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NCT04219709 · ClinicalTrials.gov registry record · NA
Effects of Ketosis on Brain Function in Patients With T1DM
A NA study of Type1diabetes, sponsored by Boston Children's Hospital.
- Recruiting
- Registry status
- NA
- Development phase
- 24
- Enrollment target
- 1
- Study location
NCT04219709 is a NA study of Type1diabetes that is actively recruiting participants, run by Boston Children's Hospital. The registered enrollment target is 24 participants, below the 260-participant average among 19 other Type1diabetes trials with a reported enrollment target (91% lower). The trial reports 1 study location across 1 state.
The verdict
NCT04219709, a NA study of Type1diabetes, is actively recruiting participants, sponsored by Boston Children's Hospital.
- RECRUITING
- Registry status
- NA
- Development phase
- 24 participants
- Enrollment target
- 1
- Study location
Study Summary
The scientific goal of this study is to examine the effects of a ketogenic diet on hypoglycemia tolerance and brain function in people with type 1 diabetes mellitus (T1D) and to clarify the mechanistic role of ketones in this process. Glycemic management of T1D is typified by alternating periods of hyper- and hypo-glycemia. Because brain metabolism under usual conditions depends on glucose, acute hypoglycemia leads to immediate complications including impaired cognitive function and a counter-regulatory hormone response. Recurrent hypoglycemia is associated with functional and structural changes in the brain and contributes to the cognitive decline observed in individuals with diabetes. The state of nutritional ketosis (as it occurs during fasting or when following a ketogenic \[very low carbohydrate\] diet) may protect against these acute and chronic complications. As the body relies on fat metabolism, ketone bodies build up and provide an alternative fuel for the brain. Studies during hypoglycemia have shown better cognitive function and less hypoglycemia symptoms in the setting of nutritional ketosis or with ketone administration. This physiological benefit may have special relevance for people with T1D who experience hypoglycemia frequently. To date, no mechanistic studies have examined brain effects of nutritional ketosis in T1D; nor have any trials explored the potential relevance of this for diabetes care.
Conditions Studied
Interventions
- OTHER Very low carbohydrate diet
- OTHER Standard carbohydrate diet
Study Locations (1)
Massachusetts
- Boston Childrens Hospital - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2020-01-03 |
| Est. Completion | 2026-07-31 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04219709
The ClinicalTrials.gov registry entry for NCT04219709 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 24 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 260-participant average among 19 other Type1diabetes trials with a reported enrollment target (91% 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 Type1diabetes appearing as the primary indexed condition, and to 2 interventions - of which Very low carbohydrate diet is the first listed.
NCT04219709 reports 1 study location spanning 1 distinct geographic area - top geographies include Massachusetts.
Frequently Asked Questions
What is clinical trial NCT04219709 about?
NCT04219709 is a clinical study titled "Effects of Ketosis on Brain Function in Patients With T1DM". The scientific goal of this study is to examine the effects of a ketogenic diet on hypoglycemia tolerance and brain function in people with type 1 diabetes mellitus (T1D) and to clarify the mechanistic role of ketones in this process. Glycemic management of T1D is typified by alternating periods of ...
What is the current status of trial NCT04219709?
This trial is currently recruiting. It is a NA study. The enrollment target is 24 participants. The study started on 2020-01-03. Estimated completion is 2026-07-31.
What conditions does trial NCT04219709 study?
This clinical trial studies the following conditions: Type1diabetes.
What interventions are being tested in trial NCT04219709?
The interventions under investigation include: Very low carbohydrate diet (OTHER), Standard carbohydrate diet (OTHER).
Who is sponsoring clinical trial NCT04219709?
This trial is sponsored by Boston Children's Hospital, which has 462 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04219709 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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