Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT01926457 · ClinicalTrials.gov registry record · NA
Treating Prediabetes in the First Trimester
A NA study, sponsored by University of California, San Diego.
- Completed
- Registry status
- NA
- Development phase
- 202
- Enrollment target
NCT01926457 is a NA study that has completed, run by University of California, San Diego. The registered enrollment target is 202 participants.
The verdict
NCT01926457, a NA study, has completed, sponsored by University of California, San Diego.
- COMPLETED
- Registry status
- NA
- Development phase
- 202 participants
- Enrollment target
Study Summary
The investigators plan to study a sample of women with prediabetes (diagnosed by Hemoglobin A1c (HbA1c) 5.7-6.4% or fasting plasma glucose (FPG) 92-125 mg/dL) in the first trimester of pregnancy, and patients will be randomized to first trimester or third trimester treatment; the first trimester group will receive intervention immediately upon diagnosis of prediabetes whereas the third trimester group will receive only routine prenatal care until 28 weeks at which time they will receive intervention. Intervention is defined as: * diabetes education * blood glucose monitoring * medications as needed * growth ultrasounds * antenatal testing The primary outcome is umbilical cord C-Peptide \>90th percentile. Secondary outcomes include neonatal fat mass at delivery, infant weight-for-length at 12 months of age, maternal gestational weight gain, and biomarkers (chemicals) measured in the placenta and the baby's umbilical cord blood. The investigators hypothesize that women who undergo the above intervention in the first trimester will deliver significantly fewer neonates with umbilical cord C-Peptide \>90th percentile, and that the neonates will have lower fat mass, and weight-for-length at 12 months. The investigators further hypothesize that a greater proportion of patients undergoing first trimester intervention will have appropriate maternal gestational weight gain as defined by the Institute of Medicine, and a greater proportion will return to prepregnancy weight within 12 months.
Interventions
- OTHER Treatment of Prediabetes
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 202 participants |
| Start Date | 2013-07 |
| Est. Completion | 2017-06-15 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01926457
The ClinicalTrials.gov registry entry for NCT01926457 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 202 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of California, San Diego, which has 775 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Treatment of Prediabetes is the first listed.
NCT01926457 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01926457 about?
NCT01926457 is a clinical study titled "Treating Prediabetes in the First Trimester". The investigators plan to study a sample of women with prediabetes (diagnosed by Hemoglobin A1c (HbA1c) 5.7-6.4% or fasting plasma glucose (FPG) 92-125 mg/dL) in the first trimester of pregnancy, and patients will be randomized to first trimester or third trimester treatment; the first trimester gro...
What is the current status of trial NCT01926457?
This trial is currently completed. It is a NA study. The enrollment target is 202 participants. The study started on 2013-07. Estimated completion is 2017-06-15.
What interventions are being tested in trial NCT01926457?
The interventions under investigation include: Treatment of Prediabetes (OTHER).
Who is sponsoring clinical trial NCT01926457?
This trial is sponsored by University of California, San Diego, which has 775 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.