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NCT03997409 · ClinicalTrials.gov registry record · NA
Impact of a Low-Carbohydrate Diet in Pediatric Type 1 Diabetes
A NA study, sponsored by Vanderbilt University Medical Center.
- Completed
- Registry status
- NA
- Development phase
- 39
- Enrollment target
NCT03997409: Completed NA study, sponsored by Vanderbilt University Medical Center.
NCT03997409 is a NA study that has completed, run by Vanderbilt University Medical Center. The registered enrollment target is 39 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (97% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03997409, a NA study, has completed, sponsored by Vanderbilt University Medical Center.
- COMPLETED
- Registry status
- NA
- Development phase
- 39 participants
- Enrollment target
Study Summary
Dietary carbohydrate consumption is a key factor influencing postprandial glycemia for patients with type 1 diabetes mellitus (T1DM). Because post-prandial glucose excursions profoundly influence hemoglobin A1c (HbA1c), therapeutic approaches to mitigate post-prandial hyperglycemia are of great importance. The quantity and source of carbohydrates affect post-prandial glycemia more than any other dietary factor. These findings serve as the physiologic basis for a growing interest in carbohydrate-restricted diets in the management of T1DM despite American Diabetes Association (ADA) guidelines that discourage restricting total carbohydrate intake to less than 130 grams per day. Although case series and prospective studies suggest low-carbohydrate diets (LCD) significantly improve HbA1c for adults with T1DM, data in the pediatric T1DM population is limited. The investigators will conduct a randomized prospective pilot study evaluating glycemic control, lipidemia, and quality of life (QOL) in pediatric T1DM patients on a LCD.
Primary Outcome
HbA1c (%) change will be measured from baseline to 12 weeks
Interventions
- OTHER Dietary Intervention
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 39 participants |
| Start Date | 2019-11-18 |
| Est. Completion | 2021-06-30 |
| Phase | NA |
What the finished NCT03997409 record still lists
NCT03997409 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 39 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (97% lower).
The record links to 0 conditions, and to 1 intervention - of which Dietary Intervention is the first listed.
NCT03997409 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03997409 about?
NCT03997409 is a clinical study titled "Impact of a Low-Carbohydrate Diet in Pediatric Type 1 Diabetes". Dietary carbohydrate consumption is a key factor influencing postprandial glycemia for patients with type 1 diabetes mellitus (T1DM). Because post-prandial glucose excursions profoundly influence hemoglobin A1c (HbA1c), therapeutic approaches to mitigate post-prandial hyperglycemia are of great impo...
What is the current status of trial NCT03997409?
This trial is currently completed. It is a NA study. The enrollment target is 39 participants. The study started on 2019-11-18. Estimated completion is 2021-06-30.
What interventions are being tested in trial NCT03997409?
The interventions under investigation include: Dietary Intervention (OTHER).
Who is sponsoring clinical trial NCT03997409?
This trial is sponsored by Vanderbilt University Medical Center, which has 677 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03997409's enrollment target sits among peer trials
39 1536th of 2000 higher than 463 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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