Metabolic SyndromeLSSNCT01339637
Evaluation of Low Source of Signal in SCOUT DS
An observational study of Metabolic Syndrome and Impaired Glucose Tolerance, run by VeraLight, Inc. at 5 sites in United States.
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metabolic Syndrome, Impaired Glucose Tolerance, Gestational Diabetes
- How many people
- 196 participants
- Where
- 5 sitesUnited States
- Study dates
- Apr 2011to Oct 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Community sample
Who may be able to join
- 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
Show all 14Show fewer
- 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
Who cannot join
- 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
Show all 16Show fewer
- 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
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Radiant Research
Atlanta, Georgia
Radiant Research
Birmingham, Alabama
Radiant Research
Chicago, Illinois
Radiant Research
Kansas City, Missouri
Accelovance
Rockville, Maryland
About this study
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).
- Keywords
- Impaired Glucose Tolerance, Diabetes Risk Factors, Dark Skin
- Medical subject headings
- Metabolic Syndrome, Glucose Intolerance, Diabetes, Gestational
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Diabetes risk factors | Very dark skin subjects with with diabetes risk factors |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 6 months
Secondary outcomes (1)
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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2011 (estimated)
- Study startApr 2011
- Primary completionSep 2011
- Study completionOct 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metabolic SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 196 participants (actual)
Sponsor and investigators
- Lead sponsor
- VeraLight, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- John Maynard, MS, Study director, VeraLight, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01339637
- Sponsor's protocol ID
- VL-2718
- Acronym
- LSS
- Status last verified
- Dec 2012
- First submitted
- 18 Apr 2011
- Last updated
- 5 Dec 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Low Source of Signal in SCOUT DS
- ClinicalTrials.gov ID
- NCT01339637
- Acronym / sponsor ID
- LSS / VL-2718
- Keywords
- Impaired Glucose Tolerance, Diabetes Risk Factors, Dark Skin
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 196 participants (actual)
- Lead sponsor
- VeraLight, Inc.Industry (pharma, biotech, devices)
- Study start
- Apr 2011
- Primary completion
- Sep 2011 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 20 Apr 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Diabetes risk factors | – | –Very dark skin subjects with with diabetes risk factors |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Community sample
Key inclusion criteria (14 listed)
- 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:
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Validation of the SCOUT DS algorithm comparing it to Oral Glucose Tolerance Test in dark skinned individuals
Time frame: 6 months
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).
1 secondary outcome
Compare SCOUT DS and FPG to HbA1c
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2012.
Related trials for Metabolic Syndrome
RecruitingObservational study
Defining the Natural History of Squamous Cell Carcinoma in Fanconi Anemia
Fanconi Anemia, Inherited Bone Marrow Failure Syndrome
Not yet recruitingPhase 2
Osilodrostat for Glycemic Control in Mild Autonomous Cortisol Secretion (MACS) With Difficult-To-Control Type 2 Diabetes - A Randomized, Double-Blind, Placebo-Controlled Phase 2 Study
Mild Autonomous Cortisol Secretion (MACS), Diabetes Mellitus (Type 2)
Active, not recruiting
Effects of Whole-body Electrical Muscle Stimulation Exercise on Adults With Neuromuscular Disease
Neuromuscular Diseases (NMD), Amyotrophic Lateral Sclerosis
Not yet recruitingObservational study
Clinical Genetics Branch Eligibility Screening Survey
Melanoma, Li-Fraumeni Syndrome
Not yet recruitingPhase 2
Effects of Meal Macronutrients on Postprandial Lipids
Nephrotic Syndrome, Lipodystrophy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John Maynard, MS study director
VeraLight, Inc.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Metabolic Syndrome and Impaired Glucose Tolerance, run by VeraLight, Inc. at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Dec 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Validation of the SCOUT DS algorithm comparing it to Oral Glucose Tolerance Test in dark skinned individuals (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2012.