Impact of Thyroid Hormones on Human Glucose and Energy Metabolism
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Insulin secretion
研究概览
简要总结
The goal of this clinical trial to clarify the impact of changes in thyroid hormone levels on glucose and lipid metabolism.
Patients will be included in whom thyroid hormone levels are intentionally changed by treatment. In patients with Graves' disease, thyroid hormone levels will be lowered using medication, while in patients with thyroid cancer, thyroid hormone levels will be raised using medication. Oral glucose tolerance tests will be performed before treatment and at two time points after treatment begins to assess metabolic effects.
详细描述
This research project aims to clarify the role of changes in thyroid hormone levels in glucose and liver metabolism.
Thyroid hormones regulate endogenous glucose production, insulin sensitivity, lipid metabolism, and lipid storage in the liver. They also appear to enhance insulin sensitivity in other tissues. Furthermore, thyroid hormones stimulate lipolysis and reduce total and LDL-cholesterol levels. The impact of thyroid hormones on insulin secretion is controversial, with some trials demonstrating increased secretion and others showing decreased secretion. Most of this evidence is derived from animal trials, and prospective human trials are lacking.
Clinical scenarios where thyroid hormone levels are altered through therapeutic interventions will be used. In patients with Graves' disease, hyperthyroidism is pharmacologically reduced, whereas in patients with thyroid carcinoma, hyperthyroidism is pharmacologically induced. Before the start of treatment, two weeks and three months after start of treatment oral glucose tolerance tests will be performed for metabolic characterization. Using this approach, differences in glycemic, insulin sensitivity, insulin secretion, lipids, resting energy expenditure, respiratory quotient, hepatic steatosis, eating and exercise behavior will be assessed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients with initial diagnosis of graves disease OR
- •patients with initial diagnosis of thyroid carcinoma
排除标准
- •contraindications for oral glucose tolerance test
- •Diabetes mellitus
- •Fasting glucose level ≥ 200 mg/dL
- •Exogenous insulin administration with action at the time of the test
- •Current disease with activation of stress hormones
- •Post-aggressive metabolism
- •Acute infectious disease
研究组 & 干预措施
Phenotyping Cohort
Patients with Graves' disease and patients with thyroid carcinoma undergoing standard-of-care thyroid treatment.
干预措施: Oral Glucose Tolerance Test (Other)
结局指标
主要结局
Insulin secretion
时间窗: Baseline, 2 weeks, 3 months
Effect of changes in thyroid hormone levels on insulin secretion, assessed from glucose and insulin/c-peptide measurements during the 75 g oral glucose tolerance test.
Insulin sensitivity
时间窗: Baseline, 2 weeks, 3 months
Effect of changes in thyroid hormone levels on whole-body insulin sensitivity, assessed from glucose and insulin measurements during the 75 g oral glucose tolerance test.
次要结局
- Hepatic steatosis(baseline)
- Resting energy expenditure.(Baseline, 2 weeks, 3 months)
- Respiratory Quotient(Baseline, 2 weeks, 3 months)
- Lipid metabolism(Baseline, 2 weeks, 3 months)
- Heart rate variability(Baseline, 2 weeks, 3 months)
- Eating behavior(Baseline, 3 months)
研究者
Martin Heni
Prof. Dr. med. Martin Heni
University of Ulm