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

Primary Purpose

Type 1 Diabetes

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Dietary Intervention
Sponsored by
Vanderbilt University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 1 Diabetes focused on measuring Low Carbohydrate Diet, Standard Carbohydrate Diet

Eligibility Criteria

13 Years - 21 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Vanderbilt University Medical Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

No Intervention

Arm Label

Low Carbohydrate Diet

Standard Carbohydrate Diet

No Dietary Recommendations

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Change in Low Density Lipoprotein Size
The size of Low Density Lipoprotein Particles (LDL-P) is directly measured using nuclear magnetic resonance (NMR) spectroscopy.
Change in Concentration of Serum Ketones (Beta-hydroxybutyrate)
Change is measured by difference in concentration of serum ketones (beta-hydroxybutyrate)
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.
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.

Full Information

First Posted
June 21, 2019
Last Updated
June 23, 2022
Sponsor
Vanderbilt University Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT03997409
Brief Title
Impact of a Low-Carbohydrate Diet in Pediatric Type 1 Diabetes
Official Title
Impact of a Low-Carbohydrate Diet on Glycemic Control and Lipids in Pediatric Type 1 Diabetes
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Completed
Study Start Date
November 18, 2019 (Actual)
Primary Completion Date
June 30, 2021 (Actual)
Study Completion Date
June 30, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Vanderbilt University Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 1 Diabetes
Keywords
Low Carbohydrate Diet, Standard Carbohydrate Diet

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care Provider
Allocation
Randomized
Enrollment
39 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Low Carbohydrate Diet
Arm Type
Experimental
Arm Description
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.
Arm Title
Standard Carbohydrate Diet
Arm Type
Active Comparator
Arm Description
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.
Arm Title
No Dietary Recommendations
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Dietary Intervention
Intervention Description
The investigators will prescribe isocaloric diets equaling the estimated energy requirements of the Institute of Medicine with varying macronutrient content in each group.
Primary Outcome Measure Information:
Title
Change in HbA1c
Description
HbA1c (%) change will be measured from baseline to 12 weeks
Time Frame
Baseline to week 12
Secondary Outcome Measure Information:
Title
Percent of Time Spent in the Glycemic Target of 70 - 140 mg/dL
Description
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.
Time Frame
Baseline to Week 12
Title
Percent of Time Spent Above the Glycemic Target of 140 mg/dL
Description
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.
Time Frame
Baseline to Week 12
Title
Percent of Time Spent Below the Glycemic Target of 70 mg/dL
Description
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.
Time Frame
Baseline to Week 12
Title
Percent of Time Spent in Hypoglycemia Below 50 mg/dL
Description
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.
Time Frame
Baseline to Week 12
Title
Change in Average Blood Glucose
Description
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.
Time Frame
Baseline to 12 weeks
Title
Change in the Blood Glucose Standard Deviation
Description
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.
Time Frame
Baseline to 12 weeks
Title
Change in Average Total Daily Dose of Insulin
Description
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.
Time Frame
Baseline to 12 weeks
Title
Change in Average Bolus Amount of Insulin Per Day
Description
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.
Time Frame
Baseline to 12 weeks
Title
Change in Average Basal Amount of Insulin Per Day
Description
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.
Time Frame
Baseline to 12 weeks
Title
Change in Low Density Lipoprotein Particle Number
Description
The number of Low Density Lipoprotein Particles (LDL-P) is directly measured using nuclear magnetic resonance (NMR) spectroscopy.
Time Frame
Baseline to 12 weeks
Title
Change in High Density Lipoprotein Particle Number
Description
The number of High Density Lipoprotein Particles (HDL-P) is directly measured using nuclear magnetic resonance (NMR) spectroscopy.
Time Frame
Baseline to 12 weeks
Title
Change in Small Low Density Lipoprotein Particle Number
Description
The number of Small Low Density Lipoprotein Particles (LDL-P) is directly measured using nuclear magnetic resonance (NMR) spectroscopy.
Time Frame
Baseline to 12 weeks
Title
Change in Low Density Lipoprotein Size
Description
The size of Low Density Lipoprotein Particles (LDL-P) is directly measured using nuclear magnetic resonance (NMR) spectroscopy.
Time Frame
Baseline to 12 weeks
Title
Change in Concentration of Serum Ketones (Beta-hydroxybutyrate)
Description
Change is measured by difference in concentration of serum ketones (beta-hydroxybutyrate)
Time Frame
Baseline to 12 weeks
Title
Change in Score of Pediatric Quality of Life Inventory (PedsQL) Diabetes Module
Description
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.
Time Frame
Baseline to week 12
Title
Change in Diabetes Burden as Measured by the Problem Areas in Diabetes: Teen Version (PAID-T) Report
Description
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.
Time Frame
Baseline to week 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
13 Years
Maximum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Justin M Gregory, MD, MSCI
Organizational Affiliation
Vanderbilt University Medical Center
Official's Role
Study Director
Facility Information:
Facility Name
Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37212
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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

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