Trial Outcomes & Findings for Glutathione Metabolism in Adolescents With Type 1 Diabetes - Study A (NCT NCT00858897)
NCT ID: NCT00858897
Last Updated: 2023-07-10
Results Overview
umol/L
COMPLETED
NA
10 participants
Up to 30 minutes post- 5 hour infusion on Day 1 (First Intervention) and up to 30 minutes post- 5 hour infusion on Day 14 (Second Intervention)
2023-07-10
Participant Flow
Each of the 10 Subjects received two 5-hour intravenous infusions of L-\[3,3-2H2\]cysteine in the postabsorptive state on 2 separate days after blood glucose had been maintained overnight at normoglycemia or hyperglycemia, using intravenous insulin infusion. The order of the normo- and hyper-glycemia study days was randomized.
Participant milestones
| Measure |
Normoglycemia (80-140 mg/dL), Then Hyperglycemia (200-250 mg/dL)
Cysteine isotope infusion at normoglycemia vs hyperglycemia: L-\[3,3-2H2\]cysteine on 2 separate days, in randomized order
Regular Insulin: Regular insulin, IV, as needed to maintain blood glucose in near-normoglycemic range (80-140 mg/dL) during metabolic studies
|
Hyperglycemia (200-250 mg/dL), Then Normoglycemia (80-140 mg/dL)
Cysteine isotope infusion at normoglycemia vs hyperglycemia: L-\[3,3-2H2\]cysteine on 2 separate days, in randomized order
Regular Insulin: Regular insulin, IV, as needed to maintain blood glucose in near-normoglycemic range (80-140 mg/dL) during metabolic studies
|
|---|---|---|
|
First Intervention (1 Day)
STARTED
|
4
|
6
|
|
First Intervention (1 Day)
COMPLETED
|
4
|
6
|
|
First Intervention (1 Day)
NOT COMPLETED
|
0
|
0
|
|
Washout (~9 Days)
STARTED
|
4
|
6
|
|
Washout (~9 Days)
COMPLETED
|
4
|
6
|
|
Washout (~9 Days)
NOT COMPLETED
|
0
|
0
|
|
2nd Intervention (1 Day)
STARTED
|
4
|
6
|
|
2nd Intervention (1 Day)
COMPLETED
|
4
|
6
|
|
2nd Intervention (1 Day)
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Glutathione Metabolism in Adolescents With Type 1 Diabetes - Study A
Baseline characteristics by cohort
| Measure |
All Subjects Enrolled
n=10 Participants
Adolescents with Type 1 Diabetes
|
|---|---|
|
Age, Categorical
<=18 years
|
10 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
16.9 years
STANDARD_DEVIATION 1.5 • n=5 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
10 participants
n=5 Participants
|
|
HbA1C
|
9.2 percent of total hemoglobin
STANDARD_DEVIATION 0.5 • n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 30 minutes post- 5 hour infusion on Day 1 (First Intervention) and up to 30 minutes post- 5 hour infusion on Day 14 (Second Intervention)Population: Each of the 10 Subjects received two 5-hour intravenous infusions of L-\[3,3-2H2\]cysteine in the postabsorptive state on 2 separate days after blood glucose had been maintained overnight at normoglycemia or hyperglycemia, using intravenous insulin infusion.
umol/L
Outcome measures
| Measure |
Normoglycemia (80-140 mg/dL)
n=10 Participants
Cysteine isotope infusion at normoglycemia vs hyperglycemia: L-\[3,3-2H2\]cysteine
Regular Insulin: Regular insulin, IV, as needed to maintain blood glucose in near-normoglycemic range (80-140 mg/dL) or hyperglycemic range (200-250 mg/mL) during metabolic studies
|
Hyperglycemia (200-250 mg/dL)
n=10 Participants
Cysteine isotope infusion at normoglycemia vs hyperglycemia: L-\[3,3-2H2\]cysteine
Regular Insulin: Regular insulin, IV, as needed to maintain blood glucose in near-normoglycemic range (80-140 mg/dL) or hyperglycemic range (200-250 mg/mL) during metabolic studies
|
|---|---|---|
|
Glutathione Concentration
|
541 umol/L
Standard Error 232
|
551 umol/L
Standard Error 169
|
Adverse Events
Normoglycemia (80-140 mg/dL)
Hyperglycemia (200-250 mg/dL)
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