Glutathione Metabolism in Adolescents With Type 1 Diabetes - Study B

NCT00858273 | Completed Results

• 1 other identifier: JDRF 1-2006-627-B
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Diabetes Mellitus, Type 1

Keywords

Glutathione

Outcome Measures

Primary Outcomes (1)

• Glutathione Concentration

  While at near normoglycemia

  After 3-9 months of improved blood glucose control (HbA1c decrease of >0.5%)

Secondary Outcomes (1)

• Plasma Protein Bound 3-nitrotyrosine

  After 3-9 months of improved blood glucose control (HbA1c decrease of >0.5%)

Study Arms (2)

Antioxidant Supplement

ACTIVE COMPARATOR

Vitamin C 250 mg; beta-carotene 6 mg; vitamin E 30 mg; selenium 100 mcg; zinc 20 mg

Dietary Supplement: Antioxidant supplement; Other: Diabetes treatment; Drug: Regular Insulin

Placebo

PLACEBO COMPARATOR

Dietary Supplement: Antioxidant supplement; Other: Diabetes treatment; Drug: Regular Insulin

Interventions

Antioxidant supplement DIETARY_SUPPLEMENT

1 capsule daily with dinner

Antioxidant Supplement; Placebo

Diabetes treatment OTHER

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

Antioxidant Supplement; Placebo

Regular Insulin DRUG

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

Antioxidant Supplement; Placebo

Eligibility Criteria

• Age: 12 Years - 21 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 12-21
• 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

Related Publications (1)

• Benson M, Hossain J, Darmaun D. Improved glycemic control either alone, or combined with antioxidant supplementation, fails to restore blood glutathione or markers of oxidative stress in adolescents with poorly controlled type 1 diabetes. Nutr Res. 2023 Sep;117:83-90. doi: 10.1016/j.nutres.2023.05.010. Epub 2023 May 25.

  PMID: 37515943 DERIVED

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: Dominique Darmaun, MD
• Organization: Nemours Children's Clinic

ddarmaun@nemours.org

(904) 697 3674

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: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 6, 2009
• First Posted: March 9, 2009
• Study Start: March 1, 2008
• Primary Completion: March 1, 2011
• Study Completion: August 1, 2011
• Last Updated: May 17, 2023
• Results First Posted: May 17, 2023

Record last verified: 2012-05

Locations

US (1)