Status:
COMPLETED
Regulation Of Maternal Fuel Supply And Neonatal Adiposity
Lead Sponsor:
University of Colorado, Denver
Collaborating Sponsors:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions:
Fetal Macrosomia
Gestational Diabetes
Eligibility:
FEMALE
18-35 years
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.
Detailed Description
Mounting epidemiologic evidence suggests that maternal obesity and Gestational Diabetes Mellitus (GDM) independently influence size at birth and disease susceptibility later in life. A major gap in th...
Eligibility Criteria
Inclusion
- Age 18 - 35 yr
- Pregnant (12-14 weeks gestation)
- Lean (BMI 20-26 kg/m2)
- Obese (BMI 30-38 kg/m2)
Exclusion
- 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
- Obstetric conditions:
- history of stillbirth,
- severe growth restriction,
- severe preeclampsia, or
- placental abruption
- Medications known to affect lipid or glucose metabolism:
- Metformin,
- glucocorticoids,
- beta agonists or blockers, or
- antihypertensives
- Use of recreational drugs, alcohol or tobacco.
Key Trial Info
Start Date :
October 1 2007
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
March 20 2017
Estimated Enrollment :
59 Patients enrolled
Trial Details
Trial ID
NCT00826904
Start Date
October 1 2007
End Date
March 20 2017
Last Update
November 5 2019
Active Locations (1)
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1
University of Colorado Denver
Aurora, Colorado, United States, 80045