Regulation Of Maternal Fuel Supply And Neonatal Adiposity

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2016 by University of Colorado, Denver
Sponsor:
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
University of Colorado, Denver
ClinicalTrials.gov Identifier:
NCT00826904
First received: January 21, 2009
Last updated: June 16, 2016
Last verified: June 2016
  Purpose
The purpose of this study is to determine whether unrecognized maternal hyperglycemia and postprandial lipemia early or late in gestation predicts excess neonatal adiposity.

Condition
Fetal Macrosomia
Gestational Diabetes

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Regulation Of Maternal Fuel Supply And Neonatal Adiposity

Resource links provided by NLM:


Further study details as provided by University of Colorado, Denver:

Primary Outcome Measures:
  • Change in neonatal adiposity by maternal Triglycerides, Glucose [ Time Frame: 14-16, 26-28 weeks gestation ] [ Designated as safety issue: No ]
    Prediction of neonatal adiposity by maternal Triglycerides and Glucose

  • Change in maternal postprandial lipemia [ Time Frame: 26-28 weeks gestation ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in maternal postprandial lipemia [ Time Frame: 14-16, 26-28 weeks gestation ] [ Designated as safety issue: No ]
  • Change in maternal postprandial glycemia [ Time Frame: 14-16, 26-28 weeks gestation ] [ Designated as safety issue: No ]
  • Prediction of neonatal adiposity by placental and maternal adipose tissue lipoprotein lipase (LPL) activity [ Time Frame: 26-28 weeks gestation ] [ Designated as safety issue: No ]
    adipose tissue biopsy/Neonatal adiposity by Dual x-ray Absorptiometry (DXA)

  • Correlation of neonatal adiposity and fetal growth [ Time Frame: 28-30 weeks gestation ] [ Designated as safety issue: No ]
    Neonatal adiposity by Dual-energy X-ray Absorptiometry (DXA)

  • Correlation of neonatal adiposity and fetal growth [ Time Frame: 36-37 weeks gestation ] [ Designated as safety issue: No ]
    Neonatal adiposity by Dual-energy X-ray Absorptiometry (DXA)


Estimated Enrollment: 40
Study Start Date: October 2007
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts
Lean
Healthy, pregnant women with BMI of 20 - 26 kg/m2
Obese
Healthy, obese pregnant women with BMI 30 - 38 kg/m2

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 the understanding of fetal programming is the knowledge of whether and how exposure to excess maternal fuels in the absence of frank hyperglycemia impacts fetal fat accretion. The investigators hypothesis is that neonatal adiposity results from unrecognized maternal hyperglycemia and excess lipid availability in gestation, in part caused by excessive lipolysis in the white adipose tissue of obese women, some of whom will be subsequently diagnosed as having GDM. In Aim 1 the investigators will test the hypothesis that in obese women, some of whom will later be diagnosed with GDM, increased lipolysis and unrecognized hyperglycemia and hypertriglyceridemia occur earlier in gestation than in lean women, resulting in increased plasma non-esterified fatty acids (NEFA), glycerol, triglycerides (TGs), and glucose available for fetal metabolism. In Aim 2 the investigators will test the hypothesis that fetal adiposity by ultrasound and neonatal adiposity by Dual-energy X-ray Absorptiometry (DXA) are strongly correlated with excess lipid and glucose availability in obese mothers early in gestation, regardless of GDM status, and that fasting biomarkers of neonatal insulin sensitivity will correlate with neonatal adiposity. In Aim 3 the investigators will test the hypothesis that the in-vitro suppression of lipolysis in white adipose tissue correlates with excess NEFA and TG availability in-vivo and is predictive of neonatal adiposity. The elucidation of specific derangements in both glucose and lipid metabolism and their timing in gestation in mothers who deliver infants with excess adiposity could challenge our current screening methods and entirely redirect our treatment to target the responsible maternal fuels. On a public health level, this research is instrumental to the investigators understanding of how an intrauterine environment may deliver excess glucose and/or lipids to the fetus and contribute to the genesis of the pediatric obesity epidemic. Such information may result in new treatment strategies in pregnant women to normalize fetal growth.
  Eligibility

Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-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.
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Age < 18 or > 35 yr
  • Pre-existing diabetes
  • Chronic medical conditions:

    1. hypertension,
    2. hepatitis,
    3. Human immunodeficiency Virus (HIV),
    4. Thrombophilias,
    5. History of:

      1. thromboembolism,
      2. renal disease,
      3. neurologic diseases,
      4. rheumatologic disorders,
      5. gastrointestinal disease,
      6. cardiac dysfunction, or
      7. pulmonary disease
  • Obstetric conditions:

    1. history of stillbirth,
    2. severe growth restriction,
    3. severe preeclampsia, or
    4. placental abruption
  • Medications known to affect lipid or glucose metabolism:

    1. Metformin,
    2. glucocorticoids,
    3. beta agonists or blockers, or
    4. antihypertensives
  • Use of recreational drugs, alcohol or tobacco.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00826904

Contacts
Contact: Teri L Hernandez, RN 303-724-3943 teri.hernandez@ucdenver.edu

Locations
United States, Colorado
University of Colorado Denver Recruiting
Aurora, Colorado, United States, 80045
Principal Investigator: Linda A Barbour, MD, MSPH         
Sub-Investigator: Jed Friedman, PhD         
Sub-Investigator: Wendy M Kohrt, PhD         
Sub-Investigator: Patti Thureen, MD         
Sub-Investigator: Henry Galan, MD         
Sub-Investigator: Rachael E Van Pelt, PhD         
Sub-Investigator: Teri L Hernandez, RN         
Sub-Investigator: Melanie S Reece, PhD         
Sponsors and Collaborators
University of Colorado, Denver
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
Principal Investigator: Linda A Barbour, MD, MSPH University of Colorado, Denver
  More Information

Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT00826904     History of Changes
Other Study ID Numbers: 07-0535  R56DK078645 
Study First Received: January 21, 2009
Last Updated: June 16, 2016
Health Authority: United States: Institutional Review Board

Keywords provided by University of Colorado, Denver:
Fetal programming
Fetal macrosomia
Fetal health
Gestational diabetes
Maternal health
Maternal obesity

Additional relevant MeSH terms:
Fetal Diseases
Diabetes, Gestational
Fetal Macrosomia
Pregnancy Complications
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Pregnancy in Diabetics
Diabetes Complications
Birth Weight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on August 29, 2016