Clinical Trials Directory

Trials / Completed

CompletedNCT03997409

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

Impact of a Low-Carbohydrate Diet on Glycemic Control and Lipids in Pediatric Type 1 Diabetes

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
39 (actual)
Sponsor
Vanderbilt University Medical Center · Academic / Other
Sex
All
Age
13 Years – 21 Years
Healthy volunteers
Not accepted

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

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

Timeline

Start date
2019-11-18
Primary completion
2021-06-30
Completion
2021-06-30
First posted
2019-06-25
Last updated
2023-05-08
Results posted
2023-05-08

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT03997409. Inclusion in this directory is not an endorsement.