- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00071526
Urinary Vitamin C Loss in Diabetic Subjects
Urinary Vitamin C Loss in Subjects With and Without Diabetes
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Irene T Rozga, R.N.
- Phone Number: (301) 496-1069
- Email: irene.rozga@nih.gov
Study Contact Backup
- Name: Ifechukwude C Ebenuwa, M.D.
- Phone Number: (301) 435-6582
- Email: ifechukwude.ebenuwa@nih.gov
Study Locations
-
-
Maryland
-
Bethesda, Maryland, United States, 20892
- Recruiting
- National Institutes of Health Clinical Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
- INCLUSION CRITERIA:
We propose to study of five thousand male and female subjects between the ages of 18 and 65. This will include healthy subjects and subjects with type 1 or type 2 diabetes. To be included in the study, study subjects should
- be in good general health
- have no significant illnesses that compromise clinical stability other than the complications of diabetes mellitus alone or in the context of metabolic syndrome. Subjects with ischemic heart disease and/or peripheral artery disease are eligible for arm 1 of the protocol.
- have serum creatinine < 2.5
- for healthy volunteers, be normotensive at the time of the study, with a blood pressure less than or equal to 140/90
- for diabetic subjects, blood pressure less than or equal to 170/95 as long as clinically stable and in usual state of health, for example, no chest pain, shortness of breath, headache, syncope or fatigue
The aim of this study is to determine whether diabetic subjects lose vitamin C in the urine in their normal clinical condition (i.e. while on treatment) and not in the native untreated state of uncontrolled hyperglycemia. Therefore the patients will not discontinue medication.
EXCLUSION CRITERIA (for arm 1):
Exclusion criteria will include the following:
- significant organ malfunction leading to clinical instability including liver disease, pulmonary disease, stroke and anemia at investigator discretion
- serious or chronic illness or history of serious or chronic illness resulting in clinical instability other than complications of diabetes
- pregnancy
- alcohol abuse, drug addiction or the use of illegal drugs
- positive HIV or hepatitis (B or C) screening tests (subjects will be notified of these test results).
- presence of other concomitant conditions which in the judgment of the investigators can influence vitamin C metabolism or vitamin C renal handling
EXCLUSION CRITERIA (for arms 2 and 3):
Exclusion criteria will include the following:
- significant organ malfunction leading to clinical instability including liver disease, pulmonary disease, ischemic heart disease, heart failure, stroke, peripheral vascular disease, and anemia at investigator discretion
- other serious or chronic illness; history of serious or chronic illness; coronary artery disease, or peripheral vascular disease resulting in clinical instability
- pregnancy
- alcohol abuse, drug addiction or the use of illegal drugs
- positive HIV or hepatitis (B or C) screening tests (subjects will be notified of these test results).
- presence of other concomitant conditions which in the judgment of the investigators can influence vitamin C metabolism or vitamin C renal handling
For inpatient subjects, an additional exclusion criterion is consumption during the hospitalization of any foods or beverages other than those in the vitamin C free diet.
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
---|
Healthy Volunteers
|
Diabetes Type I
Subjects with Type I diabetes mellitus
|
Diabetes Type II
Subjects with Type II diabetes mellitus
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Plasma, neutrophil and RBC Vitamin C concentrates
Time Frame: end of study
|
Measurements of plasma, neutrophil and red blood cell vitamin c concentrations in diabetic subjects as compared to healthy controls.
|
end of study
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Urinary vitamin C concentration
Time Frame: end of study
|
Measurements of urinary vitamin c concentrations in diabetic subjects as compared to healthy controls.
|
end of study
|
Determine the renal threshold and relative bioavailability for vitamin C
Time Frame: end of study
|
Calculate renal threshold of vitamin C in diabetic subjects as compared to healthy controls.
|
end of study
|
Collaborators and Investigators
Investigators
- Principal Investigator: Ifechukwude C Ebenuwa, M.D., National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Publications and helpful links
General Publications
- Levine M. New concepts in the biology and biochemistry of ascorbic acid. N Engl J Med. 1986 Apr 3;314(14):892-902. doi: 10.1056/NEJM198604033141407. No abstract available.
- Goodwin JS, Goodwin JM, Garry PJ. Association between nutritional status and cognitive functioning in a healthy elderly population. JAMA. 1983 Jun 3;249(21):2917-21.
- Fata FT, Herzlich BC, Schiffman G, Ast AL. Impaired antibody responses to pneumococcal polysaccharide in elderly patients with low serum vitamin B12 levels. Ann Intern Med. 1996 Feb 1;124(3):299-304. doi: 10.7326/0003-4819-124-3-199602010-00003.
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 040021
- 04-DK-0021
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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