may elevate in subclinical hypothyroidism, hypothyroidism, and associated disorders.

研究概览

简要总结

Thyroid disease is one of the most prevalent Endocrinological Disorders in India, and around the world, it affects more than 200 million people. The incidence of Thyroid gland disorders is 10 - 15% more advanced in the female population in comparison with the male population**;** the Prevalence of thyroid diseases is around 15 - 25% in various regions of India, while developed countries have a prevalence of about 4-9% only. Jharkhand which is an iodine deficient state, the proportion of thyroid disorder is 6% population affected by overt hypothyroidism, while 13.7% affected by subclinical hypothyroidism (SCH), and 6.3% population affected by hyperthyroidism and its other types. Jharkhand state is considered an iodine-deficient belt, due to which thyroid disorders are more prevalent. Anaemia cases are commonly present due to low socio-economic status and low nutritional diet in the Jharkhand population.  Hypothyroidism, if not treated, can become a risk factor for anemia and may lead to developing cardiovascular disorders and chronic kidney diseases.  The aim of the study will be: To Evaluate the correlation between Iron status, dyslipidemia, Oxidative Stress, & inflammatory markers on hypothyroidism and its associated disorders. The study will be a case-control study, Results will be reported as a mean and standard mean error with the help of statistical software GraphPad Prism 5, Pearson correlation method will be used to find the correlation between biochemical parameters and their association disorders.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 70.00 Year(s)(—)
性别
All

入选标准

  • i)Age group between (
  • 70 years) will be included in the study. ii)Patients diagnosed with overt, subclinical hypothyroidism with or without CVD or/CKD metabolic comorbidities. iii) Controls with euthyroidism without CVD, CKD or autoimmune disorder, inflammatory diseases like (Hashimoto’s thyroiditis, Rheumatoid arthritis and Lupus) immune-compromised will be taken in the study.

排除标准

  • i) Study participants less than 18 years & women with pregnancy will not be included.
  • ii)The study will not include patients on medication with antithyroid drugs, lipid-lowering drugs, antihypertensives, or any other steroids for inflammatory diseases.
  • iii) Patients and healthy controls on antioxidant supplementation or other supplements that affect oxidative stress will be excluded from the study.

结局指标

主要结局

1)BMI, lipid profile, and inflammatory marker levels may elevate in subclinical hypothyroidism, hypothyroidism, and associated disorders.

时间窗: 1)BMI, lipid profile, and inflammatory marker levels may elevate in subclinical hypothyroidism, hypothyroidism, and associated disorders. (6 months) | 2)Smoking and alcohol may increase the lipid profile & inflammatory marker levels in hypothyroidism patients and associated disorders.(6 months) | 3)Total blood cell counts and iron profile levels may alter in hypothyroidism. (6 months)

2)Smoking and alcohol may increase the lipid profile & inflammatory marker levels in hypothyroidism patients and associated disorders.

时间窗: 1)BMI, lipid profile, and inflammatory marker levels may elevate in subclinical hypothyroidism, hypothyroidism, and associated disorders. (6 months) | 2)Smoking and alcohol may increase the lipid profile & inflammatory marker levels in hypothyroidism patients and associated disorders.(6 months) | 3)Total blood cell counts and iron profile levels may alter in hypothyroidism. (6 months)

3)Total blood cell counts and iron profile levels may alter in hypothyroidism.

时间窗: 1)BMI, lipid profile, and inflammatory marker levels may elevate in subclinical hypothyroidism, hypothyroidism, and associated disorders. (6 months) | 2)Smoking and alcohol may increase the lipid profile & inflammatory marker levels in hypothyroidism patients and associated disorders.(6 months) | 3)Total blood cell counts and iron profile levels may alter in hypothyroidism. (6 months)

次要结局

  • Total blood cell count and iron profile levels may alter in hypothyroidism.

研究者

发起方
Monit sundriyal
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Monit sundriyal

Manipal Tata medical college

研究点 (1)

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