- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01415115
Using SCOUT Noninvasive AGE Measurements to Forecast Diabetes Complications (MARC)
A Cross-Sectional Study to Test the Feasibility of Using SCOUT Noninvasive AGE Measurements to Forecast Diabetes Complications
Study Overview
Status
Conditions
Detailed Description
Diabetes mellitus is a major health problem in the United States and throughout the world's developed and developing nations. In 2002, the American Diabetes Association (ADA) has estimated that 12.1 million Americans (4.2%) had been diagnosed with some form of diabetes [1], and the World Health Organization (WHO) assessed the global diabetes caseload at 173 million in the year 2000 [2]. While type 1 patients comprise approximately 5 -10% of the US cases [3], the severe morbidity in those patients including renal failure, blindness, neuropathy and micro- and macro-vascular disease motivate the search for improved techniques for monitoring disease status.
Diabetes is devastating to individual health and has a significant impact on the national economy. In 2002, US economic impact related to diabetes exceeded $132 billion. Due to the numerous complications that result from chronic hyperglycemia a wide array of health services are involved. For example, between 5 and 20 percent of all US services in the areas of cardiovascular disease, kidney disease, endocrine and metabolic complications, and ophthalmic disorders are attributable to diabetes.
Landmark clinical trials in the US and UK have established that tight glucose control via a regimen of glucose monitoring, insulin and/or sulfonylurea or other drug therapy, exercise, and proper diet significantly reduces the progression of, and risk for, developing diabetic complications [4, 5]. Long-term, chronic hyperglycemia is recognized as the initiator of debilitating diabetes-related complications such as blindness, kidney failure and nerve damage [6]. Hence, an effective monitor for overall glycemic control should reflect the long-term, integrated glycemic insult to the body.
One concept of a monitor for long-term glycemic control involves the measurement of an analyte whose concentration monotonically increases over the course of disease progression. Such a chemical marker would not vary with the state in which the patient presented on the day of the test. The process of protein glycation (or 'browning'), governed by the Maillard reaction, produces several advanced glycation endproducts that are attractive candidates for such a 'diabetes meter.' These compounds are currently assayed by invasive procedures, requiring a biopsy specimen, but, based upon initial results with the VeraLight SCOUT, they are also accessible by noninvasive monitoring.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Maryland
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Hyattsville, Maryland, United States, 20783
- MedStar Health Research Institute
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Potential subjects for the study will have type 1 or type 2 diabetes. Patients presenting for their periodic examinations at his practice will be given the opportunity to participate. Enrollment will conclude when the target of 250 subjects have been examined.
Exclusion Criteria:
- Wounds or injuries on the volar forearm in the field of view of SCOUT including blisters, cuts, scabs, cracked skin, tattoos and bleeding or oozing skin
- Rash on forearm in field of SCOUT scan including eczema, psoriasis, shingles, rosacea, swimmer's itch, Christmas tree rash, lichen planus, contact dermatitus, ringworm, heat rash or drug rash
- Receiving other investigational treatments
- Receiving medications that may alter skin fluorescence/photosensitivity, including Doxorubicin, Daunomycin, Camptothecin, Protoporphyrin, Fluoroquinolones, Tetracycline and/or Quinidine
- Known to be pregnant
- Prisoner, mentally incompetent or unable to follow study procedures
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Type 1 Diabetes
Must have been diagnosed with type 1 diabetes.
Subject group will be measured on SCOUT and compared to Type 2 diabetes cohort.
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Type 2 Diabetes
Must have been diagnosed with Type 2 diabetes.
This group will be compared to the Type 1 cohort.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
SCOUT Comparison
Time Frame: 1 day
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This cross-sectional study will test the hypothesis that the correlation between quantitative measurements of skin AGEs by SCOUT noninvasive fluorescence technique, and aggregate diabetic complications, is statistically equivalent to the correlation between the aggregate complications and either disease duration, concurrent HbA1c or individual complications (retinopathy, nephropathy, neuropathy, hypertension and dyslipidemia).
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1 day
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Hypertension
Time Frame: 1 Day
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Five categories of complications--hypertension, dyslipidemia, renal function, retinopathy and neuropathy--will be quantified.
Hypertension will be staged based upon blood pressure measurements.
The hypertension quantification will follow the classification scheme published by Joint National Committee on Prevention Detection, Evaluation, and Treatment of High Blood Pressure.
Dyslipidemia will be quantified by mean plasma lipid values.
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1 Day
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Robert Ratner, MD, Medstar
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- VL-2702
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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