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Glutathione Metabolism in Adolescents With Type 1 Diabetes - Study A

This study has been completed.
Sponsor:
Collaborator:
Juvenile Diabetes Research Foundation
Information provided by:
Nemours Children's Clinic
ClinicalTrials.gov Identifier:
NCT00858897
First received: March 6, 2009
Last updated: July 14, 2009
Last verified: July 2009
History of Changes
  Purpose

Glutathione is normally present at high (millimolar) levels in blood and plays an important role in the body's defense against oxidative stress, that is, against the damage caused to the body by 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 blood depends on the balance between its rate of synthesis and its rate of use.

In earlier studies, the investigators found that in poorly controlled diabetic teenagers, glutathione was low, not because its production was decreased, but because it was used at an excessive rate. In this study, the investigators want to determine how short-term changes in blood sugar levels affect glutathione levels. This will help improve our understanding of how diabetes affects metabolism.


Condition Intervention
Diabetes Mellitus, Type 1
 Other: Cysteine isotope infusion at normoglycemia vs hyperglycemia
Drug: Regular Insulin

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Regulation of Glutathione Homeostasis in Adolescents With Type 1 Diabetes - Study A

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Nemours Children's Clinic:

Primary Outcome Measures:
  • Increase in glutathione concentration under normoglycemia [ Time Frame: Hyperglycemic study day vs. Normoglycemic study day, 1-2 weeks apart ] [ Designated as safety issue: No ]

Enrollment: 10
Study Start Date: June 2007
Study Completion Date: February 2009
Primary Completion Date: February 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Normoglycemia (80-140 mg/dL)
 Other: Cysteine isotope infusion at normoglycemia vs hyperglycemia
L-[3,3-2H2]cysteine
Drug: 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
Experimental: 2
Hyperglycemia (200-250 mg/dL)
 Other: Cysteine isotope infusion at normoglycemia vs hyperglycemia
L-[3,3-2H2]cysteine
Drug: 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

Detailed Description:

Adolescents with uncomplicated T1D will receive two, 5-hour infusions of deuterium-labeled cysteine on 2 separate days, a few weeks apart, while blood glucose will be maintained, using intravenous insulin infusion:

  • in the hyper-glycemic range (200-250 mg/dL) on one study day, and
  • near normoglycemia (80-140 mg/dL) on the other study day.

The order of the study days will be randomized.

We will determine whether the level of blood glucose at the time of study affects blood glutathione concentration, and, if so, whether this is associated with changes in the fractional rate of glutathione synthesis, as determined from the incorporation of labeled cysteine into blood glutathione over the course of the 5-hr infusion of labeled cysteine.

  Eligibility

Ages Eligible for Study:   14 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Type 1 diabetes, using usual criteria such as: glycosuria, hyperglycemia prior to treatment
  • BMI <25 kg/m2
  • Age 14-18
  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00858897

Locations
United States, Florida
Nemours Children's Clinic
Jacksonville, Florida, United States, 32207
Sponsors and Collaborators
Nemours Children's Clinic
Juvenile Diabetes Research Foundation
Investigators
Principal Investigator: Dominique Darmaun, MD, PhD Nemours Children's Clinic
  More Information

No publications provided

Responsible Party: Dominique Darmaun, MD, PhD, Nemours Children's Clinic
ClinicalTrials.gov Identifier: NCT00858897     History of Changes
Other Study ID Numbers: JDRF 1-2006-627-A
Study First Received: March 6, 2009
Last Updated: July 14, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by Nemours Children's Clinic:
Glutathione

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
 Immune System Diseases
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 19, 2013