We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Glutathione Metabolism in Adolescents With Type 1 Diabetes - Study A

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00858897
First Posted: March 10, 2009
Last Update Posted: July 15, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Juvenile Diabetes Research Foundation
Information provided by:
Nemours Children's Clinic
  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: None (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:


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 ]

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   14 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Submitted: March 6, 2009
First Posted: March 10, 2009
Last Update Posted: July 15, 2009
Last Verified: July 2009

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, Globin Zinc
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs