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NCT04219709 · ClinicalTrials.gov registry record · NA

Effects of Ketosis on Brain Function in Patients With T1DM

A NA study of Type 1 Diabetes, sponsored by Boston Children's Hospital.

Recruiting
Registry status
NA
Development phase
24
Enrollment target
1
Study location

NCT04219709: Recruiting NA study of Type 1 Diabetes, sponsored by Boston Children's Hospital.

NCT04219709 is a NA study of Type 1 Diabetes that is actively recruiting participants, run by Boston Children's Hospital. The registered enrollment target is 24 participants, below the 767-participant average among 198 other Type 1 Diabetes trials with a reported enrollment target (97% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04219709, a NA study of Type 1 Diabetes, 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.

Primary Outcome

The blood glucose level at which hypothalamic activation is detected by continuous BOLD functional MRI during a 40 min glycemic descent from 90 to 50 mg/dL

Conditions Studied

Interventions

  • OTHER Very low carbohydrate diet
  • OTHER Standard carbohydrate diet

Study Locations (1)

Massachusetts

  • Boston Childrens Hospital - Boston

Trial Details

FieldValue
Enrollment Target 24 participants
Start Date 2020-01-03
Est. Completion 2026-07-31
Phase NA
Boston Children's Hospital

462 total trials

What NCT04219709 shows while recruiting

NCT04219709 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 24 participants, a relatively small participant target, below the 767-participant average among 198 other Type 1 Diabetes trials with a reported enrollment target (97% lower).

The record links to 1 condition, with Type 1 Diabetes appearing as the primary indexed condition, and to 2 interventions - of which Very low carbohydrate diet is the first listed.

NCT04219709 reports a single indexed study location in 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: Type 1 Diabetes.

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.

Similar trials for Type 1 Diabetes

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT04219709's enrollment target sits among peer trials

24 141st of 198 higher than 51 of 198 other Type 1 Diabetes trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Type 1 Diabetes 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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Source: ClinicalTrials.gov NCT04219709, the US trial registry maintained by the National Library of Medicine. NCT04219709 (small enrollment · single site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.