Trial Outcomes & Findings for Very Low Carbohydrate Diet as an Adjunctive Therapy for Youth Type 1 Diabetes (NCT NCT04082884)
NCT ID: NCT04082884
Last Updated: 2024-02-15
Results Overview
The target range is 70 mg/dL - 180 mg/dL based on sensor-derived glucose levels. The outcome is reflected as the percentage of time spent in this range during the time frame.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
6 participants
Primary outcome timeframe
2 weeks per intervention, up to 7 weeks
Results posted on
2024-02-15
Participant Flow
Participant milestones
| Measure |
Overall Participants
Participants will follow a high protein very low carbohydrate diet (VLCD) for 2 weeks. This will be 11% of caloric intake from carbohydrates, 54% of calories from protein, and 35% of calories from fat. Immediately following this, participants will follow a high fat very low carbohydrate diet (VLCD) which will be with 11% caloric intake from carbohydrates, 23% from protein, 66% from fat.
Very Low Carbohydrate Diet: A very low carbohydrate diet (VLCD), is defined as limiting carbohydrate intake to 11% of total daily caloric intake.
The high fat very low carbohydrate diet was removed from the study after the 4th participant completed the study.
|
|---|---|
|
Overall Study
STARTED
|
6
|
|
Overall Study
Completed Standard Diet
|
5
|
|
Overall Study
1 Week Transition to Low Carbohydrate Diet Completed
|
5
|
|
Overall Study
High Protein Low Carbohydrate Completed
|
5
|
|
Overall Study
High Fat Low Carbohydrate Completed
|
4
|
|
Overall Study
COMPLETED
|
5
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
Overall Participants
Participants will follow a high protein very low carbohydrate diet (VLCD) for 2 weeks. This will be 11% of caloric intake from carbohydrates, 54% of calories from protein, and 35% of calories from fat. Immediately following this, participants will follow a high fat very low carbohydrate diet (VLCD) which will be with 11% caloric intake from carbohydrates, 23% from protein, 66% from fat.
Very Low Carbohydrate Diet: A very low carbohydrate diet (VLCD), is defined as limiting carbohydrate intake to 11% of total daily caloric intake.
The high fat very low carbohydrate diet was removed from the study after the 4th participant completed the study.
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
Baseline Characteristics
Very Low Carbohydrate Diet as an Adjunctive Therapy for Youth Type 1 Diabetes
Baseline characteristics by cohort
| Measure |
Overall Participants
n=6 Participants
Participants were youth ages 14-23 with a diagnosis of type 1 diabetes.
|
|---|---|
|
Age, Customized
Age in years categorized · 10-19 years
|
3 Participants
n=5 Participants
|
|
Age, Customized
Age in years categorized · 20-29 years
|
3 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
6 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
6 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 2 weeks per intervention, up to 7 weeksPopulation: 5 completed participants
The target range is 70 mg/dL - 180 mg/dL based on sensor-derived glucose levels. The outcome is reflected as the percentage of time spent in this range during the time frame.
Outcome measures
| Measure |
Overall Participants
n=5 Participants
Participants will follow specified diets for 2 weeks: standard carbohydrate, high protein/very low carbohydrate diet and high fat/very low carbohydrate diet.
|
|---|---|
|
Percentage of Time in Target Range of 70-180 mg/dL.
Baseline
|
49.64 percent time spent 70 mg/dL - 180 mg/dL
Standard Deviation 19.92
|
|
Percentage of Time in Target Range of 70-180 mg/dL.
Standard Carbohydrate Diet
|
48.86 percent time spent 70 mg/dL - 180 mg/dL
Standard Deviation 15.41
|
|
Percentage of Time in Target Range of 70-180 mg/dL.
High Protein Very Low Carbohydrate Diet
|
60.78 percent time spent 70 mg/dL - 180 mg/dL
Standard Deviation 16.57
|
|
Percentage of Time in Target Range of 70-180 mg/dL.
