NCT00775541

Brief Summary

The purpose of this study is to use an MRI exam to measure the concentrations of glutathione (GSH) and Vitamin C (Asc) in the brains of normal healthy persons and type 2 diabetic persons. The study will look at the relationship between chronic hyperglycemia and the levels of these naturally occurring chemicals in the brain.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5

participants targeted

Target at below P25 for not_applicable type-2-diabetes

Timeline
Completed

Started Oct 2007

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2007

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

October 17, 2008

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 20, 2008

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2009

Completed
Last Updated

June 18, 2012

Status Verified

June 1, 2012

Enrollment Period

1.8 years

First QC Date

October 17, 2008

Last Update Submit

June 15, 2012

Conditions

Type 2 Diabetes

Keywords

DiabetesType 2 Diabetes

Outcome Measures

Primary Outcomes (1)

  • MRI, mRS, urine and blood samples

    before and after IV infusion, 6 hours

Secondary Outcomes (1)

  • 7 day food and DHQ food questionnaire

    7 days prior to MRI and vitamin C infusion

Study Arms (1)

Vitamin C

EXPERIMENTAL

2 gms vitamin C

Dietary Supplement: Vitamin C

Interventions

Vitamin CDIETARY_SUPPLEMENT

One IV infusion of 2 gm vitamin C

Vitamin C

Eligibility Criteria

Age30 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Good health except for having type 2 diabetes
  • Being treated with diet, insulin, or oral hyperglycemic agents
  • Male or non pregnant female
  • Non-smoker
  • HbA1c 8 or above
  • Able to provide informed consent

You may not qualify if:

  • Presence of mental illness
  • Co-existing chronic inflammatory condition or neurological disease or diseases associated with abnormal glutathione metabolism
  • BMI over 35
  • Smoker

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Diabetes Mellitus

Interventions

Ascorbic Acid

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Sugar AcidsAcids, AcyclicCarboxylic AcidsOrganic ChemicalsHydroxy AcidsCarbohydrates

Study Officials

  • In-Young Choi, PhD

    University of Kansas Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

October 17, 2008

First Posted

October 20, 2008

Study Start

October 1, 2007

Primary Completion

August 1, 2009

Study Completion

August 1, 2009

Last Updated

June 18, 2012

Record last verified: 2012-06

Locations

US(1)