Study of glycemic abnormalities, beta cell function and insulin sensitivity in patients with transfusion dependent Thalassemia major : Cross sectional study.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Prevalence of glycemic abnormalities
研究概览
简要总结
This cross-sectional observational study aims to evaluate glycemic abnormalities in paediatric patients with age group between 1 to 18 years with transfusion dependent thalassemia major attending a tertiary care hospital. The primary outcome will be prevalance and pattern of glycemic abnormalities in this population. Secondary outcomes include assessment of beta cell function, estimation of insulin resistance, correlation with serum ferritin levels, and comparison of fructosamine with HbA1c as markers of glucose metabolism. This study is expected to provide valuable insights into the burden and predictors of abnormal glucose regulation in thalassemia major and may help establish simple screening tools for early detection and prevention of diabetes in this high risk group.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 1.00 Year(s) 至 18.00 Year(s)（—）
- 性别
- All
入选标准
- •: Pediatric patients aged 1-18 years with transfusion dependent thalassemia with atleast 1 year since time of diagnosis who consent to be a part of the study.
排除标准
- •Known diabetic patients, those on insulin or oral hypoglycemic agents
- •Those with other significant systemic illnesses like cardiac failure, viral hepatitis, hepatocellular carcinoma and other neoplasias.
- •Those receiving hepatotoxic drugs
- •Those with syndromic illnesses.
结局指标
主要结局
Prevalence of glycemic abnormalities
时间窗: Single assessment at baseline
次要结局
- Evaluation of beta cell function(Single assessment at baseline)
- Assessment of insulin sensitivity/resistance(Single assessment at baseline)
- Correlation of glycemic abnormalities and insulin resistance with serum ferritin levels(Single assessment at baseline)
- Comparison of fructosamine levels with HbA1c for detection of glucose abnormalities(Single assessment at baseline)
研究者
DR POOJA PATIL
KAHERs JAWAHARLAL NEHRU MEDICAL COLLEGE