An open-labelled, randomized controlled study of levothyroxine therapy on arterial stiffness in patients with sub-clinical hypothyroidism and Type 2 diabetes mellitus
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 56
- 试验地点
- 1
研究概览
简要总结
Few studies have demonstrated that Pulse Wave Velocity ( PWV) is significantly higher in patients with overt and subclinical Hypothyroidism in comparison to euthyroid patients. However, there is very limited data in existing literature regarding effect of Levothyroxine replacement in arterial stiffness changes in patients with Type 2 Diabetes and Subclinical Hypothyroid . The current study is being undertaken to determine the effects of Levothyroxine on arterial stiffness in patients with Type 2 Diabetes Mellitus and sub clinical hypothyroidism using Oscillometric technique like the Periscope device and parameters like PWV, Aortic Augmentation Index (AIx) and Carotid femoral pulse wave velocity (cf PWV) will be used for assessment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Type 2 diabetes mellitus, diagnosed with subclinical hypothyroidism (TSH levels are above 4.0 mIU/L but below 10 mIU/L) Patient giving informed consent.
排除标准
- •Patients who are already on levothyroxine therapy or with previous history of thyroid disorders Seriously ill patients (known malignancy or patients requiring emergency management) Patients with serious infective diseases (TB HIV positive Hepatitis B and C positive etc.) Pregnant and lactating women Patients on medications like iron calcium proton pump inhibitors amiodarone etc.
- •that can interfere with levothyroxine absorption or have an effect on thyroid profile.
- •Patients with chronic kidney disease, hepatic and advanced cardiovascular diseases (h/o PTCA AV block) Patients not willing to participate in the study or provide written informed consent.
研究者
DR ARINDAM NASKAR