Using SCOUT Noninvasive AGE Measurements to Forecast Diabetes Complications (MARC)

This study has been completed.
Sponsor:
Collaborator:
Medstar Research Institute
Information provided by:
VeraLight, Inc.
ClinicalTrials.gov Identifier:
NCT01415115
First received: August 9, 2011
Last updated: August 10, 2011
Last verified: August 2011
  Purpose

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


Condition
Type 1 Diabetes
Type 2 Diabetes

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Cross-Sectional Study to Test the Feasibility of Using SCOUT Noninvasive AGE Measurements to Forecast Diabetes Complications

Resource links provided by NLM:


Further study details as provided by VeraLight, Inc.:

Primary Outcome Measures:
  • SCOUT Comparison [ Time Frame: 1 day ] [ Designated as safety issue: No ]
    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).


Secondary Outcome Measures:
  • Hypertension [ Time Frame: 1 Day ] [ Designated as safety issue: No ]
    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.


Biospecimen Retention:   None Retained

Blood samples will be drawn for laboratory-based quantification of HbA1c and lipids. Urine samples will be collected to determine urine creatinine and microalbumin


Enrollment: 250
Study Start Date: March 2007
Study Completion Date: August 2011
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.
Type 2 Diabetes
Must have been diagnosed with Type 2 diabetes. This group will be compared to the Type 1 cohort.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Potential subjects for the study will have type 1 or type 2 diabetes.

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01415115

Locations
United States, Maryland
Medstar Health Research Institute
Hyattsville, Maryland, United States, 20783
Sponsors and Collaborators
VeraLight, Inc.
Medstar Research Institute
Investigators
Principal Investigator: Robert Ratner, MD Medstar
  More Information

No publications provided

Responsible Party: Robert Ratner MD, Medstar Health Research Institute
ClinicalTrials.gov Identifier: NCT01415115     History of Changes
Other Study ID Numbers: VL-2702
Study First Received: August 9, 2011
Last Updated: August 10, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by VeraLight, Inc.:
diabetes
hypertension

Additional relevant MeSH terms:
Diabetes Complications
Diabetes Mellitus
Diabetes Mellitus, Type 1
Diabetes Mellitus, Type 2
Autoimmune Diseases
Endocrine System Diseases
Glucose Metabolism Disorders
Immune System Diseases
Metabolic Diseases

ClinicalTrials.gov processed this record on October 23, 2014