Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
196 participants
OBSERVATIONAL
2011-04-30
2011-10-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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COHORT
CROSS_SECTIONAL
Study Groups
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Diabetes risk factors
Very dark skin subjects with with diabetes risk factors
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
2. Age greater than or equal to 45 years;
OR
3. Age 18 to 44 years and a BMI \> 25 kg/m² with one or more of the following diabetes risk factors:
* Habitually physically inactive (less than 30 minutes of moderate physical activity most, if not all, days of the week)
* Has a first-degree relative with type 2 diabetes
* African American, Latino, Native American, Asian American, Pacific Islander
* Has delivered a baby weighing \> 9 lb or previously diagnosed with gestational diabetes
* Hypertension (≥140/≥ 90 mmHg) or being treated for hypertension
* HDL cholesterol level \< 35 mg/dL and/or a fasting triglyceride level ≥ 250 mg/dL or being treated for dyslipidemia with medication
* Has been previously diagnosed with Polycystic Ovary Syndrome (PCOS)
* Had impaired glucose tolerance or impaired fasting glucose on previous testing within the last 3 years
* Conditions associated with insulin resistance such as severe obesity or acanthosis nigricans
* History of vascular disease including heart attack, stroke, angina, coronary heart disease, atherosclerosis, congestive heart failure or peripheral arterial disease
Exclusion Criteria
* Under 18 years of age
* Receiving investigational treatments in the past 14 days
* Psychosocial issues that interfere with an ability to follow study procedures
* Conditions that cause secondary diabetes including Cushing's syndrome, acromegaly, hemochromatosis, pancreatitis, or cystic fibrosis
* Diagnosed with any type of diabetes, including type 1 or 2
* Taking glucose lowering medications
* Known to be pregnant
* Receiving dialysis or having known renal compromise
* Scars, tattoos, rashes or other disruption/discoloration on the left volar forearm.
* Recent (within past month) or current oral steroid therapy or topical steroids applied to the left forearm; inhaled steroid therapy is not excluded
* Current chemotherapy, or chemotherapy within the past 12 months
* Receiving medications that fluoresce\*
* Known to have, or at risk for, photosensitivity reactions ( e.g., sensitive to ultraviolet light, or taking medication known to cause photosensitivity)
* Known to have, or at risk for, sensitivity to skin lotions or shaving (creams, lotions, soap, shaving cream)
* Prior bariatric surgery
18 Years
ALL
No
Sponsors
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VeraLight, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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John Maynard, MS
Role: STUDY_DIRECTOR
VeraLight, Inc.
Locations
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Radiant Research
Birmingham, Alabama, United States
Radiant Research
Atlanta, Georgia, United States
Radiant Research
Chicago, Illinois, United States
Accelovance
Rockville, Maryland, United States
Radiant Research
Kansas City, Missouri, United States
Countries
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Other Identifiers
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VL-2718
Identifier Type: -
Identifier Source: org_study_id