Trial Outcomes & Findings for Metabolic Changes Induced by a Very Low Carbohydrate Diet in Youth With Type 1 Diabetes (NCT NCT04955691)
NCT ID: NCT04955691
Last Updated: 2025-10-16
Results Overview
Time in the optimal glucose range will be operationally defined as the percent time spent in the target range of 70-180 mg/dL during the 2 weeks.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
19 participants
Primary outcome timeframe
2 weeks
Results posted on
2025-10-16
Participant Flow
Participant milestones
| Measure |
Low Carbohydrate Diet, Then Standard Carbohydrate Diet
In this crossover study, participants will be randomized to either a low or standard carbohydrate for 2 weeks. Participants in the low carbohydrate group will limit carbohydrate intake to 15% of total daily calories.
low carbohydrate diet: Participants will engage in a diet that limits carbohydrate intake to 15% of total daily calories for 2 weeks.
|
Standard Carbohydrate Diet, Then Low Carbohydrate Diet
In this crossover study, participants will be randomized to either a low or standard carbohydrate for 2 weeks. Participants in the standard carbohydrate group will follow an ad libitum diet with standard carbohydrate intake.
standard carbohydrate diet: Participants will engage in a diet that recommends standard carbohydrate intake with respect to total daily calories for 2 weeks.
|
|---|---|---|
|
Period 1
STARTED
|
9
|
10
|
|
Period 1
COMPLETED
|
9
|
10
|
|
Period 1
NOT COMPLETED
|
0
|
0
|
|
Washout
STARTED
|
9
|
10
|
|
Washout
COMPLETED
|
9
|
10
|
|
Washout
NOT COMPLETED
|
0
|
0
|
|
Period 2
STARTED
|
9
|
10
|
|
Period 2
Analyzed
|
9
|
10
|
|
Period 2
COMPLETED
|
8
|
8
|
|
Period 2
NOT COMPLETED
|
1
|
2
|
Reasons for withdrawal
| Measure |
Low Carbohydrate Diet, Then Standard Carbohydrate Diet
In this crossover study, participants will be randomized to either a low or standard carbohydrate for 2 weeks. Participants in the low carbohydrate group will limit carbohydrate intake to 15% of total daily calories.
low carbohydrate diet: Participants will engage in a diet that limits carbohydrate intake to 15% of total daily calories for 2 weeks.
|
Standard Carbohydrate Diet, Then Low Carbohydrate Diet
In this crossover study, participants will be randomized to either a low or standard carbohydrate for 2 weeks. Participants in the standard carbohydrate group will follow an ad libitum diet with standard carbohydrate intake.
standard carbohydrate diet: Participants will engage in a diet that recommends standard carbohydrate intake with respect to total daily calories for 2 weeks.
|
|---|---|---|
|
Period 2
Discontinued intervention
|
1
|
2
|
Baseline Characteristics
Metabolic Changes Induced by a Very Low Carbohydrate Diet in Youth With Type 1 Diabetes
Baseline characteristics by cohort
| Measure |
Low Carbohydrate Diet, Then Standard Carbohydrate Diet
n=9 Participants
In this crossover study, participants will be randomized to either a low or standard carbohydrate for 2 weeks. Participants in the low carbohydrate group will limit carbohydrate intake to 15% of total daily calories.
low carbohydrate diet: Participants will engage in a diet that limits carbohydrate intake to 15% of total daily calories for 2 weeks.
|
Standard Carbohydrate Diet, Then Low Carbohydrate Diet
n=10 Participants
In this crossover study, participants will be randomized to either a low or standard carbohydrate for 2 weeks. Participants in the standard carbohydrate group will follow an ad libitum diet with standard carbohydrate intake.
standard carbohydrate diet: Participants will engage in a diet that recommends standard carbohydrate intake with respect to total daily calories for 2 weeks.
|
Total
n=19 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
17 years
STANDARD_DEVIATION 3 • n=5 Participants
|
17 years
STANDARD_DEVIATION 2.67 • n=7 Participants
|
17 years
STANDARD_DEVIATION 2.57 • n=5 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
6 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
8 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
9 participants
n=5 Participants
|
10 participants
n=7 Participants
|
19 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 2 weeksTime in the optimal glucose range will be operationally defined as the percent time spent in the target range of 70-180 mg/dL during the 2 weeks.