High Fat Very Low Carbohydrate Diet
|
50.1 percent time spent 70 mg/dL - 180 mg/dL
Standard Deviation 16.83
|
SECONDARY outcome
Timeframe: 2 weeks per intervention, up to 7 weeksPopulation: 5 completed participants
The percent of time spent \> 180 mg/dL to 250 mg/dl based on sensor-derived glucose values. Reflected is the percentage of time spent in the range of 181-250 mg/dL.
Outcome measures
| Measure |
Overall Participants
n=5 Participants
Participants will follow specified diets for 2 weeks: standard carbohydrate, high protein/very low carbohydrate diet and high fat/very low carbohydrate diet.
|
|---|---|
|
Percentage of Time Spent > 180 mg/dL to 250 mg/dl
Baseline
|
25.7 percent time spent > 180 to 250 mg/dL
Standard Deviation 3.19
|
|
Percentage of Time Spent > 180 mg/dL to 250 mg/dl
Standard Carbohydrate
|
25.36 percent time spent > 180 to 250 mg/dL
Standard Deviation 5.15
|
|
Percentage of Time Spent > 180 mg/dL to 250 mg/dl
High Protein/Very Low Carbohydrate
|
21.94 percent time spent > 180 to 250 mg/dL
Standard Deviation 5.75
|
|
Percentage of Time Spent > 180 mg/dL to 250 mg/dl
High Fat/Very Low Carbohydrate
|
21.32 percent time spent > 180 to 250 mg/dL
Standard Deviation 2.65
|
SECONDARY outcome
Timeframe: 2 weeks per intervention, up to 7 weeksPopulation: 5 completed participants
The percent of time spent \> 250 mg/dL based on sensor-derived glucose values. Presented is the percentage of time people spent in the range.
Outcome measures
| Measure |
Overall Participants
n=5 Participants
Participants will follow specified diets for 2 weeks: standard carbohydrate, high protein/very low carbohydrate diet and high fat/very low carbohydrate diet.
|
|---|---|
|
Percent Time Spent > 250 mg/dL Based on Sensor-derived Glucose Values
Baseline
|
22.58 percent time spent > 250 mg/dL
Standard Deviation 19.24
|
|
Percent Time Spent > 250 mg/dL Based on Sensor-derived Glucose Values
Standard Carbohydrate
|
21.36 percent time spent > 250 mg/dL
Standard Deviation 14.07
|
|
Percent Time Spent > 250 mg/dL Based on Sensor-derived Glucose Values
High Protein/Very Low Carbohydrate
|
14.32 percent time spent > 250 mg/dL
Standard Deviation 13.17
|
|
Percent Time Spent > 250 mg/dL Based on Sensor-derived Glucose Values
High Fat/Very Low Carbohydrate
|
24.95 percent time spent > 250 mg/dL
Standard Deviation 17.68
|
SECONDARY outcome
Timeframe: 2 weeks per intervention, up to 7 weeksPopulation: 5 completed participants
The percent of time spent \> = 55 to \< 70 mg/dL based on sensor-derived glucose values. Reflected is the percentage of time within range.
Outcome measures
| Measure |
Overall Participants
n=5 Participants
Participants will follow specified diets for 2 weeks: standard carbohydrate, high protein/very low carbohydrate diet and high fat/very low carbohydrate diet.
