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NCT05899166 · ClinicalTrials.gov registry record · NA
Carbohydrate Beta Cell Function and Glucose Control in Children With Diabetes
A NA study of Diabetes Mellitus, Type 1, sponsored by Boston Children's Hospital.
- Recruiting
- Registry status
- NA
- Development phase
- 52
- Enrollment target
- 1
- Study location
NCT05899166 is a NA study of Diabetes Mellitus, Type 1 that is actively recruiting participants, run by Boston Children's Hospital. The registered enrollment target is 52 participants, below the 1,266-participant average among 118 other Diabetes Mellitus, Type 1 trials with a reported enrollment target (96% lower). The trial reports 1 study location across 1 state.
The verdict
NCT05899166, a NA study of Diabetes Mellitus, Type 1, is actively recruiting participants, sponsored by Boston Children's Hospital.
- RECRUITING
- Registry status
- NA
- Development phase
- 52 participants
- Enrollment target
- 1
- Study location
Study Summary
The goal of this clinical trial is to test the effects of a ketogenic diet on the progression and control of type 1 diabetes in children with newly diagnosed diabetes. The main questions to answer are: * Does a ketogenic diet prolong the honeymoon period of type 1 diabetes? * Does a ketogenic diet improve diabetes control? * Is a ketogenic diet safe, acceptable and sustainable in children with newly diagnosed diabetes? * What are the microbiome, inflammatory and metabolic changes linking diet to β-cell function? Participants will receive a combination of free meals, groceries, micronutrient supplements, and intensive diet and diabetes education for 9 months. * Diabetes care devices will be connected for cloud-based data collection. * Bi-weekly data downloads and remote check-ins will assess dietary intake, satisfaction with diet and study procedures, and possible safety concerns. * During four study visits held at at baseline, 1, 5, and 9 months, an intravenous catheter (IV) will be placed for collection of 5 blood samples before and up to 2 hours after a liquid test meal (protein shake) to assess insulin response. A stool sample will also be collected to assess microbiome changes. * Children and their caregivers may be invited to participate in a semi-structured interview, and online questionnaires to assess their experience with the diet and diabetes care, general well-being and quality of life. * Children and their caregivers may be invited to participate in a follow-up visit to evaluate long-term effects after 24 months. Comparison will be made between a ketogenic vs standard diet.
Conditions Studied
Interventions
- OTHER Ketogenic diet, food delivery and education
- OTHER Standard diet, food delivery and education
Study Locations (1)
Massachusetts
- Boston Children's Hospital - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 52 participants |
| Start Date | 2024-05-31 |
| Est. Completion | 2029-04-30 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05899166
The ClinicalTrials.gov registry entry for NCT05899166 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 52 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,266-participant average among 118 other Diabetes Mellitus, Type 1 trials with a reported enrollment target (96% lower). The listed sponsor is Boston Children's Hospital, which has 462 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Diabetes Mellitus, Type 1 appearing as the primary indexed condition, and to 2 interventions - of which Ketogenic diet, food delivery and education is the first listed.
NCT05899166 reports 1 study location spanning 1 distinct geographic area - top geographies include Massachusetts.
Frequently Asked Questions
What is clinical trial NCT05899166 about?
NCT05899166 is a clinical study titled "Carbohydrate Beta Cell Function and Glucose Control in Children With Diabetes". The goal of this clinical trial is to test the effects of a ketogenic diet on the progression and control of type 1 diabetes in children with newly diagnosed diabetes. The main questions to answer are: * Does a ketogenic diet prolong the honeymoon period of type 1 diabetes? * Does a ketogenic diet ...
What is the current status of trial NCT05899166?
This trial is currently recruiting. It is a NA study. The enrollment target is 52 participants. The study started on 2024-05-31. Estimated completion is 2029-04-30.
What conditions does trial NCT05899166 study?
This clinical trial studies the following conditions: Diabetes Mellitus, Type 1.
What interventions are being tested in trial NCT05899166?
The interventions under investigation include: Ketogenic diet, food delivery and education (OTHER), Standard diet, food delivery and education (OTHER).
Who is sponsoring clinical trial NCT05899166?
This trial is sponsored by Boston Children's Hospital, which has 462 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05899166 being conducted?
This trial has 1 study location across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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