NCT02285764
Completed
Not Applicable
NIGO Health- Nutritional Intervention During Gestation and Offspring Health
ConditionsMaternal Glycemia
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Maternal Glycemia
- Sponsor
- Abbott Nutrition
- Enrollment
- 331
- Locations
- 3
- Primary Endpoint
- Maternal Oral Glucose Tolerance Test (OGTT)
- Status
- Completed
- Last Updated
- 7 years ago
Overview
Brief Summary
The purpose of this study is to investigate the potential effects of a modified carbohydrate nutritional product for obese pregnant women to reduce maternal glycemia.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Voluntarily signed and dated an ICF, approved by an IEC/IRB and provided applicable privacy authorization prior to any participation in the study.
- •Obese (BMI ≥ 30) as determined by pre-pregnancy BMI.
- •≥18 years of age.
- •≥15+0 but ≤16+6 weeks gestation with a singleton pregnancy.
- •Willing to follow supplementation protocol and follow appropriate nutritional guidance and refrain from consuming other caloric nutritional supplements that are not approved by the study staff, if applicable.
- •Willing to provide body composition measures on infant at birth.
- •Willing to consider additional measures if follow-up studies are conducted.
Exclusion Criteria
- •Adverse maternal and/or fetal medical history which is expected to alter blood glucose regulations.
- •Previously diagnosed diabetes, previous gestational diabetes, systemic lupus erythematodes, anti-phospholipid syndrome, known renal disease, treated hypertension, uncontrolled hypothyroidism and/or cancer.
- •Taking medications that can impact blood glucose.
- •Previous bariatric surgery.
- •Lactose intolerant and/or has milk protein allergy or requires a special diet regime.
- •Participating in another clinical trial that would impact participation in this study.
Outcomes
Primary Outcomes
Maternal Oral Glucose Tolerance Test (OGTT)
Time Frame: 27-28 weeks gestation
2 hour OGTT
Secondary Outcomes
- Maternal Fasting Blood Glucose(34-36 weeks gestation)
- Neonatal Body Composition(Birth - 72 hours)
Study Sites (3)
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