Clinical trial

Regulation of Glutathione Homeostasis in Adolescents With Type 1 Diabetes - Study B

Name
JDRF 1-2006-627-B
Description
Glutathione is normally present at high levels in the blood and plays an important role in the body's defense against oxidative stress, that is, against the damage caused to the body by several reactive oxygen species produced by the metabolism of most nutrients, including glucose. Glutathione is a small peptide made from 3 amino acids, glutamate, cysteine, and glycine. This study is looking at how blood sugar levels may affect the way glutathione is made and used by the body. Since glutathione is continuously synthesized and broken down, the amount of glutathione present in the blood depends on the balance between its rate of synthesis and its rate of use. In earlier studies, we found that in poorly controlled diabetic teenagers, glutathione was low, not because it was not produced fast enough, but because it was used at an excessive rate. In this study, we want to find out whether improving blood sugar control will increase glutathione levels, and, if so, how long this will take. We also hope to find out if oral supplementation with a mixture of several antioxidant vitamins and minerals will increase glutathione levels more than taking a placebo.
Trial arms
Trial start
2008-03-01
Estimated PCD
2011-03-01
Trial end
2011-08-01
Status
Completed
Treatment
Antioxidant supplement
1 capsule daily with dinner
Arms:
Antioxidant Supplement, Placebo
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
Arms:
Antioxidant Supplement, Placebo
Regular Insulin
Regular Insulin, IV, to maintain blood glucose in normoglycemic range (70-140) during metabolic study
Arms:
Antioxidant Supplement, Placebo
Size
41
Primary endpoint
Glutathione Concentration
After 3-9 months of improved blood glucose control (HbA1c decrease of >0.5%)
Eligibility criteria
Inclusion Criteria: * Type 1 diabetes, using usual criteria such as: glycosuria, hyperglycemia prior to treatment * BMI \<25 kg/m2 * Age 12-21 * HbA1c\>7.5% * No evidence of diabetic complications * Written informed consent from parents or legal guardian, and assent from patient Exclusion Criteria: * Presence of significant anemia (hemoglobin \<11g/dL) * Presence of intercurrent illness such as infection * Presence of chronic disease such as other endocrine deficiency, chronic respiratory or cardiac disease * Chronic use of medication other than insulin * Use of vitamin or mineral supplements within 2 weeks of study
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'BASIC_SCIENCE', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 41, 'type': 'ACTUAL'}}
Updated at
2023-05-17

1 organization

1 product

2 indications

Indication
Type 1