Trial Outcomes & Findings for Glutamine and Insulin Sensitivity in Type I Diabetes (NCT NCT01467063)
NCT ID: NCT01467063
Last Updated: 2021-07-14
Results Overview
Insulin sensitivity as measured by hyperinsulinemic-euglycemic clamp. Insulin sensitivity was calculated by dividing the average glucose infusion rate (mL glucose infusion/kg body weight/min) by the average insulin concentration (uU/mL).
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
13 participants
Primary outcome timeframe
During the Hyperinsulinemic-Euglycemic Clamp, an average of 3 hours
Results posted on
2021-07-14
Participant Flow
Participant milestones
| Measure |
Glutamine, Then Placebo
Thirteen subjects were recruited, 12 of 13 completed the study; 2 did not receive isotope infusions but underwent all other procedures and were included in all analyses.
|
Placebo, Then Glutamine
Thirteen subjects were recruited, 12 of 13 completed the study; 2 did not receive isotope infusions but underwent all other procedures and were included in all analyses.
|
|---|---|---|
|
Overall Study
STARTED
|
6
|
7
|
|
Overall Study
COMPLETED
|
5
|
7
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Glutamine and Insulin Sensitivity in Type I Diabetes
Baseline characteristics by cohort
| Measure |
All Participants
n=13 Participants
|
|---|---|
|
Age, Continuous
|
16 years
STANDARD_DEVIATION 2 • n=39 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=39 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=39 Participants
|
|
Region of Enrollment
United States
|
13 participants
n=39 Participants
|
PRIMARY outcome
Timeframe: During the Hyperinsulinemic-Euglycemic Clamp, an average of 3 hoursPopulation: Thirteen subjects were recruited, 12 of 13 completed the study; 2 did not receive isotope infusions but underwent all other procedures and were included in all analyses.
Insulin sensitivity as measured by hyperinsulinemic-euglycemic clamp. Insulin sensitivity was calculated by dividing the average glucose infusion rate (mL glucose infusion/kg body weight/min) by the average insulin concentration (uU/mL).
Outcome measures
| Measure |
Glutamine
n=12 Participants
Glutamine: Participants will keep a diary of food intake and activity as well as wear an accelerometer (to measure overall movement) for 2-3 days prior to the admission. Subject will come to the Clinical Research Center for approximately 24 hours. They will receive a drink containing Glutamine (0.25 g/kg/dose). Afterwards they will have an afternoon exercise session consisting of 15-min bouts of exercise, interspersed with 5-min rest periods in between for a total of 75min. Blood glucose will be checked during rest intervals. They will be served a controlled dinner. Before bedtime another dose of the same drink will be given. Overnight blood glucose will be monitored closely. In the morning, another dose of the same drink will be given. Subjects will have two isotope infusions (non-radioactive) running concomitantly and a hyperinsulinemic-euglycemic clamp will be performed. Afterwards lunch will be served and subject discharged home.
|
Placebo
n=12 Participants
Placebo: Participants will keep a diary of food intake and activity as well as wear an accelerometer (to measure overall movement) for 2-3 days prior to the admission. Subject will come to the Clinical Research Center for approximately 24 hours. They will receive a PLACEBO drink. Afterwards they will have an afternoon exercise session consisting of 15-min bouts of exercise, interspersed with 5-min rest periods in between for a total of 75min. Blood glucose will be checked during rest intervals. They will be served a controlled dinner. Before bedtime another dose of the same drink will be given. Overnight blood glucose will be monitored closely. In the morning, another dose of the same drink will be given. Subjects will have two isotope infusions (non-radioactive) running concomitantly and a hyperinsulinemic-euglycemic clamp will be performed. Afterwards lunch will be served and subject discharged home.
|
|---|---|---|
|
Insulin Sensitivity
|
0.1 mL/kg/min per uU/mL
Standard Error 0.02
|
0.07 mL/kg/min per uU/mL
Standard Error 0.02
|
SECONDARY outcome
Timeframe: Post-InfusionOutcome measures
| Measure |
Glutamine
n=12 Participants
Glutamine: Participants will keep a diary of food intake and activity as well as wear an accelerometer (to measure overall movement) for 2-3 days prior to the admission. Subject will come to the Clinical Research Center for approximately 24 hours. They will receive a drink containing Glutamine (0.25 g/kg/dose). Afterwards they will have an afternoon exercise session consisting of 15-min bouts of exercise, interspersed with 5-min rest periods in between for a total of 75min. Blood glucose will be checked during rest intervals. They will be served a controlled dinner. Before bedtime another dose of the same drink will be given. Overnight blood glucose will be monitored closely. In the morning, another dose of the same drink will be given. Subjects will have two isotope infusions (non-radioactive) running concomitantly and a hyperinsulinemic-euglycemic clamp will be performed. Afterwards lunch will be served and subject discharged home.
|
Placebo
n=12 Participants
Placebo: Participants will keep a diary of food intake and activity as well as wear an accelerometer (to measure overall movement) for 2-3 days prior to the admission. Subject will come to the Clinical Research Center for approximately 24 hours. They will receive a PLACEBO drink. Afterwards they will have an afternoon exercise session consisting of 15-min bouts of exercise, interspersed with 5-min rest periods in between for a total of 75min. Blood glucose will be checked during rest intervals. They will be served a controlled dinner. Before bedtime another dose of the same drink will be given. Overnight blood glucose will be monitored closely. In the morning, another dose of the same drink will be given. Subjects will have two isotope infusions (non-radioactive) running concomitantly and a hyperinsulinemic-euglycemic clamp will be performed. Afterwards lunch will be served and subject discharged home.
|
|---|---|---|
|
Glucagon-like Peptide 1 (GLP-1)
|
2.3 pmol/L
Standard Error 0.3
|
1.8 pmol/L
Standard Error 0.1
|
Adverse Events
Glutamine
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo
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