Evaluation of Low Source of Signal in SCOUT DS

Metabolic Syndrome Clinical Trial

— LSS  

Official title:

Evaluation of Low Source of Signal in SCOUT DS

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01339637
• Other study ID #: VL-2718
• Status: Completed
• Phase: N/A
• First received: April 18, 2011
• Last updated: December 3, 2012
• Start date: April 2011
• Est. completion date: October 2011

Study information

• Verified date: December 2012
• Source: VeraLight, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 196
• Est. completion date: October 2011
• Est. primary completion date: September 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Dark Skin Tone (Von Luschan chromatic skin color > 35)

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:

• 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)

• Prior bariatric surgery

Study Design

Observational Model: Cohort, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Diabetes, Gestational
• Gestational Diabetes
• Glucose Intolerance
• Impaired Glucose Tolerance
• Metabolic Syndrome
• Metabolic Syndrome X

Locations

Country	Name	City	State
United States	Radiant Research	Atlanta	Georgia
United States	Radiant Research	Birmingham	Alabama
United States	Radiant Research	Chicago	Illinois
United States	Radiant Research	Kansas City	Missouri
United States	Accelovance	Rockville	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
VeraLight, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Compare SCOUT DS and FPG to HbA1c	Secondary endpoint is to evaluate the receiver operator characteristic area under the curve, sensitivity, specificity, and positive (PPV) and negative (NPV) predictive values of SCOUT DS, FPG, and A1C test for detection of abnormal glucose tolerance.	6 months	No