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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 is a NA study that has completed, run by Vanderbilt University Medical Center. The registered enrollment target is 39 participants.
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.
Interventions
- OTHER Dietary Intervention
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 39 participants |
| Start Date | 2019-11-18 |
| Est. Completion | 2021-06-30 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03997409
The ClinicalTrials.gov registry entry for NCT03997409 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 39 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Vanderbilt University Medical Center, which has 677 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Dietary Intervention is the first listed.
NCT03997409 reports 0 study locations.
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.
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