The Role of Insulin Resistance and the Effect of Metformin Use on Volume of Benign Thyroid Nodules
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- changes in nodule volume from baseline after metformin use
研究概览
简要总结
It has been shown that insulin might be involved in the pathogenesis of thyroid growth.
Objective To evaluate the impact of IR and metformin use on the volume of benign thyroid nodules (TNs).
Methods A randomized clinical trial to placebo (P) or MTF use. Previous fine needle aspiration confirming the diagnosis is necessary to inclusion. Patients will receive similar tablets of MTF and placebo and instruct to take 3 tablets/day of MTF (500mg/tablet). Thyroid volume, as TN volume, will be assess by ultrasound, both in the beginning, six months and one year after randomization, by the same researcher blinded regarding location group. Blood samples to measure: TSH, FT4, TPO-Ab, lipid profile, glucose and insulin were done after 8h fasting.
详细描述
It has been shown that insulin might be involved in the pathogenesis of thyroid growth. Previous studies suggest that metformin (MTF) therapy decreased thyroid volume and nodule size in subjects with insulin resistance (IR).
Objectives To evaluate the impact of IR and metformin use on the volume of benign thyroid nodules (TNs).
Methods A randomized clinical trial to placebo (P) or MTF use. Previous fine needle aspiration confirming the diagnosis is necessary to inclusion. Exclusion criteria were: nodules with a predominantly cystic pattern, pregnancy, diabetes, acromegaly, previous use of MTF, levothyroxine, corticoid or any weight loss medication in the past six months, hepatic or cardiac insufficiency, creatinine levels > 1.4 mg/dL and MTF intolerance doses >1.0 gram/day. Patients will receive similar tablets of MTF and placebo and will be instructed to take 3 tablets/day of MTF (500mg/tablet). Thyroid volume, as TN volume, will be accessed by ultrasound, both in the beginning, six months and one year after randomization, by the same researcher blinded regarding location group. Blood samples to measure: TSH, FT4, TPO-Ab, lipid profile, glucose and insulin were done after 8h fasting.
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 (Participant, Outcomes Assessor)
盲法说明
The same researcher blinded regarding location group will access thyroid volume and thyroid nodule volume by ultrasound, in the beginning, six months and one year after randomization
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •patients with benign nodules diagnosed by fine needle aspiration biopsy (FNAB)
排除标准
- •Nodules with a predominantly cystic pattern
- •Eggshell calcification
- •Coalescent thyroid nodules (not suitable for size analysis)
- •Pregnancy
- •Acromegaly
- •Previous use of MTF, levothyroxine, corticoid or any weight loss medication in the past six months
- •Hepatic or cardiac insufficiency
- •Creatinine levels > 1.4 mg/dL
- •MTF intolerance doses < 1.0 gram/day
研究组 & 干预措施
Metformin
patients randomized to Metformin group
干预措施: Metformin (Drug)
Placebo
patients randomized to placebo group
干预措施: Placebo (Drug)
结局指标
主要结局
changes in nodule volume from baseline after metformin use
时间窗: one year
the impact of metformin on the volume of thyroid nodules
次要结局
- changes in nodule volume from baseline and changes in homa-ir(one year)
- changes in TSH levels from baseline after metformin use(one year)
研究者
Patricia Borges dos Santos
Principal Investigator
Hospital Universitário Clementino Fraga Filho