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

Type 1 Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03997409
• Other study ID #: 190851
• Status: Completed
• Phase: N/A
• Start date: November 18, 2019
• Est. completion date: June 30, 2021

Study information

• Verified date: June 2022
• Source: Vanderbilt University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 39
• Est. completion date: June 30, 2021
• Est. primary completion date: June 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 13 Years to 21 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Type 1 Diabetes

Intervention

Other:
• 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.

Locations

Country	Name	City	State
United States	Vanderbilt University Medical Center	Nashville	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
Vanderbilt University Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in HbA1c	HbA1c (%) change will be measured from baseline to 12 weeks	Baseline to week 12
Secondary	Percent of Time Spent in the Glycemic Target of 70 - 140 mg/dL	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.	Baseline to Week 12
Secondary	Percent of Time Spent Above the Glycemic Target of 140 mg/dL	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.	Baseline to Week 12
Secondary	Percent of Time Spent Below the Glycemic Target of 70 mg/dL	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.	Baseline to Week 12
Secondary	Percent of Time Spent in Hypoglycemia Below 50 mg/dL	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.	Baseline to Week 12
Secondary	Change in Average Blood Glucose	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.	Baseline to 12 weeks
Secondary	Change in the Blood Glucose Standard Deviation	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.	Baseline to 12 weeks
Secondary	Change in Average Total Daily Dose of Insulin	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.	Baseline to 12 weeks
Secondary	Change in Average Bolus Amount of Insulin Per Day	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.	Baseline to 12 weeks
Secondary	Change in Average Basal Amount of Insulin Per Day	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.	Baseline to 12 weeks
Secondary	Change in Low Density Lipoprotein Particle Number	The number of Low Density Lipoprotein Particles (LDL-P) is directly measured using nuclear magnetic resonance (NMR) spectroscopy.	Baseline to 12 weeks
Secondary	Change in High Density Lipoprotein Particle Number	The number of High Density Lipoprotein Particles (HDL-P) is directly measured using nuclear magnetic resonance (NMR) spectroscopy.	Baseline to 12 weeks
Secondary	Change in Small Low Density Lipoprotein Particle Number	The number of Small Low Density Lipoprotein Particles (LDL-P) is directly measured using nuclear magnetic resonance (NMR) spectroscopy.	Baseline to 12 weeks
Secondary	Change in Low Density Lipoprotein Size	The size of Low Density Lipoprotein Particles (LDL-P) is directly measured using nuclear magnetic resonance (NMR) spectroscopy.	Baseline to 12 weeks
Secondary	Change in Concentration of Serum Ketones (Beta-hydroxybutyrate)	Change is measured by difference in concentration of serum ketones (beta-hydroxybutyrate)	Baseline to 12 weeks
Secondary	Change in Score of Pediatric Quality of Life Inventory (PedsQL) Diabetes Module	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.	Baseline to week 12
Secondary	Change in Diabetes Burden as Measured by the Problem Areas in Diabetes: Teen Version (PAID-T) Report	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.	Baseline to week 12