Non-interventional Pre-screening Protocol Aims to Evaluate Participants for Potential Trial Eligibility in Future Clinical Trials/Studies Focusing on Metabolic and Psychiatric Health.

NCT07106879 | Recruiting

• 1 other identifier: METCOME062025
• Study Type: observational
• Target: 7,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiovascular Diseases; Metabolic Syndrome; Obesity; Prediabetes; Mental Health Disorders; Endocrine Dysfunction; Type 2 Diabetes Mellitus (T2DM); Chronic Kidney Disease (CKD)

Outcome Measures

Primary Outcomes (1)

• Number of participants who express interest in industry-sponsored clinical research

  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.

  5 years

Secondary Outcomes (1)

• Development of a systematically curated and structured electronic database of pre-screened individuals, annotated with metabolic, cardiovascular, endocrine, and psychiatric risk factors

  5 years

Study Arms (1)

All Participants

Participants undergoing metabolic and/or psychiatric assessments through blood work and structured clinical evaluations, as outlined in the study protocol.

Other: Blood Work

Interventions

Blood Work OTHER

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.

All Participants

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

This study will enroll participants of any sex, aged 18 and over from a general outpatient population, including both self-referred individuals and those referred by healthcare providers. Participants will undergo metabolic and/or psychiatric evaluations through structured interviews and blood-based biomarker assessments. Individuals interested in participating in an industry-sponsored clinical trial for investigational products targeting cardiovascular, obesity, or endocrine conditions will be screened for clinical suitability. Eligible participants may present with symptoms related to metabolic or psychiatric conditions, or both.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Clindove Research LLC: lead

Study Sites (1)

Clindove Research LLC

Brooklyn, New York, 11221, United States

RECRUITING

Related Links

• Clindove Research LLC Website

MeSH Terms

Conditions

Cardiovascular Diseases; Metabolic Syndrome; Obesity; Prediabetic State; Diabetes Mellitus, Type 2; Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Overweight; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Diabetes Mellitus; Endocrine System Diseases; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes

Study Officials

• Nelly Cohen, MD

  Clindove Research LLC

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nelly Cohen, MD

CONTACT

516-518-3239; study@clindoveresearch.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 30, 2025
• First Posted: August 6, 2025
• Study Start: July 30, 2025
• Primary Completion (Estimated): July 1, 2030
• Study Completion (Estimated): December 1, 2030
• Last Updated: August 12, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)