Outcome measures
| Measure |
Low Carbohydrate Diet
n=19 Participants
In this crossover study, participants will be randomized to either a low or standard carbohydrate for 2 weeks. Participants in the low carbohydrate group will limit carbohydrate intake to 15% of total daily calories.
low carbohydrate diet: Participants will engage in a diet that limits carbohydrate intake to 15% of total daily calories for 2 weeks.
|
Standard Carbohydrate Diet
n=19 Participants
In this crossover study, participants will be randomized to either a low or standard carbohydrate for 2 weeks. Participants in the standard carbohydrate group will follow an ad libitum diet with standard carbohydrate intake.
standard carbohydrate diet: Participants will engage in a diet that recommends standard carbohydrate intake with respect to total daily calories for 2 weeks.
|
|---|---|---|
|
Percent Time in the Optimal Glucose Range
|
71.20 percentage of time
Interval 68.53 to 73.87
|
62.51 percentage of time
Interval 59.82 to 65.2
|
SECONDARY outcome
Timeframe: 2 weeksTime spent with hypoglycemia will be operationally defined as the percent time spent in the hypoglycemic ranges during 2 weeks of diet. Level 2 hypoglycemia defined as \<54 mg/dL. Level 1 hypoglycemia defined as 54-69 mg/dL.
Outcome measures
| Measure |
Low Carbohydrate Diet
n=19 Participants
In this crossover study, participants will be randomized to either a low or standard carbohydrate for 2 weeks. Participants in the low carbohydrate group will limit carbohydrate intake to 15% of total daily calories.
low carbohydrate diet: Participants will engage in a diet that limits carbohydrate intake to 15% of total daily calories for 2 weeks.
|
Standard Carbohydrate Diet
n=19 Participants
In this crossover study, participants will be randomized to either a low or standard carbohydrate for 2 weeks. Participants in the standard carbohydrate group will follow an ad libitum diet with standard carbohydrate intake.
standard carbohydrate diet: Participants will engage in a diet that recommends standard carbohydrate intake with respect to total daily calories for 2 weeks.
|
|---|---|---|
|
Percent Time Spent With Hypoglycemia.
<54 mg/dL
|
0.42 percentage of time
Interval 0.15 to 0.69
|
0.33 percentage of time
Interval 0.2 to 0.45
|
|
Percent Time Spent With Hypoglycemia.
54-69 mg/dL
|
1.27 percentage of time
Interval 0.91 to 1.62
|
1.46 percentage of time
Interval 1.15 to 1.77
|
SECONDARY outcome
Timeframe: 2 weeksTime spent with hyperglycemia will be operationally defined as the percent time spent in the hyperglycemic ranges during 2 weeks of diet. Level 1 hyperglycemia defined as 181-250 mg/dL. Level 2 hyperglycemia defined as \>250 mg/dL.
Outcome measures
| Measure |
Low Carbohydrate Diet
n=19 Participants
In this crossover study, participants will be randomized to either a low or standard carbohydrate for 2 weeks. Participants in the low carbohydrate group will limit carbohydrate intake to 15% of total daily calories.
low carbohydrate diet: Participants will engage in a diet that limits carbohydrate intake to 15% of total daily calories for 2 weeks.
|
Standard Carbohydrate Diet
n=19 Participants
In this crossover study, participants will be randomized to either a low or standard carbohydrate for 2 weeks. Participants in the standard carbohydrate group will follow an ad libitum diet with standard carbohydrate intake.
standard carbohydrate diet: Participants will engage in a diet that recommends standard carbohydrate intake with respect to total daily calories for 2 weeks.
|
|---|---|---|
|
Percent Time Spent With Hyperglycemia
181-250 mg/dL
|
19.93 percentage of time
Interval 18.23 to 21.63
|
23.20 percentage of time
Interval 21.59 to 24.82
|
|
Percent Time Spent With Hyperglycemia
>250 mg/dL
|
7.19 percentage of time
Interval 5.7 to 8.67
|
12.5 percentage of time
Interval 10.57 to 14.43
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 8 weeeksTo describe how participants feel about and react to following a very low carbohydrate diet, interviews will be conducted. Data will be coded and emerging patterns will be combined into descriptive themes.
