NCT00826904

Brief Summary

The purpose of this study is to determine whether unrecognized maternal hyperglycemia and postprandial lipemia early or late in gestation predicts excess neonatal adiposity.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
59

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Oct 2007

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2007

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

January 21, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 22, 2009

Completed
8.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 20, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 20, 2017

Completed
Last Updated

November 5, 2019

Status Verified

October 1, 2019

Enrollment Period

9.5 years

First QC Date

January 21, 2009

Last Update Submit

October 31, 2019

Conditions

Fetal MacrosomiaGestational Diabetes

Keywords

Fetal programmingFetal macrosomiaFetal healthGestational diabetesMaternal healthMaternal obesity

Outcome Measures

Primary Outcomes (2)

  • Change in neonatal adiposity by maternal Triglycerides, Glucose

    Prediction of neonatal adiposity by maternal Triglycerides and Glucose

    14-16, 26-28 weeks gestation

  • Change in maternal postprandial lipemia

    26-28 weeks gestation

Secondary Outcomes (5)

  • Change in maternal postprandial lipemia

    14-16, 26-28 weeks gestation

  • Change in maternal postprandial glycemia

    14-16, 26-28 weeks gestation

  • Prediction of neonatal adiposity by placental and maternal adipose tissue lipoprotein lipase (LPL) activity

    26-28 weeks gestation

  • Correlation of neonatal adiposity and fetal growth

    28-30 weeks gestation

  • Correlation of neonatal adiposity and fetal growth

    36-37 weeks gestation

Study Arms (2)

Lean

Healthy, pregnant women with BMI of 20 - 26 kg/m2

Obese

Healthy, obese pregnant women with BMI 30 - 38 kg/m2

Eligibility Criteria

Age18 Years - 35 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Lean (BMI 20-26 kg/m2)and Obese (BMI 30-38 kg/m2) pregnant women (age 18-35 yr) without chronic medical conditions or obstetric complications will be enrolled at 12-14 weeks gestation.

You may qualify if:

  • Age 18 - 35 yr
  • Pregnant (12-14 weeks gestation)
  • Lean (BMI 20-26 kg/m2)
  • Obese (BMI 30-38 kg/m2)

You may not qualify if:

  • Age \< 18 or \> 35 yr
  • Pre-existing diabetes
  • Chronic medical conditions:
  • hypertension,
  • hepatitis,
  • Human immunodeficiency Virus (HIV),
  • Thrombophilias,
  • History of:
  • thromboembolism,
  • renal disease,
  • neurologic diseases,
  • rheumatologic disorders,
  • gastrointestinal disease,
  • cardiac dysfunction, or
  • pulmonary disease
  • +11 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Colorado Denver

Aurora, Colorado, 80045, United States

Location

Related Publications (1)

  • Barbour LA, Farabi SS, Friedman JE, Hirsch NM, Reece MS, Van Pelt RE, Hernandez TL. Postprandial Triglycerides Predict Newborn Fat More Strongly than Glucose in Women with Obesity in Early Pregnancy. Obesity (Silver Spring). 2018 Aug;26(8):1347-1356. doi: 10.1002/oby.22246. Epub 2018 Jun 22.

    PMID: 29931812DERIVED

MeSH Terms

Conditions

Fetal MacrosomiaDiabetes, GestationalPregnancy in Obesity

Condition Hierarchy (Ancestors)

Pregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesFetal DiseasesPregnancy in DiabeticsCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesDiabetes ComplicationsDiabetes MellitusEndocrine System DiseasesBirth WeightBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesObesityOverweightOvernutritionNutrition Disorders

Study Officials

  • Linda A Barbour, MD, MSPH

    University of Colorado, Denver

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 21, 2009

First Posted

January 22, 2009

Study Start

October 1, 2007

Primary Completion

March 20, 2017

Study Completion

March 20, 2017

Last Updated

November 5, 2019

Record last verified: 2019-10

Data Sharing

IPD Sharing
Will not share

Locations

US(1)