Magnesium Supplementation in the Second Trimester of Pregnancy to Overweight and Obese Individuals
Status: | Completed |
---|---|
Conditions: | Obesity Weight Loss |
Therapuetic Areas: | Endocrinology |
Healthy: | No |
Age Range: | Any |
Updated: | 11/18/2012 |
Start Date: | January 2012 |
End Date: | June 2013 |
Contact: | Michele J Cho, MD |
Email: | michele.cho@gmail.com |
Phone: | 212-810-9807 |
Magnesium Supplementation in the Second Trimester of Pregnancy for Overweight Individuals
This is a prospective, randomized, placebo controlled study with three parallel arms
examining the effects of magnesium supplementation in the second trimester of pregnancy.
Recent research has shown that supplemental magnesium can have beneficial effects,
especially in overweight individuals. Not only do many people have a magnesium deficient
diet, there is also evidence that magnesium can improve blood sugar levels. Due to the
growing concern of obesity with pregnancy and its associated complications, such as diabetes
and abnormal fetal growth, magnesium therapy could have novel and beneficial effects on
pregnancy outcomes.
In this study, 60 overweight and obese pregnant patients in their first trimester will be
enrolled and randomized. The first group (A) will receive oral magnesium citrate (300mg
elemental Magnesium), group B will receive dietary counseling about following a magnesium
rich diet from a nutritionist, and group C will receive a placebo (control). Blood and urine
specimens will be collected at three time points during the pregnancy to analyze changes in
levels of metabolic markers, inflammatory markers, and protein expression profiles. Fetal
and maternal complications of pregnancy will be noted, including maternal weight gain. At
delivery, patients will have a placental cord blood specimen and placental biopsy collected
for gene expression patterns and further analysis.
Inclusion Criteria:
- Between 18 and 40 years of age
- Pregnant in the first trimester
- Able to give informed consent
- Planning to deliver at UCLA
- BMI greater than or equal to 25
Exclusion Criteria:
- On insulin therapy or other oral hypoglycemic agents
- Multiple gestation
- Baseline HgbA1C > 6.5%
- Prior history of clinically diagnosed T2D
- Multiple dietary restrictions/food allergies
- Heart, renal, or liver failure
- Clinical history of psychiatric illness or substance abuse
- Out of town travel planned at study visits
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