Outcome measures
Outcome data not reported
Adverse Events
Low Carbohydrate Diet
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Standard Carbohydrate Diet
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Washout Period
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Low Carbohydrate Diet
n=19 participants at risk
low carbohydrate diet: Participants will engage in a diet that limits carbohydrate intake to 15% of total daily calories for 2 weeks.
|
Standard Carbohydrate Diet
n=19 participants at risk
standard carbohydrate diet: Participants will engage in a diet that recommends standard carbohydrate intake with respect to total daily calories for 2 weeks.
|
Washout Period
n=19 participants at risk
Washout period between the 2 diets
|
|---|---|---|---|
|
General disorders
Nausea/Vomiting with elevated ketone levels
|
10.5%
2/19 • 8 weeks
|
0.00%
0/19 • 8 weeks
|
0.00%
0/19 • 8 weeks
|
|
General disorders
Elevated ketone levels without symptoms
|
10.5%
2/19 • 8 weeks
|
5.3%
1/19 • 8 weeks
|
0.00%
0/19 • 8 weeks
|
|
Injury, poisoning and procedural complications
Infusion site failure with elevated ketones
|
5.3%
1/19 • 8 weeks
|
5.3%
1/19 • 8 weeks
|
0.00%
0/19 • 8 weeks
|
|
Injury, poisoning and procedural complications
Infusion site failure with hyperglycemia
|
10.5%
2/19 • 8 weeks
|
0.00%
0/19 • 8 weeks
|
0.00%
0/19 • 8 weeks
|
|
Gastrointestinal disorders
Hemorrhoids
|
5.3%
1/19 • 8 weeks
|
0.00%
0/19 • 8 weeks
|
0.00%
0/19 • 8 weeks
|
|
Injury, poisoning and procedural complications
Pain at intravenous site
|
5.3%
1/19 • 8 weeks
|
10.5%
2/19 • 8 weeks
|
0.00%
0/19 • 8 weeks
|
|
General disorders
Viral illness with vomiting
|
5.3%
1/19 • 8 weeks
|
0.00%
0/19 • 8 weeks
|
0.00%
0/19 • 8 weeks
|
|
Endocrine disorders
Hypoglycemia during clamp
|
0.00%
0/19 • 8 weeks
|
5.3%
1/19 • 8 weeks
|
0.00%
0/19 • 8 weeks
|
|
Blood and lymphatic system disorders
Anemia
|
0.00%
0/19 • 8 weeks
|
5.3%
1/19 • 8 weeks
|
0.00%
0/19 • 8 weeks
|
|
General disorders
Allergic reaction to cough syrup
|
0.00%
0/19 • 8 weeks
|
5.3%
1/19 • 8 weeks
|
0.00%
0/19 • 8 weeks
|
|
Injury, poisoning and procedural complications
ER visit for foot pain
|
0.00%
0/19 • 8 weeks
|
5.3%
1/19 • 8 weeks
|
0.00%
0/19 • 8 weeks
|
|
General disorders
Allergic reaction to fitness tracker wrist band
|
0.00%
0/19 • 8 weeks
|
5.3%
1/19 • 8 weeks
|
0.00%
0/19 • 8 weeks
|
|
Injury, poisoning and procedural complications
ER visit for foot injury
|
0.00%
0/19 • 8 weeks
|
0.00%
0/19 • 8 weeks
|
5.3%
1/19 • 8 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place