Clinical trial NCT03997409: Impact of a Low-Carbohydrate Diet in Pediatric Type 1 Diabetes
Official title: Impact of a Low-Carbohydrate Diet on Glycemic Control and Lipids in Pediatric Type 1 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 1 Diabetes
Keywords: Low Carbohydrate Diet
Standard Carbohydrate Diet
Lead sponsor: Vanderbilt University Medical Center
Sponsor class: OTHER
First posted: 2019-06-25
Enrollment: 39
Sex: ALL
Minimum age (years): 13
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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

Primary outcomes:
measure: Change in HbA1c
timeFrame: Baseline to week 12
Secondary outcomes:
measure: Percent of Time Spent in the Glycemic Target of 70 - 140 mg/dL
timeFrame: Baseline to Week 12
measure: Percent of Time Spent Above the Glycemic Target of 140 mg/dL
timeFrame: Baseline to Week 12
measure: Percent of Time Spent Below the Glycemic Target of 70 mg/dL
timeFrame: Baseline to Week 12
measure: Percent of Time Spent in Hypoglycemia Below 50 mg/dL
timeFrame: Baseline to Week 12
measure: Change in Average Blood Glucose
timeFrame: Baseline to 12 weeks
measure: Change in the Blood Glucose Standard Deviation
timeFrame: Baseline to 12 weeks
measure: Change in Average Total Daily Dose of Insulin
timeFrame: Baseline to 12 weeks
measure: Change in Average Bolus Amount of Insulin Per Day
timeFrame: Baseline to 12 weeks
measure: Change in Average Basal Amount of Insulin Per Day
timeFrame: Baseline to 12 weeks
measure: Change in Low Density Lipoprotein Particle Number
timeFrame: Baseline to 12 weeks
measure: Change in High Density Lipoprotein Particle Number
timeFrame: Baseline to 12 weeks
measure: Change in Small Low Density Lipoprotein Particle Number
timeFrame: Baseline to 12 weeks
measure: Change in Low Density Lipoprotein Size
timeFrame: Baseline to 12 weeks
measure: Change in Concentration of Serum Ketones (Beta-hydroxybutyrate)
timeFrame: Baseline to 12 weeks
measure: Change in Score of Pediatric Quality of Life Inventory (PedsQL) Diabetes Module
timeFrame: Baseline to week 12
measure: Change in Diabetes Burden as Measured by the Problem Areas in Diabetes: Teen Version (PAID-T) Report
timeFrame: Baseline to week 12
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
Study officials:
affiliation: Vanderbilt University Medical Center
name: Justin M Gregory, MD, MSCI
role: STUDY_DIRECTOR
References: