Efficiency and Safety of Magnesium Lactate Administration in the Reduction of Gestational Diabetes Incidence.
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 试验地点
- 1
- 主要终点
- Decreased of gestational diabetes incidence
研究概览
简要总结
Gestational diabetes, occurs during the second or third trimester of pregnancy, with no prior history of diabetes; this entity can be resolved at the end of pregnancy. Magnesium is the fourth most abundant mineral in the body, It plays an essential role in the regulation of insulin metabolism, in the functions of adenosine triphosphate. In Mexico, the prevalence of hypomagnesemia is 36.3% for women. Findings suggesting that magnesium supplementation may be a beneficial indication in metabolic glucose disorders. The hypothesis of this study is: that Magnesium lactate administration is safe and reduces the incidence of gestational diabetes.
详细描述
Objective: This study aims to evaluate the efficacy and safety of magnesium lactate oral administration in reducing the gestational diabetes incidence.
Design: Randomized, double-blind, placebo-controlled clinical trial.
Study population: Pregnant women aged 19 to 35 years, in the twelfth week of pregnancy, whit hypomagnesemia and without the concomitant disease.
Study groups: an intervention group and a control group.
Sample size: It was calculated using a statistical power of 80%, an alpha value of 0.05; 15% of the difference in the mean of gestational diabetes incidence control group and intervention groups was considered. The estimated sample size was 110 subjects for each group.
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
- Double (Participant, Care Provider)
盲法说明
Neither the patient nor the treating doctor will know the study group the participant was randomized.
入排标准
- 年龄范围
- 19 Years 至 35 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Pregnant women aged 19 to 35 years.
- •12th to 14th gestation weeks.
- •Informed consent of the participant.
排除标准
- •Diabetes.
- •High blood pressure.
- •Hypertriglyceridemia (>250 g/dL)
- •Neoplasia disease.
- •Thyroid disease.
- •Hepatic disease.
- •Consumption of alcoholic beverages.
- •Medication use (thiazide diuretics, anti-blocking agents, calcium antagonists, statins, nicotinic acid, phenytoin, valproic acid, antidepressants, beta-adrenergic, theophylline, glucocorticoids, in the last year)
研究组 & 干预措施
Magnesium
Magnesium lactate, 2 tablets orally every 12 hours (equivalent to 360 mg of elemental magnesium) for 3 months plus baseline dietary magnesium requirement.
干预措施: Magnesium lactate. (Dietary Supplement)
Control
2 tablets orally every 12 hours of on inert placebo for three months plus baseline dietary magnesium requirement.
干预措施: Placebo (Dietary Supplement)
结局指标
主要结局
Decreased of gestational diabetes incidence
时间窗: Three months.
The incidence of gestational diabetes will be considered as a decrease, at the small proportion difference of less than 13.4% between the incidence of gestational diabetes in the intervention group and the placebo group.
次要结局
未报告次要终点
研究者
Fernando Guerrero Romero MD
Head of the research unit
Coordinación de Investigación en Salud, Mexico