Magnesium Lactate in the Reduction of Gestational Diabetes Incidence.

Study Overview
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Brief Summary
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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.

Detailed Description
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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. Process: All eligible participants according to inclusion and exclusion criteria, will be randomized to one of the study groups. The intervention group will receive magnesium lactate, 2 tablets orally every 12 hours (equivalent to 360 mg of elemental magnesium) for 3 months plus baseline dietary magnesium requirement; the control group will receive 2 tablets orally every 12 hours of on inert placebo for three months plus baseline dietary magnesium requirement. The blood concentrations of glucose, triglycerides, magnesium, creatinine, transaminases, and thyroid hormones will be measured, as well as the anthropometric measurements, at baseline and end conditions. Also, an oral glucose tolerance curve will be realized at the 20th gestation week. Statistical analysis: Numerical values will be expressed as mean ± standard deviation; categorical variables will be expressed as proportions. Differences between the groups were estimated by unpaired Student t-test for numerical variables (Mann-Whitney U test for skewed data) or Chi-square and Fisher´s exact test for categorical variables. Intragroup differences were estimated by paired Student t-test.

Official Title
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Efficiency and Safety of Magnesium Lactate Administration in the Reduction of Gestational Diabetes Incidence.

Conditions
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Pregnancy Related

Intervention / Treatment
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* Dietary Supplement: Magnesium lactate.
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Pregnant women aged 19 to 35 years. 12th to 14th gestation weeks. Informed consent of the participant. Exclusion Criteria: Diabetes. High blood pressure. Hypertriglyceridemia (>250 g/dL) Neoplasia disease. Thyroid disease. Hepatic disease. Consumption of alcoholic beverages. Smoking. Medication use (thiazide diuretics, anti-blocking agents, calcium antagonists, statins, nicotinic acid, phenytoin, valproic acid, antidepressants, beta-adrenergic, theophylline, glucocorticoids, in the last year)

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Study groups: Intervention group. Women 19 to 35 years of age, in the twelfth week of pregnancy, who will receive magnesium lactate, 2 tablets orally every 12 hours (equivalent to 360 mg of elemental magnesium) for 3 months plus baseline dietary magnesium requirement. Control group. Women 19 to 35 years of age, in the twelfth week of pregnancy, who will receive 2 tablets orally every 12 hours of on inert placebo for three months plus baseline dietary magnesium requirement.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Magnesium<br>Magnesium lactate, 2 tablets orally every 12 hours (equivalent to 360 mg of elemental magnesium) for 3 months plus baseline dietary magnesium requirement. | Dietary Supplement: Magnesium lactate.<br>* 2 tablets orally every 12 hours (equivalent to 360 mg of elemental magnesium) for 3 months<br>|
| Placebo Comparator: Control<br>2 tablets orally every 12 hours of on inert placebo for three months plus baseline dietary magnesium requirement. | Dietary Supplement: Placebo<br>* 2 tablets orally every 12 hours of on inert placebo for three months<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Decreased of gestational diabetes incidence | 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. | Three months. |