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Quantitative in Vivo Biomarkers of Oxidative Stress in Diabetes

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ClinicalTrials.gov Identifier: NCT00845130
Recruitment Status : Active, not recruiting
First Posted : February 18, 2009
Results First Posted : July 21, 2016
Last Update Posted : March 20, 2017
Information provided by (Responsible Party):
In-Young Choi, Ph.D., University of Kansas Medical Center

Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Other
Conditions: Type 2 Diabetes
Oxidative Stress
Intervention: Biological: ascorbic acid (Vitamin C)

  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
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 

  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
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 
[Units: Participants]
Count of Participants
<=18 years      0   0.0%      0   0.0%      0   0.0% 
Between 18 and 65 years      16 100.0%      19 100.0%      35 100.0% 
>=65 years      0   0.0%      0   0.0%      0   0.0% 
[Units: Years]
Mean (Standard Deviation)
 48  (5)   45  (7)   47  (6) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
Female      7  43.8%      12  63.2%      19  54.3% 
Male      9  56.3%      7  36.8%      16  45.7% 
Region of Enrollment 
[Units: Participants]
United States   16   19   35 

  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

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

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
ClinicalTrials.gov Identifier: NCT00845130     History of Changes
Other Study ID Numbers: 11119
First Submitted: February 15, 2009
First Posted: February 18, 2009
Results First Submitted: June 9, 2016
Results First Posted: July 21, 2016
Last Update Posted: March 20, 2017