Magnesium Lactate in the Reduction of Gestational Diabetes Incidence.

NCT04037098 | Withdrawn

• 1 other identifier: R-2019-785-040
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Pregnancy Related

Outcome Measures

Primary Outcomes (1)

• 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.

Study Arms (2)

Magnesium

EXPERIMENTAL

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.

Control

PLACEBO COMPARATOR

2 tablets orally every 12 hours of on inert placebo for three months plus baseline dietary magnesium requirement.

Dietary Supplement: Placebo

Interventions

Magnesium lactate. DIETARY_SUPPLEMENT

2 tablets orally every 12 hours (equivalent to 360 mg of elemental magnesium) for 3 months

Magnesium

Placebo DIETARY_SUPPLEMENT

2 tablets orally every 12 hours of on inert placebo for three months

Control

Eligibility Criteria

• Age: 19 Years - 35 Years
• Gender Eligibility Details: Pregnant women
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Pregnant women aged 19 to 35 years.
• th to 14th gestation weeks.
• Informed consent of the participant.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Coordinación de Investigación en Salud, Mexico: lead

Study Sites (1)

Biomedical Research Unit. IMSS. Durango

Durango, Durango, 34067, Mexico

Location

Related Publications (14)

• 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.

  PMID: 28499531 BACKGROUND

• Kim C. Maternal outcomes and follow-up after gestational diabetes mellitus. Diabet Med. 2014 Mar;31(3):292-301. doi: 10.1111/dme.12382.

  PMID: 24341443 BACKGROUND

• 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.

  PMID: 26137214 BACKGROUND

• 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.

  PMID: 29903201 BACKGROUND

• 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.

  PMID: 26919891 BACKGROUND

• 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.

  PMID: 26016859 BACKGROUND

• 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.

  PMID: 28476161 BACKGROUND

• 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.

  PMID: 27445320 BACKGROUND

• 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.

  PMID: 24696187 BACKGROUND

• 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.

  PMID: 25238470 BACKGROUND

• Morton A. Hypomagnesaemia and pregnancy. Obstet Med. 2018 Jun;11(2):67-72. doi: 10.1177/1753495X17744478. Epub 2018 Mar 7.

  PMID: 29997688 BACKGROUND

• 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.

  PMID: 25005784 BACKGROUND

• 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.

  PMID: 29670384 BACKGROUND

• Ramirez-Torres MA. The importance of gestational diabetes beyond pregnancy. Nutr Rev. 2013 Oct;71 Suppl 1:S37-41. doi: 10.1111/nure.12070.

  PMID: 24147923 BACKGROUND

Study Officials

• Fernando PD Guerrero

  Instituto Mexicano del Seguro Social

  PRINCIPAL INVESTIGATOR

• Luis PD Simental

  Instituto Mexicano del Seguro Social

  STUDY CHAIR

• Gerardo PD Martínez

  Instituto Mexicano del Seguro Social

  STUDY CHAIR

• Cludia PD Gamboa

  Instituto Mexicano del Seguro Social

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: Neither the patient nor the treating doctor will know the study group the participant was randomized.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of the research unit

Model Details: 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.

Study Record Dates

• First Submitted: July 26, 2019
• First Posted: July 30, 2019
• Study Start: July 31, 2022
• Primary Completion: July 31, 2022
• Study Completion: September 1, 2023
• Last Updated: September 28, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1)