Glutathione Metabolism in Adolescents With Type 1 Diabetes - Study B

Diabetes Mellitus, Type 1 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00858273
• Other study ID #: JDRF 1-2006-627-B
• Status: Completed
• Phase: N/A
• Start date: March 2008
• Est. completion date: August 2011

Study information

• Verified date: May 2012
• Source: Nemours Children's Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

Forty adolescents with T1D will undergo a measurement of blood glutathione concentration and markers of oxidative stress (plasma protein-bound 3-nitrotyrosine, and urinary 8OH-2-dG, and F2-isoprostane excretion, markers of oxidative damage to protein, DNA and lipids, respectively) while at near normoglycemia, on two separate occasions:

• first, when in poor glucose control (HbA1c>7.5%); and

• secondly, after 3 to 9 months months of improved blood glucose control, along with the administration of either a placebo, or a mixture of antioxidant minerals and vitamins based on a randomization scheme.

Between the two metabolic study days, patients will receive the same intensified diabetes regimen consisting of education and counseling, home blood glucose monitoring, multiple daily insulin injections (MDI), diet plan, and frequent phone contact with a certified diabetes educator.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: August 2011
• Est. primary completion date: March 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 21 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1

Intervention

Dietary Supplement:
• Antioxidant supplement
1 capsule daily with dinner

Other:
• 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

Drug:
• Regular Insulin
Regular Insulin, IV, to maintain blood glucose in normoglycemic range (70-140) during metabolic study

Locations

Country	Name	City	State
United States	Nemours Children's Clinic	Jacksonville	Florida

Sponsors (2)

Lead Sponsor	Collaborator
Nemours Children's Clinic	Juvenile Diabetes Research Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Glutathione Concentration	While at near normoglycemia	After 3-9 months of improved blood glucose control (HbA1c decrease of >0.5%)
Secondary	Plasma Protein Bound 3-nitrotyrosine	Marker of oxidative stress	After 3-9 months of improved blood glucose control (HbA1c decrease of >0.5%)