Glutathione Metabolism in Adolescents With Type 1 Diabetes - Study B

April 24, 2023 updated by: Nemours Children's Clinic

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

41

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Jacksonville, Florida, United States, 32207
        • Nemours Children's Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

8 years to 17 years (Child, Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
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
Active Comparator: Antioxidant Supplement
Vitamin C 250 mg; beta-carotene 6 mg; vitamin E 30 mg; selenium 100 mcg; zinc 20 mg
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Glutathione Concentration
Time Frame: After 3-9 months of improved blood glucose control (HbA1c decrease of >0.5%)
While at near normoglycemia
After 3-9 months of improved blood glucose control (HbA1c decrease of >0.5%)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Plasma Protein Bound 3-nitrotyrosine
Time Frame: After 3-9 months of improved blood glucose control (HbA1c decrease of >0.5%)
Marker of oxidative stress
After 3-9 months of improved blood glucose control (HbA1c decrease of >0.5%)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nemours Children's Clinic

Collaborators

Juvenile Diabetes Research Foundation

Investigators

  • Principal Investigator: Dominique Darmaun, MD, PhD, Nemours Children's Clinic

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2008

Primary Completion (Actual)

March 1, 2011

Study Completion (Actual)

August 1, 2011

Study Registration Dates

First Submitted

March 6, 2009

First Submitted That Met QC Criteria

March 6, 2009

First Posted (Estimate)

March 9, 2009

Study Record Updates

Last Update Posted (Actual)

May 17, 2023

Last Update Submitted That Met QC Criteria

April 24, 2023

Last Verified

May 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • JDRF 1-2006-627-B

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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