Status:
COMPLETED
Nutritional Intervention During Gestation and Offspring Health
Lead Sponsor:
Abbott Nutrition
Collaborating Sponsors:
European Union
Conditions:
Maternal Glycemia
Eligibility:
FEMALE
18+ years
Phase:
NA
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.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2018
Estimated Enrollment :
331 Patients enrolled
Trial Details
Trial ID
NCT02285764
Start Date
December 1 2014
End Date
April 1 2018
Last Update
July 2 2018
Active Locations (3)
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1
Ludwig-Maximilians-University of Munich, Dr. von Hauner Children's Hospital
München, Germany, 80337
2
University of Granda
Granada, Spain, 11 18071
3
University Clinical Hospital San Cecilio
Granada, Spain, 16 18012