Skip to main content
OpenTrials
Completed

NCT Number: NCT03997409

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Type 1 Diabetes Autoimmune Diseases Diabetes Mellitus Diabetes Mellitus, Type 1 Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

13 year–21 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Vanderbilt University Medical Center

Nashville, Tennessee, 37212, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Change in HbA1c

    Time frame: Baseline to week 12

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

Secondary outcomes

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

    Time frame: Baseline to Week 12

    Percent of time is calculated from data collected from the continuous glucose monitor worn by participants. T1DM participants were instructed in the use of a continuous glucose monitor (CGM) for the monitoring of glycemia during the study. Participants were shown how to upload CGM data into a HIPAA and FDA-compliant cloud-based, data-integration platform for analysis.

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

    Time frame: Baseline to Week 12

    Percent of time is calculated from data collected from the continuous glucose monitor worn by participants. T1DM participants were instructed in the use of a continuous glucose monitor (CGM) for the monitoring of glycemia during the study. Participants were shown how to upload CGM data into a HIPAA and FDA-compliant cloud-based, data-integration platform for analysis.

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

    Time frame: Baseline to Week 12

    Percent of time is calculated from data collected from the continuous glucose monitor worn by participants. T1DM participants were instructed in the use of a continuous glucose monitor (CGM) for the monitoring of glycemia during the study. Participants were shown how to upload CGM data into a HIPAA and FDA-compliant cloud-based, data-integration platform for analysis.

  4. Percent of Time Spent in Hypoglycemia Below 50 mg/dL

    Time frame: Baseline to Week 12

    Percent of time is calculated from data collected from the continuous glucose monitor worn by participants. T1DM participants were instructed in the use of a continuous glucose monitor (CGM) for the monitoring of glycemia during the study. Participants were shown how to upload CGM data into a HIPAA and FDA-compliant cloud-based, data-integration platform for analysis.

  5. Change in Average Blood Glucose

    Time frame: Baseline to 12 weeks

    Change in average blood glucose is calculated from data collected from the continuous glucose monitor worn by participants. T1DM participants were instructed in the use of a continuous glucose monitor (CGM) for the monitoring of glycemia during the study. Participants were shown how to upload CGM data into a HIPAA and FDA-compliant cloud-based, data-integration platform for analysis.

  6. Change in the Blood Glucose Standard Deviation

    Time frame: Baseline to 12 weeks

    Change in the blood glucose standard deviation is calculated from data collected from the continuous glucose monitor worn by participants. T1DM participants were instructed in the use of a continuous glucose monitor (CGM) for the monitoring of glycemia during the study. Participants were shown how to upload CGM data into a HIPAA and FDA-compliant cloud-based, data-integration platform for analysis.

  7. Change in Average Total Daily Dose of Insulin

    Time frame: Baseline to 12 weeks

    Average Total Daily Dose of Insulin is calculated from data collected from the the use of an insulin pump by participants. T1DM participants were instructed in the use of an insulin pump for the adminsitration of insulin during the study. Instructions included administering all insulin via insulin pump and recording all carbohydrates consumed into the insulin pump. T1DM participants were instructed how to upload insulin pump data into a HIPAA and FDA-compliant cloud-based, data-integration platform for analysis.

  8. Change in Average Bolus Amount of Insulin Per Day

    Time frame: Baseline to 12 weeks

    Average bolus amount of Insulin per day is calculated from data collected from the the use of an insulin pump by participants. T1DM participants were instructed in the use of an insulin pump for the adminsitration of insulin during the study. Instructions included administering all insulin via insulin pump and recording all carbohydrates consumed into the insulin pump. T1DM participants were instructed how to upload insulin pump data into a HIPAA and FDA-compliant cloud-based, data-integration platform for analysis.

  9. Change in Average Basal Amount of Insulin Per Day

    Time frame: Baseline to 12 weeks

    Average Basal Amount of Insulin Per Day is calculated from data collected from the the use of an insulin pump by participants. T1DM participants were instructed in the use of an insulin pump for the adminsitration of insulin during the study. Instructions included administering all insulin via insulin pump and recording all carbohydrates consumed into the insulin pump. T1DM participants were instructed how to upload insulin pump data into a HIPAA and FDA-compliant cloud-based, data-integration platform for analysis.

  10. Change in Low Density Lipoprotein Particle Number

    Time frame: Baseline to 12 weeks

    The number of Low Density Lipoprotein Particles (LDL-P) is directly measured using nuclear magnetic resonance (NMR) spectroscopy.

  11. Change in High Density Lipoprotein Particle Number

    Time frame: Baseline to 12 weeks

    The number of High Density Lipoprotein Particles (HDL-P) is directly measured using nuclear magnetic resonance (NMR) spectroscopy.

  12. Change in Small Low Density Lipoprotein Particle Number

    Time frame: Baseline to 12 weeks

    The number of Small Low Density Lipoprotein Particles (LDL-P) is directly measured using nuclear magnetic resonance (NMR) spectroscopy.

  13. Change in Low Density Lipoprotein Size

    Time frame: Baseline to 12 weeks

    The size of Low Density Lipoprotein Particles (LDL-P) is directly measured using nuclear magnetic resonance (NMR) spectroscopy.

  14. Change in Concentration of Serum Ketones (Beta-hydroxybutyrate)

    Time frame: Baseline to 12 weeks

    Change is measured by difference in concentration of serum ketones (beta-hydroxybutyrate)

  15. Change in Score of Pediatric Quality of Life Inventory (PedsQL) Diabetes Module

    Time frame: Baseline to week 12

    The PedsQL 3.0 Teen Report (ages 13-18) is composed of 28 items. Item scaling is a 5-point scale from 0 (never) to 4 (almost always). The total possible range of scores 0-112 Higher scores indicate higher quality of life.

  16. Change in Diabetes Burden as Measured by the Problem Areas in Diabetes: Teen Version (PAID-T) Report

    Time frame: Baseline to week 12

    Diabetes burden was measured using the Problem Areas in Diabetes (PAID-T) parent-report, a measure of how bothersome day-to-day problems are for adolescents with type 1 diabetes. The he PAID-T is a 26 item measure scored on a likert scale from one-to-six with a total possible scale score ranging from 26-156. A lower score represents less burden.

Sponsors and collaborators

Lead sponsor

Vanderbilt University Medical Center

Other

Registry information

Official study title

Impact of a Low-Carbohydrate Diet on Glycemic Control and Lipids in Pediatric Type 1 Diabetes

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Jun 25, 2019
Registry last updated
May 8, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.