RECRUITING

Routine Validation and Reproducibility Testing of Laboratory Measures and Research Techniques Used for Metabolism Research (VAL)

Conditions

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

The purpose of this research study is to validate (check the accuracy of) laboratory assays, intravenous catheter insertion, and equipment or devices and their reproducibility, which is necessary to perform high quality research on chronic diseases (obesity, pre-diabetes and type-2 diabetes, dyslipidemia, non-alcoholic fatty liver disease, cardiovascular disease, etc.), nutrition, and metabolism (the process by which a substance is handled in your body) at the University of Missouri. As technology changes and we start to use new testing methods, it is necessary to compare results from old tests, equipment and devices and new tests, equipment, or devices and the reproducibility of these measurements to make sure we are getting accurate results. Reproducibility means performing the same test more than once to see if the same results can be achieved each time.

Official Title

Routine Validation and Reproducibility Testing of Laboratory Assays and Research Techniques Used for Metabolism Research

Quick Facts

Study Start:2024-05-08
Study Completion:2028-03
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06286761

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 75 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * ≥18 and ≤75 years of age
  2. * body mass index ≥18.5 and ≤45 kg/m2
  3. * Weight stable (i.e., ≤3% change)
  4. * ≤150 min of structured exercise/week for at least 2 months before entering the study
  5. * Blood glucose: \< 126 mg/dl fasted, \< 200 mg/dl with 2 hour oral glucose tolerance testing
  6. * Hemoglobin A1C (HbA1C) ≤6.5%
  7. * Dyslipidemia triglycerides ≥125 mg/dL
  8. * No chronic kidney disease
  9. * Not vegan or vegetarian or on high protein diet (e.g. Atkins) or supplements that are not allowed
  10. * No intolerance or allergies to study diet ingredients
  11. * No excessive alcohol or tobacco consumption
  1. * \<18 and \>75 years of age
  2. * body mass index \<18.5 or \>45 kg/m2
  3. * history of or current significant organ system dysfunction (e.g., heart disease, stroke, diabetes, cancer in remission for \<5 years, dementia, chronic kidney disease)
  4. * allergies or intolerances to meal ingredients, vegans or vegetarians
  5. * use of medications that could confound the study outcomes (e.g., anti-inflammatories, immune modulators, etc)
  6. * take dietary supplements (e.g., certain pre- and pro-biotics, fiber, fish oil supplements)
  7. * engaged in regular structured exercise \>150 min per week
  8. * alcohol use disorder as defined by the National Institute of Alcohol Abuse and Alcoholism or use of controlled substances
  9. * pregnant women
  10. * persons who use tobacco
  11. * prisoners
  12. * the inability to grant voluntary informed consent.

Contacts and Locations

Study Contact

Heather McHatton, MPH, RN
CONTACT
(573) 882-7619
heathermchatton@health.missouri.edu
Vasavi Shabrish, PhD
CONTACT
v.shabrish@missouri.edu

Principal Investigator

Bettina Mittendorfer, PhD
PRINCIPAL_INVESTIGATOR
University of Missouri-Columbia

Study Locations (Sites)

University of Missouri School of Medicine
Columbia, Missouri, 65212
United States

Collaborators and Investigators

Sponsor: Bettina Mittendorfer

  • Bettina Mittendorfer, PhD, PRINCIPAL_INVESTIGATOR, University of Missouri-Columbia

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 Date2024-05-08
Study Completion Date2028-03

Study Record Updates

Study Start Date2024-05-08
Study Completion Date2028-03

Terms related to this study

Additional Relevant MeSH Terms

  • Obesity