RECRUITING

Saliva Insulin as Biomarker of Risk Factors for Metabolic Dysregulation and Caries

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

Saliva insulin shows promise as a non-invasive biomarker of high carbohydrate intake and/or insulin resistance, key risk factors for metabolic dysregulation and caries. Saliva insulin monitoring could potentially inform the planning and evaluation of interventions to prevent child obesity, diabetes and caries, without relying on self-reported measures from children, parents, child care providers or teachers. School-based public health screening programs, which have staff and data collection infrastructure in place to regularly and systematically collect saliva during oral health screening, have opportunity to monitor saliva insulin. This randomized controlled trial explores if saliva insulin is responsive to the kinds of obesity and caries intervention currently in progress in schools, namely drinking water intervention. Public health programs may justify adding saliva collection to protocol already in place if saliva insulin data are found to be actionable, i.e. sensitive to risk and intervention.

Official Title

Saliva Insulin as Biomarker of Risk Factors for Metabolic Dysregulation and Caries Which Can be Limited by Drinking Water Intervention in Elementary School Age Children

Quick Facts

Study Start:2022-10-12
Study Completion:2023-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05211843

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:5 Years to 10 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:CHILD
Inclusion CriteriaExclusion Criteria
  1. Age 18 years or older
  2. Willing and able to provide informed consent
  3. Able to understand and follow study procedures
  4. Stable medical condition
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Study Contact

Jodi Stookey, PhD
CONTACT
415-312-0237
jodi.stookey@sfdph.org
Mimansa Cholera, DDS
CONTACT
1-650-445-1710
mimansa.cholera@ucsf.edu

Principal Investigator

Jodi Stookey, PhD
PRINCIPAL_INVESTIGATOR
San Francisco Department of Public Health
Thomas Tanbonliong, DDS
PRINCIPAL_INVESTIGATOR
University of California, San Francisco
Mimansa Cholera, DDS
PRINCIPAL_INVESTIGATOR
University of California, San Francisco

Study Locations (Sites)

UCSF Pediatric Dentistry
San Francisco, California, 94143
United States

Collaborators and Investigators

Sponsor: Jodi Stookey

  • Jodi Stookey, PhD, PRINCIPAL_INVESTIGATOR, San Francisco Department of Public Health
  • Thomas Tanbonliong, DDS, PRINCIPAL_INVESTIGATOR, University of California, San Francisco
  • Mimansa Cholera, DDS, PRINCIPAL_INVESTIGATOR, University of California, San Francisco

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 Date2022-10-12
Study Completion Date2023-12

Study Record Updates

Study Start Date2022-10-12
Study Completion Date2023-12

Terms related to this study

Additional Relevant MeSH Terms

  • Caries
  • Metabolomic Profile