Impact of a Low-Carbohydrate Diet in Pediatric Type 1 Diabetes
Purpose
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.
Condition
- Type 1 Diabetes
Eligibility
- Eligible Ages
- Between 13 Years and 21 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
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
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Single (Care Provider)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Low Carbohydrate Diet |
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. |
|
|
Active Comparator Standard Carbohydrate Diet |
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. |
|
|
No Intervention No Dietary Recommendations |
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. |
|
More Details
- Status
- Completed
- Sponsor
- Vanderbilt University Medical Center