N/A N=39 Randomized Single-blind Treatment

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

Type 1 Diabetes

Bottom Line

View on ClinicalTrials.gov: NCT03997409 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

May 2023

Primary outcome: Primary: Change in HbA1c — 0.4; 0.3; -0.2 percentage

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Dietary Intervention (Other)
Age: Pediatric, Adult · 13+ yrs
Sex: All
Sponsor: Vanderbilt University Medical Center
Primary completion: Jun 2021

Outcome Measures

Outcome	Result	p-value
PRIMARY Change in HbA1c	0.4; 0.3; -0.2	—
SECONDARY Percent of Time Spent in the Glycemic Target of 70 - 140 mg/dL	-3; -8.9; 3.4	—
SECONDARY Percent of Time Spent Above the Glycemic Target of 140 mg/dL	-1.4; -1.9; -1.9	—
SECONDARY Percent of Time Spent Below the Glycemic Target of 70 mg/dL	0; 0; -0.2	—
SECONDARY Percent of Time Spent in Hypoglycemia Below 50 mg/dL	0; 0.1; 0	—
SECONDARY Change in Average Blood Glucose	6; 7; -11.5	—
SECONDARY Change in the Blood Glucose Standard Deviation	0; 0; -3	—
SECONDARY Change in Average Total Daily Dose of Insulin	2.7; 4.8; -1.9	—
SECONDARY Change in Average Bolus Amount of Insulin Per Day	3.3; 5.1; -1.7	—
SECONDARY Change in Average Basal Amount of Insulin Per Day	0.2; -0.2; 0.2	—
SECONDARY Change in Low Density Lipoprotein Particle Number	30; -41; 47	—
SECONDARY Change in High Density Lipoprotein Particle Number	-1; 1.5; -2.3	—
SECONDARY Change in Small Low Density Lipoprotein Particle Number	-2.5; 40; -12	—
SECONDARY Change in Low Density Lipoprotein Size	0; -0.15; 0.2	—
SECONDARY Change in Concentration of Serum Ketones (Beta-hydroxybutyrate)	-0.04; -0.03; -0.02	—
SECONDARY Change in Score of Pediatric Quality of Life Inventory (PedsQL) Diabetes Module	-5; -5.5; -3	—
SECONDARY Change in Diabetes Burden as Measured by the Problem Areas in Diabetes: Teen Version (PAID-T) Report	3; -5.5; 4	—

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.

Eligibility Criteria

Inclusion Criteria

Diagnosed with T1DM for at least 12 months
Age 13 to 21 years
Total daily dose of insulin 0.5 to 1.25 units/kg/day
Current use of an insulin pump and CGM
HbA1c between 7% and 10%
Tanner stage 3 to 5 on physical exam
Participant or parent of participant use of smart phone
Able to read and speak English

Exclusion Criteria

Any episode of diabetic ketoacidosis (DKA) in the last 12 months
Any episode of severe hypoglycemia (defined as requiring assistance from another person, including coma, seizures, or episodes requiring glucagon, IV dextrose or oral carbohydrate administered by another person) in the last 12 months
Any prior abnormal fasting lipid panel (LDL > 130)
Additional dietary restrictions
Following a weight-loss or otherwise restrictive diet
Use of medication or supplements other than insulin to control blood glucose
Use of medication or other supplements to lower lipids
Pregnancy or breast feeding
History of hemoglobinopathy

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03997409). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.