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

Vanderbilt University Medical Center

Status: Completed

Conditions: Type 1 Diabetes

Treatments: Other: Dietary Intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT03997409

190851

Details and patient eligibility

About

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.

Enrollment: 39 patients

Sex: All

Ages: 13 to 21 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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39 participants in 3 patient groups

Low Carbohydrate Diet

Experimental group

Description:

The investigators will prescribe isocaloric diets equaling the estimated energy requirements of the Institute of Medicine. Participants on the LCD intervention will consume 25-35% of total daily intake from carbohydrates, 45-65% from fat and 10-30% from protein.

Treatment:

Other: Dietary Intervention

Standard Carbohydrate Diet

Active Comparator group

Description:

The investigators will prescribe isocaloric diets equaling the estimated energy requirements of the Institute of Medicine. Participants on the SCD intervention will consume 45-65% of total daily caloric intake from carbohydrates, 25-35% from fat and 10-30% from protein.

Treatment:

Other: Dietary Intervention

No Dietary Recommendations

No Intervention group

Description:

This group will serve as a control that receives the same number of education sessions as LCD and SCD group to teach general diabetes management but without specific dietary recommendations.