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NCT04228822 · ClinicalTrials.gov registry record · NA

Safety and Feasibility of a Low Carbohydrate Diet in Children With Type 1 Diabetes

A NA study of Type 1 Diabetes, sponsored by Washington University School of Medicine.

Completed
Registry status
NA
Development phase
8
Enrollment target
1
Study location

NCT04228822 is a NA study of Type 1 Diabetes that has completed, run by Washington University School of Medicine. The registered enrollment target is 8 participants, below the 824-participant average among 178 other Type 1 Diabetes trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT04228822, a NA study of Type 1 Diabetes, has completed, sponsored by Washington University School of Medicine.

COMPLETED
Registry status
NA
Development phase
8 participants
Enrollment target
1
Study location

Study Summary

Good glycemic control in individuals with Type 1 diabetes (T1D), has been proven to reduce the risk of diabetes-related complications. Despite technological advances such as the use of insulin delivery devices and continuous glucose monitoring, the average glycemic control in T1D is poor. Though dietary management plays a major role in the overall management of T1D, and it is often classified as the most challenging aspect of treatment, the 2019 Standards of Medical Care in Diabetes for children and adolescents do not clearly address dietary management. As carbohydrate is the macronutrient with the greatest impact on blood glucose, it is reasonable to suggest that carbohydrate reduction will minimize postprandial glucose excursions and improve diabetes control. For this reason, low carbohydrate diets (LCD) have gained popularity, and observational studies report positive glycemic outcomes. However, to date, scientific evidence from randomized trials on the impact of LCD in children with T1D is lacking. Thus, the over-arching goal of this pilot study is to evaluate the feasibility and safety of a low carbohydrate diet in children with T1D, and as an exploratory aim, we will evaluate the efficacy of LCD on glycemic control.

Conditions Studied

Interventions

  • OTHER Low carbohydrate diet

Study Locations (1)

Missouri

  • St Louis Children's Hospital - St Louis

Trial Details

FieldValue
Enrollment Target 8 participants
Start Date 2020-11-10
Est. Completion 2022-02-28
Phase NA

What the Registry Record Tells You About NCT04228822

The ClinicalTrials.gov registry entry for NCT04228822 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 8 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 824-participant average among 178 other Type 1 Diabetes trials with a reported enrollment target (99% lower). The listed sponsor is Washington University School of Medicine, which has 1,502 total studies on file at ClinicalTrials.gov.

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

NCT04228822 reports 1 study location spanning 1 distinct geographic area - top geographies include Missouri.

Frequently Asked Questions

What is clinical trial NCT04228822 about?

NCT04228822 is a clinical study titled "Safety and Feasibility of a Low Carbohydrate Diet in Children With Type 1 Diabetes". Good glycemic control in individuals with Type 1 diabetes (T1D), has been proven to reduce the risk of diabetes-related complications. Despite technological advances such as the use of insulin delivery devices and continuous glucose monitoring, the average glycemic control in T1D is poor. Though die...

What is the current status of trial NCT04228822?

This trial is currently completed. It is a NA study. The enrollment target is 8 participants. The study started on 2020-11-10. Estimated completion is 2022-02-28.

What conditions does trial NCT04228822 study?

This clinical trial studies the following conditions: Type 1 Diabetes.

What interventions are being tested in trial NCT04228822?

The interventions under investigation include: Low carbohydrate diet (OTHER).

Who is sponsoring clinical trial NCT04228822?

This trial is sponsored by Washington University School of Medicine, which has 1,502 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT04228822 being conducted?

This trial has 1 study location across Missouri. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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