Evaluation of Low Source of Signal in SCOUT DS (LSS)
Studieoversigt
Status
Status
Betingelser
Betingelser
Undersøgelsestype
Undersøgelsestype
Tilmelding (Faktiske)
Tilmelding
Kontakter og lokationer
Studiesteder
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-
Alabama
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Birmingham, Alabama, Forenede Stater
- Radiant Research
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Georgia
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Atlanta, Georgia, Forenede Stater
- Radiant Research
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Illinois
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Chicago, Illinois, Forenede Stater
- Radiant Research
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Maryland
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Rockville, Maryland, Forenede Stater
- Accelovance
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Missouri
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Kansas City, Missouri, Forenede Stater
- Radiant Research
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-
Deltagelseskriterier
Berettigelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
Inclusion Criteria:
- Dark Skin Tone (Von Luschan chromatic skin color > 35)
Age greater than or equal to 45 years;
OR
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Antal grupper/kohorter
Kohorter og interventioner
Gruppe / kohorteGruppe / kohorte |
|---|
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Diabetes risk factors
Very dark skin subjects with with diabetes risk factors
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Hvad måler undersøgelsen?
Primære resultatmål
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Validation of the SCOUT DS algorithm comparing it to Oral Glucose Tolerance Test in dark skinned individuals
Tidsramme: 6 months
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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).
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6 months
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Sekundære resultatmål
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Compare SCOUT DS and FPG to HbA1c
Tidsramme: 6 months
|
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.
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6 months
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Samarbejdspartnere og efterforskere
Sponsor
Sponsor
Efterforskere
Efterforskere
- Studieleder: John Maynard, MS, VeraLight, Inc.
Datoer for undersøgelser
Studer store datoer
Studiestart
Studiestart
Primær færdiggørelse (Faktiske)
Primær færdiggørelse
Studieafslutning (Faktiske)
Studieafslutning
Datoer for studieregistrering
Først indsendt
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Først opslået
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering sendt
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
Andre undersøgelses-id-numre
- VL-2718
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