Trial Outcomes & Findings for Glutathione Metabolism in Adolescents With Type 1 Diabetes - Study B (NCT NCT00858273)
NCT ID: NCT00858273
Last Updated: 2023-05-17
Results Overview
While at near normoglycemia
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
41 participants
Primary outcome timeframe
After 3-9 months of improved blood glucose control (HbA1c decrease of >0.5%)
Results posted on
2023-05-17
Participant Flow
Participant milestones
| Measure |
Antioxidant Supplement
Vitamin C 250 mg; beta-carotene 6 mg; vitamin E 30 mg; selenium 100 mcg; zinc 20 mg
Antioxidant supplement: 1 capsule daily with dinner
Diabetes treatment: Intensification of diabetes treatment regimen, including education and counseling, home blood glucose monitoring, multiple daily insulin injections (MDI), diet plan, and frequent phone contact with a certified diabetes educator
Regular Insulin: Regular Insulin, IV, to maintain blood glucose in normoglycemic range (70-140) during metabolic study
|
Placebo
Antioxidant supplement: 1 capsule daily with dinner
Diabetes treatment: Intensification of diabetes treatment regimen, including education and counseling, home blood glucose monitoring, multiple daily insulin injections (MDI), diet plan, and frequent phone contact with a certified diabetes educator
Regular Insulin: Regular Insulin, IV, to maintain blood glucose in normoglycemic range (70-140) during metabolic study
|
|---|---|---|
|
Overall Study
STARTED
|
20
|
20
|
|
Overall Study
COMPLETED
|
17
|
15
|
|
Overall Study
NOT COMPLETED
|
3
|
5
|
Reasons for withdrawal
| Measure |
Antioxidant Supplement
Vitamin C 250 mg; beta-carotene 6 mg; vitamin E 30 mg; selenium 100 mcg; zinc 20 mg
Antioxidant supplement: 1 capsule daily with dinner
Diabetes treatment: Intensification of diabetes treatment regimen, including education and counseling, home blood glucose monitoring, multiple daily insulin injections (MDI), diet plan, and frequent phone contact with a certified diabetes educator
Regular Insulin: Regular Insulin, IV, to maintain blood glucose in normoglycemic range (70-140) during metabolic study
|
Placebo
Antioxidant supplement: 1 capsule daily with dinner
Diabetes treatment: Intensification of diabetes treatment regimen, including education and counseling, home blood glucose monitoring, multiple daily insulin injections (MDI), diet plan, and frequent phone contact with a certified diabetes educator
Regular Insulin: Regular Insulin, IV, to maintain blood glucose in normoglycemic range (70-140) during metabolic study
|
|---|---|---|
|
Overall Study
Protocol Violation
|
3
|
5
|
Baseline Characteristics
Glutathione Metabolism in Adolescents With Type 1 Diabetes - Study B
Baseline characteristics by cohort
| Measure |
Antioxidant Supplement
n=17 Participants
Vitamin C 250 mg; beta-carotene 6 mg; vitamin E 30 mg; selenium 100 mcg; zinc 20 mg
Antioxidant supplement: 1 capsule daily with dinner
Diabetes treatment: Intensification of diabetes treatment regimen, including education and counseling, home blood glucose monitoring, multiple daily insulin injections (MDI), diet plan, and frequent phone contact with a certified diabetes educator
Regular Insulin: Regular Insulin, IV, to maintain blood glucose in normoglycemic range (70-140) during metabolic study
|
Placebo
n=15 Participants
Antioxidant supplement: 1 capsule daily with dinner
Diabetes treatment: Intensification of diabetes treatment regimen, including education and counseling, home blood glucose monitoring, multiple daily insulin injections (MDI), diet plan, and frequent phone contact with a certified diabetes educator
Regular Insulin: Regular Insulin, IV, to maintain blood glucose in normoglycemic range (70-140) during metabolic study
|
Total
n=32 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
17 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
15.7 years
STANDARD_DEVIATION 2.3 • n=5 Participants
|
15.8 years
STANDARD_DEVIATION 2.6 • n=7 Participants
|
15.8 years
STANDARD_DEVIATION 2.4 • n=5 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
17 participants
n=5 Participants
|
15 participants
n=7 Participants
|
32 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: After 3-9 months of improved blood glucose control (HbA1c decrease of >0.5%)While at near normoglycemia
Outcome measures
| Measure |
Antioxidant Supplement
n=17 Participants
Vitamin C 250 mg; beta-carotene 6 mg; vitamin E 30 mg; selenium 100 mcg; zinc 20 mg
Antioxidant supplement: 1 capsule daily with dinner
Diabetes treatment: Intensification of diabetes treatment regimen, including education and counseling, home blood glucose monitoring, multiple daily insulin injections (MDI), diet plan, and frequent phone contact with a certified diabetes educator
Regular Insulin: Regular Insulin, IV, to maintain blood glucose in normoglycemic range (70-140) during metabolic study
|
Placebo
n=15 Participants
Antioxidant supplement: 1 capsule daily with dinner
Diabetes treatment: Intensification of diabetes treatment regimen, including education and counseling, home blood glucose monitoring, multiple daily insulin injections (MDI), diet plan, and frequent phone contact with a certified diabetes educator
Regular Insulin: Regular Insulin, IV, to maintain blood glucose in normoglycemic range (70-140) during metabolic study
|
|---|---|---|
|
Glutathione Concentration
|
706 umol/L
Standard Deviation 236
|
734 umol/L
Standard Deviation 215
|
SECONDARY outcome
Timeframe: After 3-9 months of improved blood glucose control (HbA1c decrease of >0.5%)Marker of oxidative stress
Outcome measures
| Measure |
Antioxidant Supplement
n=17 Participants
Vitamin C 250 mg; beta-carotene 6 mg; vitamin E 30 mg; selenium 100 mcg; zinc 20 mg
Antioxidant supplement: 1 capsule daily with dinner
Diabetes treatment: Intensification of diabetes treatment regimen, including education and counseling, home blood glucose monitoring, multiple daily insulin injections (MDI), diet plan, and frequent phone contact with a certified diabetes educator
Regular Insulin: Regular Insulin, IV, to maintain blood glucose in normoglycemic range (70-140) during metabolic study
|
Placebo
n=15 Participants
Antioxidant supplement: 1 capsule daily with dinner
Diabetes treatment: Intensification of diabetes treatment regimen, including education and counseling, home blood glucose monitoring, multiple daily insulin injections (MDI), diet plan, and frequent phone contact with a certified diabetes educator
Regular Insulin: Regular Insulin, IV, to maintain blood glucose in normoglycemic range (70-140) during metabolic study
|
|---|---|---|
|
Plasma Protein Bound 3-nitrotyrosine
|
4.26 ng/mL
Interval 1.65 to 19.0
|
7.13 ng/mL
Interval 1.22 to 10.9
|
Adverse Events
Antioxidant Supplement
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