RECRUITING

A Study of a Novel Precision Medicine Approach for Obesity

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This study is being done to assess the efficacy of a saliva- based biomarker to predict response to semaglutide for the treatment of obesity.

Official Title

A Novel Precision Medicine Approach for Obesity: a Randomized, Multi-Center Trial

Quick Facts

Study Start:2025-02-15

Study Completion:2028-11

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06814938

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 65 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
Age 18 years or older Willing and able to provide informed consent Able to understand and follow study procedures Stable medical condition	* Weight changes greater than 3% in the previous 3 months * History of bariatric surgery including lap band and bariatric endoscopy * Significant untreated psychiatric dysfunction based upon screening with the Hospital Anxiety and Depression Inventory (HAD), Questionnaire on Eating and Weight Patterns (binge eating disorders and bulimia) and Columbia Suicide Severity Rating Scale (C-SSRS). If such a dysfunction is identified by an anxiety or depression score \>11 or difficulties with substance or eating disorders, the participant will be excluded and given a referral letter to his/her primary care doctor for further appraisal and follow-up. Any suicidal ideation of type 4 or 5, any suicide attempt during the patient's lifetime, or any suicidal behavior in the last month. * Current use of anti-obesity medications or GLP1R agonists for Type 2 Diabetes * Any contraindication to FDA-approved GLP1R agonists * Positive score on the AUDIT-C questionnaire and any condition that limits their participation in the study * A person who is pregnant or wanting to become pregnant * Principal Investigator Discretion

Inclusion Criteria

Exclusion Criteria

Age 18 years or older
Willing and able to provide informed consent
Able to understand and follow study procedures
Stable medical condition

* Weight changes greater than 3% in the previous 3 months
* History of bariatric surgery including lap band and bariatric endoscopy
* Significant untreated psychiatric dysfunction based upon screening with the Hospital Anxiety and Depression Inventory (HAD), Questionnaire on Eating and Weight Patterns (binge eating disorders and bulimia) and Columbia Suicide Severity Rating Scale (C-SSRS). If such a dysfunction is identified by an anxiety or depression score \>11 or difficulties with substance or eating disorders, the participant will be excluded and given a referral letter to his/her primary care doctor for further appraisal and follow-up. Any suicidal ideation of type 4 or 5, any suicide attempt during the patient's lifetime, or any suicidal behavior in the last month.
* Current use of anti-obesity medications or GLP1R agonists for Type 2 Diabetes
* Any contraindication to FDA-approved GLP1R agonists
* Positive score on the AUDIT-C questionnaire and any condition that limits their participation in the study
* A person who is pregnant or wanting to become pregnant
* Principal Investigator Discretion

Contacts and Locations

Study Contact

Megan Schaefer

CONTACT

507-266-6004

Schaefer.Megan@mayo.edu

Principal Investigator

Andres Acosta, MD, PhD

PRINCIPAL_INVESTIGATOR

Mayo Clinic

Study Locations (Sites)

Mayo Clinic in Florida

Jacksonville, Florida, 32224

United States

Mayo Clinic in Rochester

Rochester, Minnesota, 55905

United States

Collaborators and Investigators

Sponsor: Mayo Clinic

Andres Acosta, MD, PhD, PRINCIPAL_INVESTIGATOR, Mayo Clinic

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-02-15

Study Completion Date2028-11

Study Record Updates

Study Start Date2025-02-15

Study Completion Date2028-11

Terms related to this study

Additional Relevant MeSH Terms

Obesity