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Nutritional Intervention During Gestation and Offspring Health

This study is currently recruiting participants.
Verified March 2017 by Abbott Nutrition
Sponsor:
ClinicalTrials.gov Identifier:
NCT02285764
First Posted: November 7, 2014
Last Update Posted: March 30, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
European Union
Information provided by (Responsible Party):
Abbott Nutrition
  Purpose
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.

Condition Intervention
Maternal Glycemia Other: Nutritional Supplement Other: Standard of Care

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: NIGO Health- Nutritional Intervention During Gestation and Offspring Health

Resource links provided by NLM:


Further study details as provided by Abbott Nutrition:

Primary Outcome Measures:
  • Maternal Oral Glucose Tolerance Test (OGTT) [ Time Frame: 27-28 weeks gestation ]
    2 hour OGTT


Secondary Outcome Measures:
  • Neonatal Body Composition [ Time Frame: Birth - 72 hours ]
  • Maternal Fasting Blood Glucose [ Time Frame: 34-36 weeks gestation ]

Estimated Enrollment: 363
Study Start Date: November 2014
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: December 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Nutritional Supplement
One 237 ml oral supplement consumed two times a day; Not commercially available.
Other: Nutritional Supplement
Modified carbohydrate
Standard of Care
As determined by the study site
Other: Standard of Care
As determined by the study site

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02285764


Contacts
Contact: Kristen DeLuca, MS, RD 614-624-5455 kristen.deluca@abbott.com

Locations
Germany
Ludwig-Maximilians-University of Munich, Dr. von Hauner Children's Hospital Active, not recruiting
München, Germany, 80337
Spain
University of Granda Recruiting
Granada, Spain, 11 18071
Principal Investigator: Cristina Campoy, MD, PhD         
University Clinical Hospital San Cecilio Recruiting
Granada, Spain, 16 18012
Principal Investigator: Cristina Campoy, MD, PhD         
Sponsors and Collaborators
Abbott Nutrition
European Union
Investigators
Study Chair: Elena Oliveros Delgado, BSc, MSc Abbott Nutrition
Study Chair: Ricardo Rueda, MD, PhD Abbott Nutrition
  More Information

Responsible Party: Abbott Nutrition
ClinicalTrials.gov Identifier: NCT02285764     History of Changes
Other Study ID Numbers: AL10
First Submitted: November 4, 2014
First Posted: November 7, 2014
Last Update Posted: March 30, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided