Trial Outcomes & Findings for Exercise Snacks and Glutamine to Improve Glucose Control in Adolescents With Type 1 Diabetes (NCT NCT03199638)
NCT ID: NCT03199638
Last Updated: 2023-08-14
Results Overview
change in glycated hemoglobin
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
14 participants
Primary outcome timeframe
baseline vs. at 3 months
Results posted on
2023-08-14
Participant Flow
Participant milestones
| Measure |
an Exercise Group,
in which subjects will perform daily 'exercise snacks' within 30 min before breakfast, lunch, and dinner
|
Exercise + Glutamine Group
(in which subjects will receive a glutamine drink (0.25g/kg) before breakfast, lunch, and dinner; and perform 'exercise snacks' before each meal.
|
|---|---|---|
|
Overall Study
STARTED
|
7
|
7
|
|
Overall Study
COMPLETED
|
7
|
5
|
|
Overall Study
NOT COMPLETED
|
0
|
2
|
Reasons for withdrawal
| Measure |
an Exercise Group,
in which subjects will perform daily 'exercise snacks' within 30 min before breakfast, lunch, and dinner
|
Exercise + Glutamine Group
(in which subjects will receive a glutamine drink (0.25g/kg) before breakfast, lunch, and dinner; and perform 'exercise snacks' before each meal.
|
|---|---|---|
|
Overall Study
inability to drink glutamine during regularly
|
0
|
2
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Exercise + Glutamine Group
n=5 Participants
group performed 'exercise snacks' and received a dietary glutamine supplement
|
Exercise Group
n=7 Participants
group performed 'exercise snacks' only
|
Total
n=12 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
5 Participants
n=12 Participants
|
|
Age, Categorical
<=18 years
|
4 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
10 Participants
n=12 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=12 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=12 Participants
|
|
Age, Continuous
|
17 years
STANDARD_DEVIATION 1 • n=5 Participants
|
15 years
STANDARD_DEVIATION 1 • n=7 Participants
|
16 years
STANDARD_DEVIATION 1 • n=12 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
7 Participants
n=12 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
5 participants
n=5 Participants
|
7 participants
n=7 Participants
|
12 participants
n=12 Participants
|
|
Height
|
165 cm
STANDARD_DEVIATION 4 • n=5 Participants
|
166 cm
STANDARD_DEVIATION 7 • n=7 Participants
|
165.6 cm
STANDARD_DEVIATION 5.1 • n=12 Participants
|
|
Weight
|
65 kg
STANDARD_DEVIATION 7 • n=5 Participants
|
64 kg
STANDARD_DEVIATION 9 • n=7 Participants
|
64 kg
STANDARD_DEVIATION 8 • n=12 Participants
|
|
Body Mass Index (BMI)
|
24.0 kg/m²
STANDARD_DEVIATION 2.3 • n=5 Participants
|
23.0 kg/m²
STANDARD_DEVIATION 2.5 • n=7 Participants
|
23.2 kg/m²
STANDARD_DEVIATION 2.4 • n=12 Participants
|
|
BMI percentile
|
79 %
STANDARD_DEVIATION 12 • n=5 Participants
|
78 %
STANDARD_DEVIATION 12 • n=7 Participants
|
78.5 %
STANDARD_DEVIATION 11.1 • n=12 Participants
|
|
Duration of diabetes
|
6.4 years
STANDARD_DEVIATION 5.7 • n=5 Participants
|
7.8 years
STANDARD_DEVIATION 5.1 • n=7 Participants
|
7.2 years
STANDARD_DEVIATION 5.1 • n=12 Participants
|
|
HbA1C
|
8.3 percentage of total hemoglobin
STANDARD_DEVIATION 0.8 • n=5 Participants
|
7.9 percentage of total hemoglobin
STANDARD_DEVIATION 0.4 • n=7 Participants
|
8.1 percentage of total hemoglobin
STANDARD_DEVIATION 0.6 • n=12 Participants
|
PRIMARY outcome
Timeframe: baseline vs. at 3 monthschange in glycated hemoglobin
Outcome measures
| Measure |
an Exercise Group
n=7 Participants
in which subjects will perform daily 'exercise snacks' within 30 min before breakfast, lunch, and/or dinner or bedtime snack, along with a placebo drink which will be given before breakfast and dinner (twice daily);
Exercise: short bouts of exercise ('exercise snacks') 3 times daily for 3 months
|
an Exercise + Glutamine Group
n=5 Participants
in which subjects will receive a glutamine drink (0.25 g/kg per dose) before breakfast and dinner (twice daily), and perform 'exercise snacks' before each meal
Glutamine vs. Placebo: oral supplementation with either glutamine or placebo twice daily for 3 months
Exercise: short bouts of exercise ('exercise snacks') 3 times daily for 3 months
|
|---|---|---|
|
HbA1c, Glycated Hemoglobin
baseline
|
7.9 percentage of total hemoglobin
Standard Deviation 0.4
|
8.3 percentage of total hemoglobin
Standard Deviation 0.8
|
|
HbA1c, Glycated Hemoglobin
at 3 months
|
8.0 percentage of total hemoglobin
Standard Deviation 0.6
|
8.4 percentage of total hemoglobin
Standard Deviation 0.5
|
SECONDARY outcome
Timeframe: before vs. at 3 monthsMAGE describes the average amplitude of glycemic variations measured using continuous glucose monitoring (CGM)
Outcome measures
| Measure |
an Exercise Group
n=7 Participants
in which subjects will perform daily 'exercise snacks' within 30 min before breakfast, lunch, and/or dinner or bedtime snack, along with a placebo drink which will be given before breakfast and dinner (twice daily);
Exercise: short bouts of exercise ('exercise snacks') 3 times daily for 3 months
|
an Exercise + Glutamine Group
n=5 Participants
in which subjects will receive a glutamine drink (0.25 g/kg per dose) before breakfast and dinner (twice daily), and perform 'exercise snacks' before each meal
Glutamine vs. Placebo: oral supplementation with either glutamine or placebo twice daily for 3 months
Exercise: short bouts of exercise ('exercise snacks') 3 times daily for 3 months
|
|---|---|---|
|
Change in the Mean Amplitude of Glycemic Excursions (MAGE)
baseline
|
129 mg/dL
Standard Deviation 133
|
108 mg/dL
Standard Deviation 127
|
|
Change in the Mean Amplitude of Glycemic Excursions (MAGE)
at 3 months
|
139 mg/dL
Standard Deviation 122
|
123 mg/dL
Standard Deviation 103
|
SECONDARY outcome
Timeframe: baseline vs. at 3 monthsPercent of BG between 70 and 180 mg/dL, as measured using Continuous Glucose Monitor (CGM)
Outcome measures
| Measure |
an Exercise Group
n=7 Participants
in which subjects will perform daily 'exercise snacks' within 30 min before breakfast, lunch, and/or dinner or bedtime snack, along with a placebo drink which will be given before breakfast and dinner (twice daily);
Exercise: short bouts of exercise ('exercise snacks') 3 times daily for 3 months
|
an Exercise + Glutamine Group
n=5 Participants
in which subjects will receive a glutamine drink (0.25 g/kg per dose) before breakfast and dinner (twice daily), and perform 'exercise snacks' before each meal
Glutamine vs. Placebo: oral supplementation with either glutamine or placebo twice daily for 3 months
Exercise: short bouts of exercise ('exercise snacks') 3 times daily for 3 months
|
|---|---|---|
|
Change in Percent of Blood Glucose (BG) Within Target
baseline
|
63.7 Percentage of Blood Glucose
Standard Deviation 14.5
|
57.6 Percentage of Blood Glucose
Standard Deviation 16.8
|
|
Change in Percent of Blood Glucose (BG) Within Target
at 3 months
|
46.4 Percentage of Blood Glucose
Standard Deviation 21.1
|
69.2 Percentage of Blood Glucose
Standard Deviation 18.4
|
SECONDARY outcome
Timeframe: baseline vs. at 3 monthsChange in Percent of BG below 70 mg/dL, as determined by Continuous Glucose Monitor (CGM)
Outcome measures
| Measure |
an Exercise Group
n=7 Participants
in which subjects will perform daily 'exercise snacks' within 30 min before breakfast, lunch, and/or dinner or bedtime snack, along with a placebo drink which will be given before breakfast and dinner (twice daily);
Exercise: short bouts of exercise ('exercise snacks') 3 times daily for 3 months
|
an Exercise + Glutamine Group
n=5 Participants
in which subjects will receive a glutamine drink (0.25 g/kg per dose) before breakfast and dinner (twice daily), and perform 'exercise snacks' before each meal
Glutamine vs. Placebo: oral supplementation with either glutamine or placebo twice daily for 3 months
Exercise: short bouts of exercise ('exercise snacks') 3 times daily for 3 months
|
|---|---|---|
|
Percent of BG <70 mg/dL
baseline
|
7.2 Percentage of Blood Glucose
Standard Deviation 6.0
|
3.1 Percentage of Blood Glucose
Standard Deviation 3.1
