Daily Intake of Magnesium From Drinking Water in Relation to Diabetes Mellites
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 102
- 试验地点
- 3
- 主要终点
- Serum Triglycerides
研究概览
简要总结
Background and aim:
Diabetes mellitus as a chronic disease is on rise on parallel with diseases. Magnesium (Mg) supplementation may help control glycemic response among type 2 diabetes (T2D) patients. We aim to present an overview of the possible influence of drinking water in general and mineral water in particular in improving glycemic parameters in persons with type 2 diabetes.
Method:
A randomized double blind controlled clinical trial will be conducted at the Endocrine clinic (KFHU) on 900 of patients with T2DM. All subjects participated in this study will be randomly allotted into three groups (each group N=300) to which the three waters were supplied in similar bottles marked A "tap water", B "bottle water" and C "control without any intervention".
Blood samples will be taken before and after the intervention to determine the serum concentration of magnesium, Calcium, Vit D, creatinine, FBS, serum Ca, HbA1c, fasting C-peptide levels, fasting insulin levels and insulin sensitivity. Magnesium and calcium levels in urine will be expressed as the creatinine ratio
详细描述
Study population and design:
A randomized double blind controlled clinical trial will be conducted at the Endocrine clinic (KFHU) on 900 of patients with T2DM. This sample size was calculated at confidence interval of 95%. for the total diabetic outpatients in Endocrine clinic at KFHU during the period October 2020-May 2021.
All subjects living in the 3 catchment areas (Dammam. Khobar and Dhahran) in the eastern province before inclusion were selected.
Intervention All subjects participated in this study will be randomly (double-blind) allotted into three groups (each group N=300) to which the three waters were supplied in similar bottles marked A "tap water", B "Low Mg bottle water (50mg/l)" and C " high Mg bottle water (100 mg/l)". These doses have been chosen according to the guideline of WHO.
All patients will be asked to consume at least one liter of water/day. When preparing coffee and tea, ordinary tap water could be used. The intervention will be lasted for lasted 3 months. None of the participants will be changed their normal dietary habits during the trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 20 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients with type 2
- •On any diabetic treatment
- •Exclusion criteria:
- •Type 1 diabetic Delete repeated word
- •Pregnant women
- •Patients who use of immunosuppressive, corticosteroids, and non-steroidal anti-inflammatory.
- •Patients who have renal dysfunction or doing dialysis.
排除标准
- 未提供
结局指标
主要结局
Serum Triglycerides
时间窗: 3 months
Serum Triglycerides mg/dL. Baseline and 3 months
Magnesium (Mg).
时间窗: 3 months
Serum Mg mg/dL. Baseline and 3 months
HbA1c
时间窗: 3 months
HbA1c. Baseline and 3 months
Serum HDL (high-density lipoprotein)
时间窗: 3 months
Serum HDL mg/dL. Baseline and 3 months
Serum Cholesterol
时间窗: 3 months
Serum Cholesterol mg/dL. Baseline and 3 months
Serum LDL (low-density lipoprotein)
时间窗: 3 months
Serum LDL mg/dL. Baseline and 3 months
Fasting blood glucose
时间窗: 3 months
Fasting blood glucose mg/dL. Baseline and 3 months
Insulin μIU/mL
时间窗: 3 months
Serum Insulin μIU/mL. Baseline and 3 months
次要结局
- Blood Urea mg/dL(3 months)
- Urine Microalbumin(3 months)
- Serum Creatinine.(3 months)
- Serum Calcium(3 months)
- Serum Vitamin D(3 months)
研究者
MOHAMMED ALHARIRI
Principal Investigator
Imam Abdulrahman Bin Faisal University