- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03997409
Impact of a Low-Carbohydrate Diet in Pediatric Type 1 Diabetes
June 23, 2022 updated by: Sara Duffus, Vanderbilt University Medical Center
Impact of a Low-Carbohydrate Diet on Glycemic Control and Lipids 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.
Study Overview
Study Type
Interventional
Enrollment (Actual)
39
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Tennessee
-
Nashville, Tennessee, United States, 37212
- Vanderbilt University Medical Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
13 years to 21 years (Child, Adult)
Accepts Healthy Volunteers
No
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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.
|
The investigators will prescribe isocaloric diets equaling the estimated energy requirements of the Institute of Medicine with varying macronutrient content in each group.
|
Active Comparator: 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.
|
The investigators will prescribe isocaloric diets equaling the estimated energy requirements of the Institute of Medicine with varying macronutrient content in each group.
|
No Intervention: 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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in HbA1c
Time Frame: Baseline to week 12
|
HbA1c (%) change will be measured from baseline to 12 weeks
|
Baseline to week 12
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Baseline to Week 12
|
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.
|
Baseline to Week 12
|
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.
|
Baseline to Week 12
|
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.
|
Baseline to Week 12
|
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.
|
Baseline to 12 weeks
|
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.
|
Baseline to 12 weeks
|
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.
|
Baseline to 12 weeks
|
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.
|
Baseline to 12 weeks
|
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.
|
Baseline to 12 weeks
|
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.
|
Baseline to 12 weeks
|
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.
|
Baseline to 12 weeks
|
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.
|
Baseline to 12 weeks
|
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.
|
Baseline to 12 weeks
|
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)
|
Baseline to 12 weeks
|
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.
|
Baseline to week 12
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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.
|
Baseline to week 12
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Director: Justin M Gregory, MD, MSCI, Vanderbilt University Medical Center
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 18, 2019
Primary Completion (Actual)
June 30, 2021
Study Completion (Actual)
June 30, 2021
Study Registration Dates
First Submitted
June 21, 2019
First Submitted That Met QC Criteria
June 21, 2019
First Posted (Actual)
June 25, 2019
Study Record Updates
Last Update Posted (Actual)
May 8, 2023
Last Update Submitted That Met QC Criteria
June 23, 2022
Last Verified
June 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 190851
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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