Cardiovascular Diseases, Metabolic Syndrome, Obesity, Prediabetes, Mental Health Disorders, Endocrine Dysfunction, Type 2 Diabetes Mellitus (T2DM), Chronic Kidney Disease (CKD)
Conditions
Brief summary
DOVE-MET-COME-100 is a single site prescreening survey study designed to identify adults who may be eligible for future industry-sponsored clinical trials. A physician will oversee the informed consent process, after which participants will be surveyed on demographics, medical history, current health conditions and symptoms. The study team may also collect basic health information, including vital signs, urine drug tests, blood samples and pregnancy tests (if applicable). A physician will review each participant's medical history in a one-on-one interview to assess potential fit for upcoming trials. If needed, the doctor may contact the participant's current doctors or pharmacies to gather more information for eligibility review.
Detailed description
Eligible participants will undergo screening procedures including laboratory assessments and health questionnaires to determine their suitability for further evaluation in metabolic and/or psychiatric sub-studies. The study does not include any investigational intervention.
Interventions
OTHERBlood Work
Collection of blood samples for metabolic and other necessary biomarker analysis, including Hemoglobin A1c (HbA1c), Lipid Panel, Liver and Kidney function tests and other protocol-defined assays.
Sponsors
Clindove Research LLC
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Any participant of age 18 years and over * Who are willing to provide informed consent and participate in the pre-screening study and comply with study procedures.
Exclusion criteria
* Pregnant or breastfeeding individuals * Individuals having severe cognitive impairment or inability to provide informed consent * Individuals having acute psychiatric emergencies requiring immediate intervention/hospitalization * Individuals who are currently participating in another research study that conflicts with pre-screening data collection * Individuals having known history of drug/alcohol misuse * Individuals having medical conditions that, in the investigator's opinion, could compromise the integrity of the screening process or pose significant risks to the participant's health.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants who express interest in industry-sponsored clinical research | 5 years | The number of participants who express interest in industry-sponsored clinical research in each of the following therapeutic areas: cardiovascular, endocrine, metabolic and mental health disorder. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Development of a systematically curated and structured electronic database of pre-screened individuals, annotated with metabolic, cardiovascular, endocrine, and psychiatric risk factors | 5 years | Development of a systematically curated and structured electronic database of pre-screened individuals, annotated with metabolic, cardiovascular, endocrine, and psychiatric risk factors, for the purpose of streamlined matching and recruitment into future interventional trials. This will include demographic, clinical, laboratory, and mental health data with longitudinal tracking capacity for re-contact and follow-up. |
Countries
United States
Contacts
Primary ContactNelly Cohen, MD
Outcome results
None listed