Trial Outcomes & Findings for Quantitative in Vivo Biomarkers of Oxidative Stress in Diabetes (NCT NCT00845130)

Results Overview

Concentrations of vitamin C were measured in the brains of type 2 Diabetic patients and healthy controls.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

42 participants

Primary outcome timeframe

Pre-Vitamin C infusion

Results posted on

2018-05-03

Participant Flow

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.

Participant milestones

Participant milestones
Measure	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).
Overall Study STARTED	20	22
Overall Study COMPLETED	16	19
Overall Study NOT COMPLETED	4	3

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Quantitative in Vivo Biomarkers of Oxidative Stress in Diabetes

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Diabetic Type II Subjects n=16 Participants Subjects received ascorbic acid (Vitamin C) infusion 1 g/kg (maximum 100gm).	Health Subjects n=19 Participants Subjects received ascorbic acid (Vitamin C) infusion 1 g/kg (maximum 100gm).	Total n=35 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	16 Participants n=5 Participants	19 Participants n=7 Participants	35 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	48 years STANDARD_DEVIATION 5 • n=5 Participants	45 years STANDARD_DEVIATION 7 • n=7 Participants	47 years STANDARD_DEVIATION 6 • n=5 Participants
Sex: Female, Male Female	7 Participants n=5 Participants	12 Participants n=7 Participants	19 Participants n=5 Participants
Sex: Female, Male Male	9 Participants n=5 Participants	7 Participants n=7 Participants	16 Participants n=5 Participants
Region of Enrollment United States	16 participants n=5 Participants	19 participants n=7 Participants	35 participants n=5 Participants

PRIMARY outcome

Timeframe: Pre-Vitamin C infusion

Population: Determine cerebral concentrations of vitamin C. Data from one healthy subject were not usable due to subject's movement during MRI scan.

Concentrations of vitamin C were measured in the brains of type 2 Diabetic patients and healthy controls.

Outcome measures

Outcome measures
Measure	Diabetic Type II Subjects n=16 Participants Vitamin C level in the living brain	Healthy Subjects n=18 Participants Vitamin C levels in the living brain.
Concentration of Vitamin C in Type 2 Diabetic Patients.	1.1 umol/g tissue Standard Deviation 0.2	1.2 umol/g tissue Standard Deviation 0.1

PRIMARY outcome

Timeframe: 2 hour post infusion

Population: Data from one healthy subject were not usable due to subject's movement during MRI scan.

Concentrations of vitamin C after IV infusion of Vitamin C were measured in the brains of patients with type 2 diabetes and healthy controls to examine whether the concentrations are different between two groups.

Outcome measures

Outcome measures
Measure	Diabetic Type II Subjects n=16 Participants Vitamin C level in the living brain	Healthy Subjects n=18 Participants Vitamin C levels in the living brain.
Quantify the Effect of Chronic Hyperglycemia on Cellular Uptake of Vitamin C Across the Blood-brain Barrier	1.1 µmol/g tissue Standard Deviation 0.2	1.4 µmol/g tissue Standard Deviation 0.2

Adverse Events

Diabetic Type II Subjects

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Healthy Subjects

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

In-Young Choi, Ph.D.

Univeristy of Kansas Medical Center

Phone: 913-588-0174

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place