Glutathione Metabolism in Adolescents With Type 1 Diabetes - Study A

NCT00858897 | Completed Results

• 1 other identifier: JDRF 1-2006-627-A
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Diabetes Mellitus, Type 1

Keywords

Glutathione

Outcome Measures

Primary Outcomes (1)

• Glutathione Concentration

  umol/L

  Up to 30 minutes post- 5 hour infusion on Day 1 (First Intervention) and up to 30 minutes post- 5 hour infusion on Day 14 (Second Intervention)

Study Arms (2)

Normoglycemia

EXPERIMENTAL

80-140 mg/dL

Other: Cysteine isotope infusion at normoglycemia vs hyperglycemia; Drug: Regular Insulin

Hyperglycemia

EXPERIMENTAL

200-250 mg/dL

Other: Cysteine isotope infusion at normoglycemia vs hyperglycemia; Drug: Regular Insulin

Interventions

Cysteine isotope infusion at normoglycemia vs hyperglycemia OTHER

L-\[3,3-2H2\]cysteine

Hyperglycemia; Normoglycemia

Regular Insulin DRUG

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

Hyperglycemia; Normoglycemia

Eligibility Criteria

• Age: 14 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Nemours Children's Clinic: lead
• Juvenile Diabetes Research Foundation: collaborator

Study Sites (1)

Nemours Children's Clinic

Jacksonville, Florida, 32207, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

Insulin

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Proinsulin; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Results Point of Contact

• Title: Dr. Dominique Darmaun
• Organization: Nemours Children's Clinic

ddarmaun@nemours.org

904-697-3863

Study Officials

• Dominique Darmaun, MD, PhD

  Nemours Children's Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physician

Study Record Dates

• First Submitted: March 6, 2009
• First Posted: March 10, 2009
• Study Start: June 1, 2007
• Primary Completion: February 1, 2008
• Study Completion: February 1, 2009
• Last Updated: July 10, 2023
• Results First Posted: July 10, 2023

Record last verified: 2023-06

Locations

US (1)