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

NCT ID: NCT03997409

Last Updated: 2023-05-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 39 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-11-18
• Study Completion Date: 2021-06-30

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.

Conditions

Type 1 Diabetes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Dietary Intervention

Intervention Type: OTHER

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

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.

Group Type: ACTIVE_COMPARATOR

Dietary Intervention

Intervention Type: OTHER

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

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Dietary Intervention

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

Intervention Type: OTHER

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

• Minimum Eligible Age: 13 Years
• Maximum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Vanderbilt University Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Sara Duffus

Clinical Fellow, Division of Pediatric Endocrinology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Justin M Gregory, MD, MSCI

Role: STUDY_DIRECTOR

Vanderbilt University Medical Center

Locations

Vanderbilt University Medical Center

Nashville, Tennessee, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

190851

Identifier Type: -

Identifier Source: org_study_id