Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in HbA1c | HbA1c (%) change will be measured from baseline to 12 weeks | Baseline to week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Justin M Gregory, MD, MSCI | Vanderbilt University Medical Center | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vanderbilt University Medical Center | Nashville | Tennessee | 37212 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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. 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. |
| FG001 | 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. 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. |
| FG002 | 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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. 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in HbA1c | HbA1c (%) change will be measured from baseline to 12 weeks | Posted | Median | Inter-Quartile Range | percentage | Baseline to week 12 |
|
12 weeks
Adverse event information was collected for any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Adverse events were collected from the time the consent was signed through participant completion
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. 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. |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Sara Duffus | Vanderbilt University Medical Center | +1 (615)322-7427 | sara.duffus@vumc.org |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 25, 2020 | Jun 21, 2022 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Nov 1, 2019 | Oct 20, 2021 | ICF_000.pdf |
Not provided
| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D004035 | Diet Therapy |
| ID | Term |
|---|---|
| D044623 | Nutrition Therapy |
| D013812 | Therapeutics |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Baseline to Week 12 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| Change in Concentration of Serum Ketones (Beta-hydroxybutyrate) | 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 | 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 |
| 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 |
| Lost to Follow-up |
|
| BG001 | 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. 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. |
| BG002 | 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. |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| OG002 | 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. |
|
|
| 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. | Data was not collected for the following participants due to missed study visit: Low Carb Diet: 1 participant; Standard Carb Diet: 1 participant | Posted | Median | Inter-Quartile Range | percentage | 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. | Data was not collected for the following participants due to missed study visit: Low Carb Diet: 1 participant; Standard Carb Diet: 1 participant | Posted | Median | Inter-Quartile Range | percentage | 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. | Data was not collected for the following participants due to missed study visit: Low Carb Diet: 1 participant; Standard Carb Diet: 1 participant | Posted | Median | Inter-Quartile Range | percentage | 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. | Data was not collected for the following participants due to missed study visit: Low Carb Diet: 1 participant; Standard Carb Diet: 1 participant | Posted | Median | Inter-Quartile Range | percentage | 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. | Data was not collected for the following participants due to missed study visit: Low Carb Diet: 1 participant; Standard Carb Diet: 1 participant | Posted | Median | Inter-Quartile Range | mg/dL | 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. | Data was not collected for the following participants due to missed study visit: Low Carb Diet: 1 participant; Standard Carb Diet: 1 participant | Posted | Median | Inter-Quartile Range | mg/dL | 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. | Data was not collected for the following participants due to missed study visit: Low Carb Diet: 1 participant; Standard Carb Diet: 1 participant | Posted | Median | Inter-Quartile Range | units of insulin/day | 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. | Data was not collected for the following participants due to missed study visit: Low Carb Diet: 1 participant; Standard Carb Diet: 1 participant | Posted | Median | Inter-Quartile Range | units of insulin/day | 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. | Data was not collected for the following participants due to missed study visit: Low Carb Diet: 1 participant; Standard Carb Diet: 1 participant | Posted | Median | Inter-Quartile Range | units of insulin / day | 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. | Data was not collected for the following participants due to missed study visit: Low Carb Diet: 2 participants; Standard Carb Diet: 2 participants | Posted | Median | Inter-Quartile Range | Nanomoles per liter (nmol/L) | 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. | Data was not collected for the following participants due to missed study visit: Low Carb Diet: 2 participants; Standard Carb Diet: 2 participants | Posted | Median | Inter-Quartile Range | Nanomoles per liter (nmol/L) | 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. | Data was not collected for the following participants due to missed study visit: Low Carb Diet: 2 participants; Standard Carb Diet: 2 participants | Posted | Median | Inter-Quartile Range | Nanomoles per liter (nmol/L) | 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. | Data was not collected for the following participants due to missed study visit: Low Carb Diet: 2 participants; Standard Carb Diet: 2 participants | Posted | Median | Inter-Quartile Range | nanometer (nm) | 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) | Data was not collected for the following participants due to missed study visit: Low Carb Diet: 2 participants; Standard Carb Diet: 2 participants | Posted | Median | Inter-Quartile Range | Millimoles per liter (mmol/L) | 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. | Data was not collected for the following participants due to missed study visit: Low Carb Diet: 3 participants; Standard Carb Diet: 4 participants; No Dietary Recommendations: 2 participants | Posted | Median | Inter-Quartile Range | units on a scale | 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. | Data was not collected for the following participants due to missed study visit: Low Carb Diet: 3 participants; Standard Carb Diet: 4 participants; No Dietary Recommendations: 2 participants | Posted | Median | Inter-Quartile Range | units on a scale | Baseline to week 12 |
|
|
|
| 0 |
| 14 |
| 0 |
| 14 |
| 0 |
| 14 |
| EG001 | 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. 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. | 0 | 13 | 0 | 13 | 0 | 13 |
| EG002 | 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. | 0 | 12 | 0 | 12 | 0 | 12 |
Not provided
Not provided
Not provided
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |