The Effects of Melatonin on Serum Glucose Levels of Patients With Type 2 Diabetes Mellitus
试验速览
- 阶段
- 早期 1 期
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- HbA1c
研究概览
简要总结
The aim of this study is to assess the efficacy and safety of melatonin in control of blood sugar in patients with type 2 diabetes mellitus (DM).
详细描述
Diabetes mellitus (DM) is a major public health problem with increasing worldwide incidence. The main causes for increase in incidence of DM are inactivity, obesity and changes of dietary habits. Investigators think that the changes in the awake-sleep cycle may also contribute to higher incidence of DM in recent years. Melatonin is an important component of the circadian system. Numerous experimental studies have demonstrated that melatonin has many beneficial actions.Melatonin is a potent antioxidant, reduces inflammatory process, lowers blood pressure, improve lipid profiles. Collectively, these data suggest that melatonin may be useful in control of blood sugar in patients with DM.
The aim of this study is to assess the efficacy of melatonin in control of blood sugar in patients with type 2 DM.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Type 2 diabetes mellitus diagnosed by an endocrinologist for more than six months
- •FBS=120-160mg/dl
- •HbA1C<8%
排除标准
- •Melatonin sensitivity
- •Impaired fasting glucose (IFG)
- •Impaired glucose tolerance (IGT)
- •Under Insulin therapy
- •Pregnancy
- •Lactation
- •Diabetic autonomic neuropathy and orthostatic hypotension
- •Renal failure (Creatinin>1.5mg/dl)
- •Diabetic retinopathy
- •Diabetic nephropathy
- •Malignancy
- •Alcohol use
- •Liver disease
研究组 & 干预措施
Melatonin
Melatonin 3mg once daily at bedtime
干预措施: Melatonin (Drug)
Placebo
Placebo 1 tablet once daily at bedtime
干预措施: Placebo (Drug)
结局指标
主要结局
HbA1c
时间窗: 3 months
Fasting blood sugar (FBS)
时间窗: 3 months
次要结局
- Serum Insulin(3 months)
- Serum aminotransferases(3 months)
- Waist circumference(3 months)
- Weight (Body mass index)(3 months)
- Number of patients with adverse events(3 months)
研究者
Mesbah Shams, MD
Associate professor of Internal Medicine & Endocrinology
Shiraz University of Medical Sciences