|
|
Percent of BG <70 mg/dL
at 3 months
|
7.2 Percentage of Blood Glucose
Standard Deviation 5.1
|
4.4 Percentage of Blood Glucose
Standard Deviation 2.0
|
SECONDARY outcome
Timeframe: baseline vs. at 3 monthsChange in Percent of BG above 180 mg, as determined using Continuous Glucose Monitor (CGM)
Outcome measures
| Measure |
an Exercise Group
n=7 Participants
in which subjects will perform daily 'exercise snacks' within 30 min before breakfast, lunch, and/or dinner or bedtime snack, along with a placebo drink which will be given before breakfast and dinner (twice daily);
Exercise: short bouts of exercise ('exercise snacks') 3 times daily for 3 months
|
an Exercise + Glutamine Group
n=5 Participants
in which subjects will receive a glutamine drink (0.25 g/kg per dose) before breakfast and dinner (twice daily), and perform 'exercise snacks' before each meal
Glutamine vs. Placebo: oral supplementation with either glutamine or placebo twice daily for 3 months
Exercise: short bouts of exercise ('exercise snacks') 3 times daily for 3 months
|
|---|---|---|
|
Percent Blood Glucose (BG) >180
basline
|
29.1 Percentage of Blood Glucose
Standard Deviation 15.6
|
39.4 Percentage of Blood Glucose
Standard Deviation 18.9
|
|
Percent Blood Glucose (BG) >180
at 3 months
|
46.4 Percentage of Blood Glucose
Standard Deviation 21.1
|
26.6 Percentage of Blood Glucose
Standard Deviation 17.8
|
SECONDARY outcome
Timeframe: baseline vs. at 3 monthsChange in insulin dose (Units/kg/day) used at home
Outcome measures
| Measure |
an Exercise Group
n=7 Participants
in which subjects will perform daily 'exercise snacks' within 30 min before breakfast, lunch, and/or dinner or bedtime snack, along with a placebo drink which will be given before breakfast and dinner (twice daily);
Exercise: short bouts of exercise ('exercise snacks') 3 times daily for 3 months
|
an Exercise + Glutamine Group
n=5 Participants
in which subjects will receive a glutamine drink (0.25 g/kg per dose) before breakfast and dinner (twice daily), and perform 'exercise snacks' before each meal
Glutamine vs. Placebo: oral supplementation with either glutamine or placebo twice daily for 3 months
Exercise: short bouts of exercise ('exercise snacks') 3 times daily for 3 months
|
|---|---|---|
|
Insulin Dose
baseline
|
1.0 Units/kg/day
Standard Deviation 0.2
|
0.98 Units/kg/day
Standard Deviation 0.1
|
|
Insulin Dose
at 3 months
|
0.8 Units/kg/day
Standard Deviation 0.1
|
1.0 Units/kg/day
Standard Deviation 0.4
|
SECONDARY outcome
Timeframe: baseline vs. at 3 monthsChange in insulin sensitivity score, determined using SEARCH ISS model published equation: logeIS = 4.64725 - 0.02032 × (waist, cm) - 0.09779 × (HbA1c, %) - 0.00235 × (Triglycerides, mg/dL). The range of ISS scores is between 1-15. Higher scores imply a better insulin sensistivity.
Outcome measures
| Measure |
an Exercise Group
n=7 Participants
in which subjects will perform daily 'exercise snacks' within 30 min before breakfast, lunch, and/or dinner or bedtime snack, along with a placebo drink which will be given before breakfast and dinner (twice daily);
Exercise: short bouts of exercise ('exercise snacks') 3 times daily for 3 months
|
an Exercise + Glutamine Group
n=5 Participants
in which subjects will receive a glutamine drink (0.25 g/kg per dose) before breakfast and dinner (twice daily), and perform 'exercise snacks' before each meal
Glutamine vs. Placebo: oral supplementation with either glutamine or placebo twice daily for 3 months
Exercise: short bouts of exercise ('exercise snacks') 3 times daily for 3 months
|
|---|---|---|
|
Insulin Sensitivity Score (ISS)
baseline
|
2.17 score on a scale
Standard Deviation 0.2
|
2.10 score on a scale
Standard Deviation 0.19
|
|
Insulin Sensitivity Score (ISS)
at 3 months
|
2.20 score on a scale
Standard Deviation 0.17
|
2.16 score on a scale
Standard Deviation 0.15
|
Adverse Events
an Exercise Group,
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Exercise + Glutamine Group
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