Nutritional Intervention During Gestation and Offspring Health

Maternal Glycemia Clinical Trial

Official title:

NIGO Health- Nutritional Intervention During Gestation and Offspring Health

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02285764
• Other study ID #: AL10
• Status: Completed
• Phase: N/A
• Start date: December 2014
• Est. completion date: April 2018

Study information

• Verified date: June 2018
• Source: Abbott Nutrition
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 331
• Est. completion date: April 2018
• Est. primary completion date: April 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Maternal Glycemia

Intervention

Other:
• Nutritional Supplement
Modified carbohydrate
• Standard of Care
As determined by the study site

Locations

Country	Name	City	State
Germany	Ludwig-Maximilians-University of Munich, Dr. von Hauner Children's Hospital	München
Spain	University Clinical Hospital San Cecilio	Granada
Spain	University of Granda	Granada

Sponsors (2)

Lead Sponsor	Collaborator
Abbott Nutrition	European Union

Countries where clinical trial is conducted

Germany,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maternal Oral Glucose Tolerance Test (OGTT)	2 hour OGTT	27-28 weeks gestation
Secondary	Neonatal Body Composition		Birth - 72 hours
Secondary	Maternal Fasting Blood Glucose		34-36 weeks gestation