Clinical trial NCT04037098: Magnesium Lactate in the Reduction of Gestational Diabetes Incidence.
Official title: Efficiency and Safety of Magnesium Lactate Administration in the Reduction of Gestational Diabetes Incidence.
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Pregnancy Related
Lead sponsor: Coordinación de Investigación en Salud, Mexico
Sponsor class: OTHER_GOV
First posted: 2019-07-30
Enrollment: 0
Sex: FEMALE
Minimum age (years): 19
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: PREVENTION

Brief summary: 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: 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.

Eligibility criteria: 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)

Primary outcomes:
measure: Decreased of gestational diabetes incidence
timeFrame: Three months.
Secondary outcomes:
Other outcomes:
Locations:
city: Durango
country: Mexico
facility: Biomedical Research Unit. IMSS. Durango
state: Dgo
Study officials:
affiliation: Instituto Mexicano del Seguro Social
name: Fernando PD Guerrero
role: PRINCIPAL_INVESTIGATOR
affiliation: Instituto Mexicano del Seguro Social
name: Luis PD Simental
role: STUDY_CHAIR
affiliation: Instituto Mexicano del Seguro Social
name: Gerardo PD Martínez
role: STUDY_CHAIR
affiliation: Instituto Mexicano del Seguro Social
name: Cludia PD Gamboa
role: STUDY_CHAIR
References:
citation: Mack LR, Tomich PG. Gestational Diabetes: Diagnosis, Classification, and Clinical Care. Obstet Gynecol Clin North Am. 2017 Jun;44(2):207-217. doi: 10.1016/j.ogc.2017.02.002.
citation: Kim C. Maternal outcomes and follow-up after gestational diabetes mellitus. Diabet Med. 2014 Mar;31(3):292-301. doi: 10.1111/dme.12382.
citation: Al-Badri MR, Zantout MS, Azar ST. The role of adipokines in gestational diabetes mellitus. Ther Adv Endocrinol Metab. 2015 Jun;6(3):103-8. doi: 10.1177/2042018815577039.
citation: Fan Y, Xu R, Cai L, Cai L. [Risk factors of gestational diabetes mellitus among the re-birth pregnant women in Xiamen City in 2015-2016]. Wei Sheng Yan Jiu. 2017 Nov;46(6):925-929. Chinese.
citation: Sarrafzadegan N, Khosravi-Boroujeni H, Lotfizadeh M, Pourmogaddas A, Salehi-Abargouei A. Magnesium status and the metabolic syndrome: A systematic review and meta-analysis. Nutrition. 2016 Apr;32(4):409-17. doi: 10.1016/j.nut.2015.09.014. Epub 2015 Oct 23.
citation: Asemi Z, Karamali M, Jamilian M, Foroozanfard F, Bahmani F, Heidarzadeh Z, Benisi-Kohansal S, Surkan PJ, Esmaillzadeh A. Retracted: Magnesium supplementation affects metabolic status and pregnancy outcomes in gestational diabetes: a randomized, double-blind, placebo-controlled trial. Am J Clin Nutr. 2015 Jul;102(1):222-9. doi: 10.3945/ajcn.114.098616. Epub 2015 May 27.
citation: Han H, Fang X, Wei X, Liu Y, Jin Z, Chen Q, Fan Z, Aaseth J, Hiyoshi A, He J, Cao Y. Dose-response relationship between dietary magnesium intake, serum magnesium concentration and risk of hypertension: a systematic review and meta-analysis of prospective cohort studies. Nutr J. 2017 May 5;16(1):26. doi: 10.1186/s12937-017-0247-4.
citation: Dalton LM, Ni Fhloinn DM, Gaydadzhieva GT, Mazurkiewicz OM, Leeson H, Wright CP. Magnesium in pregnancy. Nutr Rev. 2016 Sep;74(9):549-57. doi: 10.1093/nutrit/nuw018. Epub 2016 Jul 21.
citation: Makrides M, Crosby DD, Bain E, Crowther CA. Magnesium supplementation in pregnancy. Cochrane Database Syst Rev. 2014 Apr 3;2014(4):CD000937. doi: 10.1002/14651858.CD000937.pub2.
citation: Guerrero-Romero F, Rodriguez-Moran M. [Oral magnesium supplementation: an adjuvant alternative to facing the worldwide challenge of type 2 diabetes?]. Cir Cir. 2014 May-Jun;82(3):282-9. Spanish.
citation: Morton A. Hypomagnesaemia and pregnancy. Obstet Med. 2018 Jun;11(2):67-72. doi: 10.1177/1753495X17744478. Epub 2018 Mar 7.
citation: Alves JG, de Araujo CA, Pontes IE, Guimaraes AC, Ray JG. The BRAzil MAGnesium (BRAMAG) trial: a randomized clinical trial of oral magnesium supplementation in pregnancy for the prevention of preterm birth and perinatal and maternal morbidity. BMC Pregnancy Childbirth. 2014 Jul 8;14:222. doi: 10.1186/1471-2393-14-222.
citation: Dainelli L, Prieto-Patron A, Silva-Zolezzi I, Sosa-Rubi SG, Espino Y Sosa S, Reyes-Munoz E, Lopez-Ridaura R, Detzel P. Screening and management of gestational diabetes in Mexico: results from a survey of multilocation, multi-health care institution practitioners. Diabetes Metab Syndr Obes. 2018 Apr 5;11:105-116. doi: 10.2147/DMSO.S160658. eCollection 2018.
citation: Ramirez-Torres MA. The importance of gestational diabetes beyond pregnancy. Nutr Rev. 2013 Oct;71 Suppl 1:S37-41. doi: 10.1111/nure.12070.