Using SCOUT Noninvasive AGE Measurements to Forecast Diabetes Complications

NCT01415115 | Completed

• 1 other identifier: VL-2702
• Study Type: observational
• Target: 250
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Type 1 Diabetes; Type 2 Diabetes

Keywords

diabetes; hypertension

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Hypertension

  1 Day

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• VeraLight, Inc.: lead
• Medstar Health Research Institute: collaborator

Study Sites (1)

Medstar Health Research Institute

Hyattsville, Maryland, 20783, United States

Location

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

MeSH Terms

Conditions

Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2; Diabetes Mellitus; Hypertension

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Robert Ratner, MD

  MedStar Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: August 9, 2011
• First Posted: August 11, 2011
• Study Start: March 1, 2007
• Primary Completion: August 1, 2011
• Study Completion: August 1, 2011
• Last Updated: August 11, 2011

Record last verified: 2011-08

Locations

US (1)