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Metabolic Changes Induced by a Very Low Carbohydrate Diet in Youth With Type 1 Diabetes

NCT04955691 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 19

Last updated 2025-10-16

Study results available
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Summary

As more adolescents with type 1 diabetes (T1D) opt to follow very low carbohydrate diets to improve glucose control, it is becoming increasingly important to study the metabolic and neurological changes that occur on these diets and how these effect patient safety. Understanding the impact of dietary changes on metabolic and neurological factors will help guide clinical advice about the overall safety and efficacy of these diets in the pediatric T1D population. This work will be the basis of future studies testing dietary interventions to improve glycemic control and ensure that these dietary interventions are safe for growing youth with T1D.

Conditions

  • Type1diabetes, Low Carbohydrate Diet

Interventions

OTHER

low carbohydrate diet

Participants will engage in a diet that limits carbohydrate intake to 15% of total daily calories for 2 weeks.

OTHER

standard carbohydrate diet

Participants will engage in a diet that recommends standard carbohydrate intake with respect to total daily calories for 2 weeks.

Sponsors & Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

    collaborator NIH

  • Yale University

    lead OTHER

Principal Investigators

  • Laura M Nally, M.D. · Yale University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
12 Years
Max Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-07-29
Primary Completion
2024-08-06
Completion
2024-08-06

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04955691 on ClinicalTrials.gov