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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: Completed NA study, sponsored by University of California, San Diego.
NCT01926457 is a NA study that has completed, run by University of California, San Diego. The registered enrollment target is 202 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (86% lower). According to ClinicalTrials.gov, the official US trial registry.
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 |
What the finished NCT01926457 record still lists
NCT01926457 is an interventional study that assigns participants to a tested intervention. The registered 202 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (86% lower).
The record links to 0 conditions, and to 1 intervention - of which Treatment of Prediabetes is the first listed.
NCT01926457 does not publish any study locations in the registry export this page uses.
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
How this trial's enrollment target compares
Where NCT01926457's enrollment target sits among peer trials
202 505th of 2000 higher than 1,495 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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