Nutritional Intervention During Gestation and Offspring Health
Not Applicable
Completed
- Conditions
- Maternal Glycemia
- Registration Number
- NCT02285764
- Lead Sponsor
- Abbott Nutrition
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 331
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Maternal Oral Glucose Tolerance Test (OGTT) 27-28 weeks gestation 2 hour OGTT
- Secondary Outcome Measures
Name Time Method Maternal Fasting Blood Glucose 34-36 weeks gestation Neonatal Body Composition Birth - 72 hours
Trial Locations
- Locations (3)
Ludwig-Maximilians-University of Munich, Dr. von Hauner Children's Hospital
🇩🇪München, Germany
University of Granda
🇪🇸Granada, Spain
University Clinical Hospital San Cecilio
🇪🇸Granada, Spain
Ludwig-Maximilians-University of Munich, Dr. von Hauner Children's Hospital🇩🇪München, Germany