Evaluation of Low Source of Signal in SCOUT DS

NCT01339637 | Completed

• 1 other identifier: VL-2718
• Study Type: observational
• Target: 196
• Locations: 1 country
• Sites: 5

Brief Summary

The overall objective of this study is to increase the number of dark skin tone individuals in the data set and evaluate if this increase in dark skin tone data has an impact on the accuracy of the SCOUT DS Diabetes Risk Score (DRS).

Conditions

Metabolic Syndrome; Impaired Glucose Tolerance; Gestational Diabetes

Keywords

Impaired Glucose Tolerance; Diabetes Risk Factors; Dark Skin

Outcome Measures

Primary Outcomes (1)

• Validation of the SCOUT DS algorithm comparing it to Oral Glucose Tolerance Test in dark skinned individuals

  The primary study endpoint is the relative true positive and relative true negative fractions between the SCOUT DS and FPG test for detecting abnormal glucose tolerance (2 hr OGTT value ≥ 140 mg/dL).

  6 months

Secondary Outcomes (1)

• Compare SCOUT DS and FPG to HbA1c

  6 months

Study Arms (1)

Diabetes risk factors

Very dark skin subjects with with diabetes risk factors

Eligibility Criteria

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

Study Population

Community sample

You may qualify if:

• Dark Skin Tone (Von Luschan chromatic skin color \> 35)
• Age greater than or equal to 45 years;
• 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

You may not qualify if:

• Prior participation under VeraLight protocols: VL-2710, VL-2711 or VL-2712
• 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)

Sponsors & Collaborators

• VeraLight, Inc.: lead

Study Sites (5)

Radiant Research

Birmingham, Alabama, United States

Location

Radiant Research

Atlanta, Georgia, United States

Location

Radiant Research

Chicago, Illinois, United States

Location

Accelovance

Rockville, Maryland, United States

Location

Radiant Research

Kansas City, Missouri, United States

Location

MeSH Terms

Conditions

Metabolic Syndrome; Glucose Intolerance; Diabetes, Gestational

Condition Hierarchy (Ancestors)

Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Hyperglycemia; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Diabetes Mellitus; Endocrine System Diseases

Study Officials

• John Maynard, MS

  VeraLight, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 18, 2011
• First Posted: April 20, 2011
• Study Start: April 1, 2011
• Primary Completion: September 1, 2011
• Study Completion: October 1, 2011
• Last Updated: December 5, 2012

Record last verified: 2012-12

Locations

US (5)