No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Healthy Volunteers Welcome
You do not need to have the condition being studied to take part.
No Study Drug
Researchers observe your health over time — no experimental treatment is given.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 – 65
Sex
Any
Study type
Observational
Participants needed
5,000 (estimated)
Sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) · NIH
Who this trial is looking for
This trial is looking for people between 18 and 65 years old who either have diabetes or do not have diabetes. Participants will undergo tests to measure their vitamin C levels in the blood and urine.
Are You a Good Fit for This Trial?
You may be able to join if
I am between 18 and 65 years old.
I have been diagnosed with Type 1 or Type 2 diabetes.
I do not have diabetes.
You may not be able to join if
I cannot provide a signed consent form.
I have significant organ problems like liver or heart disease.
I am pregnant or breastfeeding.
I have a serious or chronic illness that affects my health.
I have been advised against participation by my doctor.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
Several studies have reported that diabetic subjects have lower plasma vitamin C concentrations than non-diabetic subjects. Although urinary vitamin C loss in diabetic subjects was reported to be increased in two studies, these are difficult to interpret due to lack of controlled vitamin C intake, inadequate sampling, lack of control subjects, or methodology uncertainties in vitamin C assay and sa…
Several studies have reported that diabetic subjects have lower plasma vitamin C concentrations than non-diabetic subjects. Although urinary vitamin C loss in diabetic subjects was reported to be increased in two studies, these are difficult to interpret due to lack of controlled vitamin C intake, inadequate sampling, lack of control subjects, or methodology uncertainties in vitamin C assay and sample processing. Consequently, it is unclear whether diabetic subjects truly have both low plasma and high urine vitamin C concentrations. We propose that low plasma vitamin C concentrations in diabetic subjects are due in part to inappropriate renal loss of vitamin C in these subjects but not in healthy controls. We will study nondiabetic controls and cohorts with diabetes. Vitamin C concentrations in plasma, RBCs, and urine will be measured in outpatients. In those willing to be admitted to the Clinical Center, we will measure vitamin C pharmacokinetics to determine the relative bioavailability for vitamin C in individuals with and without abnormal urinary loss of vitamin C (or renal leak). Single nucleotide polymorphisms (SNPs) will be determined in genomic DNA responsible for the two proteins mediating sodium dependent vitamin C transport, SVCT1 and SVCT2. We will also explore mechanisms underlying abnormal urinary vitamin C loss....
Trial Locations
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Eligibility Criteria
* INCLUSION CRITERIA:
To be included in the study, study subjects should be:
* Aged 18-65 years.
* Either:
* Have no diagnosis of diabetes: "nondiabetic controls", or
* Have a diagnosis in their medical history of either Type 1 or Type 2 diabetes
EXCLUSION CRITERIA (for outpatient study, arm…
* INCLUSION CRITERIA:
To be included in the study, study subjects should be:
* Aged 18-65 years.
* Either:
* Have no diagnosis of diabetes: "nondiabetic controls", or
* Have a diagnosis in their medical history of either Type 1 or Type 2 diabetes
EXCLUSION CRITERIA (for outpatient study, arm 1)
Exclusion criteria will include the following:
* Unable or unwilling to provide a signed and dated informed consent form
* Unable or unwilling to comply with study procedures and lifestyle considerations
EXCLUSION CRITERIA (for inpatient studies, arms 2 and 3)
Study participants interested in participating in Arms 2 and/or 3 will be excluded from this further participation if they meet any of 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 or lactation
* presence of other conditions which, in the judgment of the investigators, can influence vitamin C metabolism or vitamin C renal handling
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