Maternal Glycemia
Conditions
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.
Interventions
OTHERNutritional Supplement
Modified carbohydrate
OTHERStandard of Care
As determined by the study site
Sponsors
European Union
Abbott Nutrition
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Maternal Oral Glucose Tolerance Test (OGTT) | 27-28 weeks gestation | 2 hour OGTT |
Secondary
| Measure | Time frame |
|---|---|
| Neonatal Body Composition | Birth - 72 hours |
| Maternal Fasting Blood Glucose | 34-36 weeks gestation |
Countries
Germany, Spain
Outcome results
None listed