Soy Supplementation and Gestational Diabetes
Completed · Early Phase 1
Conditions studied: Gestational Diabetes
In brief
The purpose of this study is to assess the feasibility of randomizing pregnant women at high risk for gestational diabetes to a 24-week period of soy food consumption. This study will also examine the effects of soy protein and isoflavones on glucose metabolism and lipid levels among pregnant women at high risk for gestational diabetes, and on child's weight and height at birth and 6 weeks of life.
Key facts
- Study ID
- NCT02806739
- Run by
- University of Massachusetts, Boston
- People needed
- 40
- Starts
- 2013-01-01
- Expected to finish
- 2016-09-01
- Last updated by the study team
- 2016-10-27
Who can join
Age: 18 and older. Sex: female. Healthy volunteers: accepted.
You may qualify if…
- Age >=18 years
- ≤ 18 weeks of pregnancy
- Singleton pregnancy
- Have at least one of the risk factors for GDM, including overweight (BMI ≥ 25 kg/m2) before this pregnancy, first-degree relative with type-2 diabetes mellitus (T2DM), abnormal glucose tolerance/GDM in previous pregnancy, and/or history of macrosomia (birth weight ≥ 4,000 gram) in previous pregnancy
- Being able and willing to give written informed consent.
You may not qualify if…
- Allergic to soy or milk products
- Current smoker
- Preexisting diabetes outside of pregnancy or other heath conditions that could affect glucose levels
- Chronic or serious medical conditions such as hypertension, heart disease, stroke, chronic renal or hepatic disease, or malignant disease (by self-report and medical record review)
- Use of medications that could interfere with insulin secretion or insulin sensitivity
- Weight loss during this pregnancy more than 10% of pre-pregnancy body weight
- Current severe nausea and/or vomiting (by self-report).
Where it is running
- Tufts Medical Center — Boston, Massachusetts, United States
Full record on ClinicalTrials.gov
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