Effect of Life Style Modification and Metformin on Hypothyroidism With Insulin Resistance
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 100
- 主要终点
- Dose of levothyroxine
研究概览
简要总结
The aim of the study is the effect of lifestyle modification and metformin on hypothyroidism with insulin resistance
详细描述
Hypothyroidism happens when the thyroid does not create and release enough thyroid hormone in the body this make the metabolism slow down .
Thyroid hormones T3 and T4 maintain a fine balance of glucose homeostasis by acting as insulin agonistic and antagonistic. Hypothyroidism can break this equilibrium and alter glucose metabolism, which can lead to insulin resistance.
Insulin resistance is defined clinically as the inability of a known quantity of exogenous or endogenous insulin to increase glucose uptake and utilization in an individual as much as it does in a normal population.
In this work we assess the lifestyle modification (i.e. diet and exercise)and metformin on insulin resistance
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •1_ above 18 years with insulin resistance criteria according (The American Association of Clinical Endocrinologists (AACE)
- •BMI of 25 kg/m2 or higher
- •Waist circumference of more than 102 cm in men or more than 88 cm in women
- •Triglyceride level of 150 mg/dl . or higher.
- •HDL-C level of less than 40 mg/dl in men or less than 50 mg/dl in women
- •Blood pressure of 130 /85 mmhg or higher
- •Fasting glucose level of 110 ـ126 mg /dl
- •Glucose level of more than 140 mg/dl2 hour after administration of 75 g of glucose
- •2_ Patients known to have hypothyroidism and achieving diagnostic criteria of insulin resistance
排除标准
- •Patients don't have other secondary causes of insulin resistance i.e. acromegaly, Cushing syndrome 3- patient have renal or hepatic impairment (contraindication to metformin )
研究组 & 干预措施
metformin ,life style
known to have hypothyroidism with insulin resistance received metformin (1000mg,once daily per oral ) and applied life style modification
干预措施: Metformin (Drug)
结局指标
主要结局
Dose of levothyroxine
时间窗: 6 months
change of the dose of levothyroxine
change of parameter of metabolic syndrome
时间窗: 6 months
change of score of parameter of metabolic syndrome
change of waist circumference
时间窗: 6 months
change of waist circumference from baseline and at the end of study
次要结局
未报告次要终点
研究者
Mohammad Hasan AbdEllah
principal investigator
Assiut University