Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

Quantitative in Vivo Biomarkers of Oxidative Stress in Diabetes

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
In-Young Choi, Ph.D., University of Kansas Medical Center Research Institute
ClinicalTrials.gov Identifier:
NCT00845130
First received: February 15, 2009
Last updated: July 26, 2016
Last verified: July 2016
Results First Received: June 9, 2016  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: Open Label
Conditions: Type 2 Diabetes
Oxidative Stress
Intervention: Biological: ascorbic acid (Vitamin C)

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
All subjects were consented to participate in the study. After baseline information was gathered from labs, it was determined that seven subjects did not meet the inclusion criteria. They were excluded from completing the study.

Reporting Groups
  Description
Diabetic Type II Subjects Subjects received ascorbic acid (Vitamin C) infusion 1 g/kg (maximum 100gm).
Healthy Subjects Subjects received ascorbic acid (Vitamin C) infusion 1 g/kg (maximum 100gm).

Participant Flow:   Overall Study
    Diabetic Type II Subjects   Healthy Subjects
STARTED   20   22 
COMPLETED   16   19 
NOT COMPLETED   4   3 



  Baseline Characteristics
  Hide Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Diabetic Type II Subjects Subjects received ascorbic acid (Vitamin C) infusion 1 g/kg (maximum 100gm).
Health Subjects Subjects received ascorbic acid (Vitamin C) infusion 1 g/kg (maximum 100gm).
Total Total of all reporting groups

Baseline Measures
   Diabetic Type II Subjects   Health Subjects   Total 
Overall Participants Analyzed 
[Units: Participants]
 16   19   35 
Age 
[Units: Participants]
     
<=18 years   0   0   0 
Between 18 and 65 years   16   19   35 
>=65 years   0   0   0 
Age 
[Units: Years]
Mean (Standard Deviation)
 48  (5)   45  (7)   47  (6) 
Gender 
[Units: Participants]
     
Female   7   12   19 
Male   9   7   16 
Region of Enrollment 
[Units: Participants]
     
United States   16   19   35 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Concentration of Vitamin C in Type 2 Diabetic Patients.   [ Time Frame: Pre-Vitamin C infusion ]

2.  Primary:   Quantify the Effect of Chronic Hyperglycemia on Cellular Uptake of Vitamin C Across the Blood-brain Barrier   [ Time Frame: 2 hour post infusion ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
  Hide More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: In-Young Choi, Ph.D.
Organization: Univeristy of Kansas Medical Center
phone: 913-588-0174
e-mail: ichoi@kumc.edu



Responsible Party: In-Young Choi, Ph.D., University of Kansas Medical Center Research Institute
ClinicalTrials.gov Identifier: NCT00845130     History of Changes
Other Study ID Numbers: 11119
Study First Received: February 15, 2009
Results First Received: June 9, 2016
Last Updated: July 26, 2016
Health Authority: United States: Food and Drug Administration