|
|---|---|
|
Percent of Time Spent > = 55 to < 70 mg/dL Based on Sensor-derived Glucose Values
Baseline
|
1.22 percent time spent > = 55 to < 70 mg/dL
Standard Deviation 1.61
|
|
Percent of Time Spent > = 55 to < 70 mg/dL Based on Sensor-derived Glucose Values
Standard Carbohydrate
|
2.96 percent time spent > = 55 to < 70 mg/dL
Standard Deviation 3.19
|
|
Percent of Time Spent > = 55 to < 70 mg/dL Based on Sensor-derived Glucose Values
High Protein/Very Low Carbohydrate
|
2.26 percent time spent > = 55 to < 70 mg/dL
Standard Deviation 1.93
|
|
Percent of Time Spent > = 55 to < 70 mg/dL Based on Sensor-derived Glucose Values
High Fat/Very Low Carbohydrate
|
2.65 percent time spent > = 55 to < 70 mg/dL
Standard Deviation 2.28
|
SECONDARY outcome
Timeframe: 2 weeks per intervention, up to 7 weeksPopulation: 5 completed participants
The percent of time spent \< 55 mg/dL based on sensor-derived glucose values during the timeframe. Presented is the percentage of overall time spent in the specified range.
Outcome measures
| Measure |
Overall Participants
n=5 Participants
Participants will follow specified diets for 2 weeks: standard carbohydrate, high protein/very low carbohydrate diet and high fat/very low carbohydrate diet.
|
|---|---|
|
Percent Time Spent < 55 mg/dL Based on Sensor-derived Glucose Values
Baseline
|
0.68 percentage time spent < 55 mg/dL
Standard Deviation 1.29
|
|
Percent Time Spent < 55 mg/dL Based on Sensor-derived Glucose Values
Standard Carbohydrate
|
1.46 percentage time spent < 55 mg/dL
Standard Deviation 2.23
|
|
Percent Time Spent < 55 mg/dL Based on Sensor-derived Glucose Values
High Protein/Very Low Carbohydrate
|
0.68 percentage time spent < 55 mg/dL
Standard Deviation 0.59
|
|
Percent Time Spent < 55 mg/dL Based on Sensor-derived Glucose Values
High Fat/Very Low Carbohydrate
|
1.15 percentage time spent < 55 mg/dL
Standard Deviation 1.06
|
SECONDARY outcome
Timeframe: 2 weeks per intervention, up to 7 weeksPopulation: 5 completed participants
The total daily insulin dose will be defined as the average total daily insulin dose will be calculated over 2 weeks. Values represent the mean units/kg/day for the 2 week period.
Outcome measures
| Measure |
Overall Participants
n=5 Participants
Participants will follow specified diets for 2 weeks: standard carbohydrate, high protein/very low carbohydrate diet and high fat/very low carbohydrate diet.
|
|---|---|
|
Total Daily Insulin Dose
Baseline
|
0.78 units/kg/day
Standard Deviation 0.09
|
|
Total Daily Insulin Dose
Standard Carbohydrate
|
0.82 units/kg/day
Standard Deviation 0.06
|
|
Total Daily Insulin Dose
High Protein/Very Low Carbohydrate
|
0.60 units/kg/day
Standard Deviation 0.08
|
|
Total Daily Insulin Dose
High Fat/Very Low Carbohydrate
|
0.69 units/kg/day
Standard Deviation 0.12
|
SECONDARY outcome
Timeframe: 2 weeks per intervention, up to 7 weeksPopulation: 5 completed participants
The average sensor glucose level recorded by the continuous glucose monitor over the 2 week dietary period in mg/dL.
Outcome measures
| Measure |
Overall Participants
n=5 Participants
Participants will follow specified diets for 2 weeks: standard carbohydrate, high protein/very low carbohydrate diet and high fat/very low carbohydrate diet.
|
|---|---|
|
Average Sensor Glucose Level
Baseline
|
193 mg/dL
Standard Deviation 44
|
|
Average Sensor Glucose Level
Standard Carbohydrate
|
186 mg/dL
Standard Deviation 35
|
|
Average Sensor Glucose Level
High Protein/Very Low Carbohydrate
|
169 mg/dL
Standard Deviation 30
|
|
Average Sensor Glucose Level
High Fat/Very Low Carbohydrate
|
193 mg/dL
Standard Deviation 41
|
Adverse Events
Overall Participants
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place