Nutritional Intervention During Gestation and Offspring Health

Not Applicable

Completed

• Conditions: Maternal Glycemia
• Interventions: Other: Nutritional Supplement; Other: Standard of Care

• 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

Study Timeline

• Study First Submitted: 2014-11-04
• Study First Submitted QC: 2014-11-05
• Study First Posted: 2014-11-07
• Study Start: 2014-12
• Primary Completion: 2018-04
• Study Completion: 2018-04
• Status Verified: 2018-06
• Last Update Submitted: 2018-06-29
• Last Update Posted: 2018-07-02

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

Arm && Interventions

Group	Intervention	Description
Nutritional Supplement	Nutritional Supplement	One 237 ml oral supplement consumed two times a day; Not commercially available.
Standard of Care	Standard of Care	As determined by the study site

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 Clinical Hospital San Cecilio; 🇪🇸 Granada, Spain

University of Granda; 🇪🇸 Granada, Spain