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

NCT03997409 | Completed Results

• 1 other identifier: 190851
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

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

Keywords

Low Carbohydrate Diet; Standard Carbohydrate Diet

Outcome Measures

Primary Outcomes (1)

• Change in HbA1c

  HbA1c (%) change will be measured from baseline to 12 weeks

  Baseline to week 12

Secondary Outcomes (16)

• Percent of Time Spent in the Glycemic Target of 70 - 140 mg/dL

  Baseline to Week 12

• Percent of Time Spent Above the Glycemic Target of 140 mg/dL

  Baseline to Week 12

• Percent of Time Spent Below the Glycemic Target of 70 mg/dL

  Baseline to Week 12

• Percent of Time Spent in Hypoglycemia Below 50 mg/dL

  Baseline to Week 12

• Change in Average Blood Glucose

  Baseline to 12 weeks

Study Arms (3)

Low Carbohydrate Diet

EXPERIMENTAL

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.

Other: Dietary Intervention

Standard Carbohydrate Diet

ACTIVE COMPARATOR

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.

Other: Dietary Intervention

No Dietary Recommendations

NO INTERVENTION

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.

Interventions

Dietary Intervention OTHER

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

Low Carbohydrate Diet; Standard Carbohydrate Diet

Eligibility Criteria

• Age: 13 Years - 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Vanderbilt University Medical Center: lead

Study Sites (1)

Vanderbilt University Medical Center

Nashville, Tennessee, 37212, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

Diet Therapy

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Nutrition Therapy; Therapeutics

Results Point of Contact

• Title: Dr. Sara Duffus
• Organization: Vanderbilt University Medical Center

sara.duffus@vumc.org

+1 (615)322-7427

Study Officials

• Justin M Gregory, MD, MSCI

  Vanderbilt University Medical Center

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Fellow, Division of Pediatric Endocrinology

Study Record Dates

• First Submitted: June 21, 2019
• First Posted: June 25, 2019
• Study Start: November 18, 2019
• Primary Completion: June 30, 2021
• Study Completion: June 30, 2021
• Last Updated: May 8, 2023
• Results First Posted: May 8, 2023

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)