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NCT03862521 · ClinicalTrials.gov registry record · NA
Safety of Low and Very Low Carbohydrate Diets in Young Children With Type 1 Diabetes
A NA study, sponsored by Nemours Children's Clinic.
- Completed
- Registry status
- NA
- Development phase
- 16
- Enrollment target
NCT03862521: Completed NA study, sponsored by Nemours Children's Clinic.
NCT03862521 is a NA study that has completed, run by Nemours Children's Clinic. The registered enrollment target is 16 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03862521, a NA study, has completed, sponsored by Nemours Children's Clinic.
- COMPLETED
- Registry status
- NA
- Development phase
- 16 participants
- Enrollment target
Study Summary
The purpose of the study is to evaluate the safety of short-term (6 month) low or very-low carbohydrate diets in prepubertal children 2 to \<12 years old with type 1 diabetes. Participants will be randomized to either low carbohydrate diet (carbohydrate makes up 30-39% of total daily calories) or very-low carbohydrate diet (carbohydrates are 20-29% of total daily calories). The investigators will evaluate metabolic effects of these diets by measuring the counter-regulatory hormone response to hypoglycemia at baseline and again at 3 months. Other outcomes include diabetes control as measured by HbA1c, growth and weight gain, lipid profiles, and body composition.
Primary Outcome
Change from baseline to 3 months in the hormone (epinephrine, norepinephrine, glucagon) response to insulin-induced hypoglycemia.
Interventions
- OTHER Very low carbohydrate diet
- OTHER Low carbohydrate diet
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 16 participants |
| Start Date | 2018-08-01 |
| Est. Completion | 2022-02-28 |
| Phase | NA |
What the finished NCT03862521 record still lists
NCT03862521 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 16 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower).
The record links to 0 conditions, and to 2 interventions - of which Very low carbohydrate diet is the first listed.
NCT03862521 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03862521 about?
NCT03862521 is a clinical study titled "Safety of Low and Very Low Carbohydrate Diets in Young Children With Type 1 Diabetes". The purpose of the study is to evaluate the safety of short-term (6 month) low or very-low carbohydrate diets in prepubertal children 2 to \<12 years old with type 1 diabetes. Participants will be randomized to either low carbohydrate diet (carbohydrate makes up 30-39% of total daily calories) or ve...
What is the current status of trial NCT03862521?
This trial is currently completed. It is a NA study. The enrollment target is 16 participants. The study started on 2018-08-01. Estimated completion is 2022-02-28.
What interventions are being tested in trial NCT03862521?
The interventions under investigation include: Very low carbohydrate diet (OTHER), Low carbohydrate diet (OTHER).
Who is sponsoring clinical trial NCT03862521?
This trial is sponsored by Nemours Children's Clinic, which has 108 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03862521's enrollment target sits among peer trials
16 1871st of 2000 higher than 120 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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