NCT01705639已完成3 期
Does Melatonin Treatment Affect Glucose Tolerance Among Individuals With a Variant (rs10830963) of the Melatonin Receptor 1B (MTNR1B) Gene?
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 45
- 试验地点
- 2
- 主要终点
- Glucose tolerance
研究概览
简要总结
The effect of 3 months of melatonin 4mg treatment on glucose tolerance in different variants of the melatonin receptor 1B gene will be evaluated. The following will be done at 0 and 3 months:
- OGTT
- questionnaires about sleep and activity
- Actigraph
- Anthropometry
- Blood pressure
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
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •signed informed concent
- •Known genotype for MTNR1B from the Botnia-ppp study
- •Age 18-75 years
排除标准
- •Positive GAD-ab
- •Sever dysregulated hypertension
- •severe coronary heart disease or arrythmias
- •previous or ongoing severe ventricle or duodenal ulcer
- •psychosis or anxiety disorder
- •regular use of sleep pills, antidepressants or neuroleptics
- •creatinine > 130 µmol/L
- •elevated liver enzymes (ASAT, ALAT, ALP, GT, bilirubin) > 3 times reference value
- •inability to sign informed concent
- •other factor with according to the physician may affect treatment or results.
- •participation in other clinical study
- •allergy to melatonin or other substance in the capsule
- •hereditary galactose intolerance or glucose/galactose malabsorption
- •intention to become pregnant
研究组 & 干预措施
Melatonin
Experimental
melatonin 4mg od for 3 months
干预措施: Melatonin (Drug)
结局指标
主要结局
Glucose tolerance
时间窗: 3 months
Glucose tolerance is measured in OGTT: 0,30,60,90 and 120 minute values of glucose and insulin.
次要结局
- sleep(3 months)
- Activity(3 months)
研究者
Tom Forsén
MD PhD
University of Helsinki
研究点 (2)
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