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Impact of a Low-Carbohydrate Diet in Pediatric Type 1 Diabetes

NCT03997409 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 39

Last updated 2023-05-08

Study results available
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Summary

Dietary carbohydrate consumption is a key factor influencing postprandial glycemia for patients with type 1 diabetes mellitus (T1DM). Because post-prandial glucose excursions profoundly influence hemoglobin A1c (HbA1c), therapeutic approaches to mitigate post-prandial hyperglycemia are of great importance. The quantity and source of carbohydrates affect post-prandial glycemia more than any other dietary factor. These findings serve as the physiologic basis for a growing interest in carbohydrate-restricted diets in the management of T1DM despite American Diabetes Association (ADA) guidelines that discourage restricting total carbohydrate intake to less than 130 grams per day. Although case series and prospective studies suggest low-carbohydrate diets (LCD) significantly improve HbA1c for adults with T1DM, data in the pediatric T1DM population is limited. The investigators will conduct a randomized prospective pilot study evaluating glycemic control, lipidemia, and quality of life (QOL) in pediatric T1DM patients on a LCD.

Conditions

Interventions

OTHER

Dietary Intervention

The investigators will prescribe isocaloric diets equaling the estimated energy requirements of the Institute of Medicine with varying macronutrient content in each group.

Sponsors & Collaborators

  • Vanderbilt University Medical Center

    lead OTHER

Principal Investigators

  • Justin M Gregory, MD, MSCI · Vanderbilt University Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2019-11-18
Primary Completion
2021-06-30
Completion
2021-06-30

Countries

  • United States

Study Locations

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Entities

Diseases

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 NCT03997409 on ClinicalTrials.gov