| Conditions: |
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Overweight and Obesity - Insulin Resistance - Diabetes, Gestational - Hypertension in Pregnancy - Pre-Eclampsia |
| Purpose: |
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Women with excess adiposity while pregnant are more likely to develop gestational diabetes
and high blood pressure during pregnancy than women of healthy weights. This may occur
because overweight and obese pregnant women are less sensitive to insulin and have more
inflammation than pregnant women of healthy weights. This study will examine the effect of a
nutritional supplement, docosahexaenoic acid (DHA), on improving insulin sensitivity and
lessening inflammation in overweight and obese pregnant women.
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| Study Summary: |
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The effects of overweight and obesity during pregnancy on maternal and child health can be
serious and long lasting. Overweight and obese women are more likely to develop gestational
diabetes or pre-eclampsia (high blood pressure and proteinuria) during pregnancy and type 2
diabetes and cardiovascular disease after pregnancy. Also, children born to these women have
an increased risk of obesity, diabetes, and high blood pressure later in life. The increased
risk of these diseases and conditions may occur because overweight and obese pregnant women
have decreased insulin sensitivity and increased inflammation. The nutrient DHA is an
omega-3 fatty acid that is important for brain function, the development of the central
nervous system, and visual function in infants. DHA may also benefit both pregnant women and
their babies by improving insulin sensitivity and decreasing inflammation, thereby
decreasing the risk of gestational diabetes and pre-eclampsia during pregnancy. The purpose
of this study is to evaluate the effect of DHA supplementation on insulin sensitivity,
inflammation, and fetal growth in overweight and obese pregnant women.
This study will enroll women at 24 to 28 weeks of pregnancy. They will be followed until
delivery. Participants will be randomly assigned to receive either DHA supplements or
placebo on a daily basis until the end of their pregnancies. At a baseline study visit, a
blood sample will be collected; height, weight, and skinfold thickness will be measured; and
questionnaires to assess diet and medical history will be given. Participants will complete
three diet recalls in the days after the visit, in which they will answer questions about
their diet in the previous 24 hours. At a second study visit that will occur at 30 to 32
weeks of pregnancy, a blood sample will be collected. At a third study visit that will occur
at 34 to 36 weeks of pregnancy, a blood sample will be collected and repeat body
measurements will occur. Three diet recalls will then be completed, and participants will
take part in a meal challenge, in which blood will be collected at different times after
eating a study-provided breakfast. Researchers will review participants' medical records
after the birth occurs.
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| Criteria: |
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Inclusion Criteria:
- Pre-pregnant body mass index greater than 25
- Singleton pregnancy
- Speaks English
Exclusion Criteria:
- High intake of DHA foods (i.e., more than 1 fish meal per week, use of DHA-fortified
foods, or use of any supplements that contain DHA)
- Concurrent inflammatory, vascular, or metabolic disease, including diabetes,
polycystic ovary disease, collagen vascular disease, inflammatory bowel disease, or
infection
- Current or previous use of tobacco, street drugs, or medications known to affect
inflammatory markers, including corticosteroids
- Excessive weight gain or loss before pregnancy (more than 20 pounds), including
weight loss due to bariatric surgery
- Plans to leave the area during the study period
- Inability to travel to General Clinical Research Center
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| NCT ID: |
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NCT00865683 |
| Primary Contact: |
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Principal Investigator
Debra A. Krummel, PhD, RD
University of Cincinnati
Debra A. Krummel, PhD, RD
Phone: 513-558-8537
Email: debra.krummel@uc.edu
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| Backup Contact: |
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Email: margaret.andrews@uc.edu
Margaret Andrews, MD, MS, RD
Phone: 513-558-7042
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| Location Contact: |
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Cincinnati, Ohio 45229
United States
Margaret Andrews, MD, MS, RD
Phone: 513-558-7042
Email: margaret.andrews@uc.edu
Site Status: Recruiting |