Evaluation of the Effects of Oral Magnesium Supplementation on Glycemic Control and Inflammation Among Patients With Type 2 Diabetes
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Inflammation
研究概览
简要总结
A total of 74 Adult Patients with type 2 diabetes mellitus (T2D) will be enrolled and randomized into 2 groups. The intervention group will receive oral magnesium (Mg) supplementation. The study objectives are:
- To estimate level of Mg (total and ionized) in patient with type 2 DM.
- To determine the effect of Mg supplementation for diabetic patient on serum Mg level, glycemic control and level of inflammation.
- To assess the correlation between serum Mg level and glycemic control and level of inflammatory mediators (CRP)
详细描述
A total of 74 Adult Patients of both genders who had been diagnosed with T2D and are on oral anti-hyperglycemic drug and their HbA1C between 7and 8 %, will be enrolled in the study. Initially the study protocol will be explained & informed written consent will be obtained from all participants. All subjects will be evaluated to ensure that they meet the eligibility criteria through: Full history taking, complete physical examination and investigations. the intervention group will receive oral magnesium (Mg) supplementation for 3 months (250 mg of elemental magnesium daily). The primary outcome is to determine the effect of Mg supplementation for diabetic patient on serum Mg level, glycemic control and level of inflammation.
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 (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with type 2 diabetes with HbA1C between 7 and 8%.
- •Both genders will be included in this study.
排除标准
- •Patients on insulin.
- •Patients on diuretics or angiotensin-converting enzyme inhibitors in the last 2 weeks.
- •Patients taking Mg containing supplements within 3 months.
- •Patients with significant gastrointestinal disorders (eg, chronic diarrhea).
- •Patients with impaired renal functions (eGFR< 60 mL/min).
- •Heart block or heart failure
- •Patients treated with aldosterone antagonists.
- •Pregnant patients
- •Patients with evidence of infection.
- •Patients with chronic inflammatory conditions eg, SLE
结局指标
主要结局
Inflammation
时间窗: 3 months
To determine the effect of oral Mg supplementation for diabetic patient on inflammation (CRP)
Glycemic control
时间窗: 3 months
To determine the effect of oral Mg supplementation for diabetic patient on Glycemic control
次要结局
- Total or ionized Mg(3 months)
- Serum magnesium level(3 months)
- Prevalence of hypomagnesemia(up to 4 weeks)
- Correlation of serum Mg level(up to 4 weeks)
研究者
Samar Fares, MD
Lecturer of family medicine
Cairo University