Using SCOUT Noninvasive AGE Measurements to Forecast Diabetes Complications

Type 2 Diabetes Clinical Trial

— MARC  

Official title:

A Cross-Sectional Study to Test the Feasibility of Using SCOUT Noninvasive AGE Measurements to Forecast Diabetes Complications

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01415115
• Other study ID #: VL-2702
• Status: Completed
• Phase: N/A
• First received: August 9, 2011
• Last updated: August 10, 2011
• Start date: March 2007
• Est. completion date: August 2011

Study information

• Verified date: August 2011
• Source: VeraLight, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

The trial is designed as a feasibility study to determine the correlation of noninvasive measurements of AGE with the SCOUT device to diabetes complications.

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.

Recruitment information / eligibility

• 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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Diabetes Complications
• Diabetes Mellitus
• Type 1 Diabetes
• Type 2 Diabetes

Locations

Country	Name	City	State
United States	Medstar Health Research Institute	Hyattsville	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
VeraLight, Inc.	Medstar Research Institute

Country where clinical trial is conducted

United States, 

Outcome

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