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NCT01346527 · ClinicalTrials.gov registry record
Fat Metabolism in Pregnancy and Neonatal Heart Function in Diabetes
A clinical trial, sponsored by Washington University School of Medicine.
- Completed
- Registry status
- 79
- Enrollment target
NCT01346527: Completed study, sponsored by Washington University School of Medicine.
NCT01346527 is a clinical trial that has completed, run by Washington University School of Medicine. The registered enrollment target is 79 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01346527 has completed, sponsored by Washington University School of Medicine.
- COMPLETED
- Registry status
- 79 participants
- Enrollment target
Study Summary
Background: The health of the next generation is likely programmed in the womb (i.e.in utero), and our understanding of how that programming happens will allow us to favorably influence the health of future generations. The focus of this proposal is to examine the effect of in utero programming on heart function in children born to women with type 2 diabetes (T2DM). Specifically, neonates born to diabetic women have abnormal heart structure and weaker heart function at birth, which may predispose them to long-term heart problems in childhood, adolescence and adulthood. At present, the reason for these heart abnormalities in children born to women with diabetes is unknown and is the focus of this proposal. Objective(s) and Hypothesis(es): The objectives are to examine the relationships among maternal lipid (fatty acid, triglyceride, very low density lipoprotein) metabolism and neonatal heart structure and function in diabetes and to identify clinical markers during pregnancy for heart dysfunction in infants born to diabetic women. The overall hypothesis is that maternal lipid metabolism is abnormal in diabetes, and this metabolic dysregulation increases fatty acid delivery to the fetus in utero and leads to abnormal accumulation of lipid in the fetal heart, resulting in altered neonatal heart structure and function in infants born to diabetic women. In addition, the investigators hypothesize that decreased maternal fatty acid oxidation (fat "burning") rate, elevated lipolytic (fat breakdown) rate and elevated blood total free fatty acid level predicts abnormal neonatal heart structure and function in infants born to women with type 2 diabetes. Methods and Procedures: The investigators will test these hypotheses by using clinical metabolism studies (infusion of stable isotope labeled fatty acid, serial blood and breath sampling, and mass spectrometry) to quantify whole-body fat (fatty acid oxidation, lipolysis, and serum fatty acid , triglycerides, VLDL-cholesterol
Primary Outcome
Left ventricular contractility measured by speckle tracking echocardiography
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 79 participants |
| Start Date | 2011-04 |
| Est. Completion | 2014-07 |
What the finished NCT01346527 record still lists
NCT01346527 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 79 participants, a relatively small participant target.
The record links to 0 conditions, and to 0 interventions.
NCT01346527 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01346527 about?
NCT01346527 is a clinical study titled "Fat Metabolism in Pregnancy and Neonatal Heart Function in Diabetes". Background: The health of the next generation is likely programmed in the womb (i.e.in utero), and our understanding of how that programming happens will allow us to favorably influence the health of future generations. The focus of this proposal is to examine the effect of in utero programming on h...
What is the current status of trial NCT01346527?
This trial is currently completed. The enrollment target is 79 participants. The study started on 2011-04. Estimated completion is 2014-07.
Who is sponsoring clinical trial NCT01346527?
This trial is sponsored by Washington University School of Medicine, which has 1,502 total clinical trials registered on ClinicalTrials.gov.
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