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| Sponsors and Collaborators: |
National Heart, Lung, and Blood Institute (NHLBI) Office of Women’s Health Mead Johnson Martek Biosciences Corporation |
|---|---|
| Information provided by: | National Heart, Lung, and Blood Institute (NHLBI) |
| ClinicalTrials.gov Identifier: | NCT00865683 |
Purpose
Obese pregnant women are more likely to develop gestational diabetes and high blood pressure during pregnancy than women of healthy weights. One reason why this may occur is that obese pregnant women are less sensitive to insulin than pregnant women of healthy weights. This study will examine the effect of a nutritional supplement, docosahexaenoic acid (DHA), on improving insulin sensitivity in obese pregnant women.
| Condition | Intervention | Phase |
|---|---|---|
|
Obesity Insulin Resistance Diabetes, Gestational Pre-Eclampsia |
Dietary Supplement: DHA Supplements Dietary Supplement: Placebo Supplements |
Phase I |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment |
| Official Title: | DHA, Inflammation, and Insulin Sensitivity |
| Estimated Enrollment: | 90 |
| Study Start Date: | March 2009 |
| Estimated Study Completion Date: | April 2011 |
| Estimated Primary Completion Date: | April 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1: Active Comparator
Participants will receive DHA supplements.
|
Dietary Supplement: DHA Supplements
Participants will receive 800 mg of DHA each day for approximately 3 months (until they give birth).
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2: Placebo Comparator
Participants will receive placebo capsules.
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Dietary Supplement: Placebo Supplements
Participants will receive placebo supplements each day for approximately 3 months (until they give birth).
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The effects of obesity during pregnancy on maternal and child health can be serious and long lasting. Obese women are more likely to develop gestational diabetes or pre-eclampsia (high blood pressure) during pregnancy and type 2 diabetes and cardiovascular disease after pregnancy. Also, children born to obese women have an increased risk of obesity, diabetes, and high blood pressure. The increased risk of these diseases and conditions may occur because obese pregnant women have decreased insulin sensitivity. 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, 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, placental nutrient transport, and fetal growth in 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. At the time of delivery, study researchers will collect and analyze participants' placentas and an umbilical cord blood sample. Researchers will also review participants' medical records after the birth occurs.
Eligibility| Ages Eligible for Study: | 18 Years to 40 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Debra A. Krummel, PhD, RD | 513-558-8537 | debra.krummel@uc.edu |
| Contact: Margaret Andrews, MD, MS, RD | 513-558-7042 | margaret.andrews@uc.edu |
| United States, Ohio | |
| General Clinical Research Center | Recruiting |
| Cincinnati, Ohio, United States, 45229-3039 | |
| Contact: Margaret Andrews, MD, MS, RD 513-558-7042 margaret.andrews@uc.edu | |
| Contact: Anu Gundamaraju, BS 513-558-7041 gundamaa@email.uc.edu | |
| Principal Investigator: Debra A. Krummel, PhD, RD | |
| Principal Investigator: | Debra A. Krummel, PhD, RD | University of Cincinnati |
More Information
| Responsible Party: | University of Cincinnati ( Debra A. Krummel, PhD, RD and Theresa Powell, PhD ) |
| Study ID Numbers: | 618, HL093532-01 |
| Study First Received: | March 17, 2009 |
| Last Updated: | March 17, 2009 |
| ClinicalTrials.gov Identifier: | NCT00865683 History of Changes |
| Health Authority: | United States: Federal Government |
|
Gestational Diabetes Pregnancy Docosahexaenoic Acid DHA Maternal-Fetal Exchange |
|
Obesity Pregnancy Complications Metabolic Diseases Eclampsia Diabetes Mellitus Endocrine System Diseases Pre-Eclampsia Overweight Diabetes, Gestational Preeclampsia Insulin Inflammation |
Body Weight Signs and Symptoms Hyperinsulinism Hypertension, Pregnancy-Induced Nutrition Disorders Overnutrition Endocrinopathy Insulin Resistance Glucose Metabolism Disorders Metabolic Disorder Hypertension |
|
Obesity Pregnancy Complications Metabolic Diseases Eclampsia Diabetes Mellitus Endocrine System Diseases Pre-Eclampsia Diabetes, Gestational Overweight |
Body Weight Signs and Symptoms Hyperinsulinism Hypertension, Pregnancy-Induced Nutrition Disorders Overnutrition Insulin Resistance Glucose Metabolism Disorders |
