Type 2 Diabetes Clinical Trial
— MARCOfficial title:
A Cross-Sectional Study to Test the Feasibility of Using SCOUT Noninvasive AGE Measurements to Forecast Diabetes Complications
Verified date | August 2011 |
Source | VeraLight, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Observational |
The trial is designed as a feasibility study to determine the correlation of noninvasive measurements of AGE with the SCOUT device to diabetes complications.
Status | Completed |
Enrollment | 250 |
Est. completion date | August 2011 |
Est. primary completion date | August 2011 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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 |
Observational Model: Cohort, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
United States | Medstar Health Research Institute | Hyattsville | Maryland |
Lead Sponsor | Collaborator |
---|---|
VeraLight, Inc. | Medstar Research Institute |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | SCOUT Comparison | 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). | 1 day | No |
Secondary | Hypertension | 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. | 1 Day | No |
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