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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 is a NA study that has completed, run by Nemours Children's Clinic. The registered enrollment target is 16 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03862521
The ClinicalTrials.gov registry entry for NCT03862521 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 16 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Nemours Children's Clinic, which has 108 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Very low carbohydrate diet is the first listed.
NCT03862521 reports 0 study locations.
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.
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