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

Obesity Clinical Trial

— VAL  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06286761
• Other study ID #: 2100332
• Status: Recruiting
• Start date: May 8, 2024
• Est. completion date: March 2028

Study information

• Verified date: June 2024
• Source: University of Missouri-Columbia
• Contact: Heather McHatton, MPH, RN
• Phone: (573) 882-7619
• Email: heathermchatton[@]health.missouri.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: March 2028
• Est. primary completion date: March 2028
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• =18 and =75 years of age

• body mass index =18.5 and =45 kg/m2

• Weight stable (i.e., =3% change)

• =150 min of structured exercise/week for at least 2 months before entering the study

• Blood glucose: < 126 mg/dl fasted, < 200 mg/dl with 2 hour oral glucose tolerance testing

• Hemoglobin A1C (HbA1C) =6.5%

• Dyslipidemia triglycerides =125 mg/dL

• No chronic kidney disease

• Not vegan or vegetarian or on high protein diet (e.g. Atkins) or supplements that are not allowed

• No intolerance or allergies to study diet ingredients

• No excessive alcohol or tobacco consumption

Exclusion Criteria:

• <18 and >75 years of age

• body mass index <18.5 or >45 kg/m2

• history of or current significant organ system dysfunction (e.g., heart disease, stroke, diabetes, cancer in remission for <5 years, dementia, chronic kidney disease)

• allergies or intolerances to meal ingredients, vegans or vegetarians

• use of medications that could confound the study outcomes (e.g., anti-inflammatories, immune modulators, etc)

• take dietary supplements (e.g., certain pre- and pro-biotics, fiber, fish oil supplements)

• engaged in regular structured exercise >150 min per week

• alcohol use disorder as defined by the National Institute of Alcohol Abuse and Alcoholism or use of controlled substances

• pregnant women

• persons who use tobacco

• prisoners

• the inability to grant voluntary informed consent.

Related Conditions & MeSH terms

• Obesity

Intervention

Other:
• endothelial cell collection
Participants may opt to have testing performed including blood sampling, intravenous catheter placement with endothelial cell collection, oral glucose tolerance test, consuming a test meal, having imaging performed such as MRI, DEXA, MRS to investigate use of different assays, different sample treatment approaches to determine optimal conditions that produce the most accurate and reproducible results, and/or repeat testing on different days or with different equipment that measures the same variable.

Locations

Country	Name	City	State
United States	University of Missouri School of Medicine	Columbia	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Bettina Mittendorfer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Validation and reproducibility testing for blood assays	insulin, C-peptide, glucagon, substrates (free fatty acids, glucose, ketone bodies) and biomarkers of substrate metabolism (e.g., cytokines and adipokines)	through study completion, an average of 10 weeks
Primary	Validation and reproducibility testing for endothelial cell collection	endothelial cell quantity collected	through study completion, an average of 10 weeks
Primary	Validation and reproducibility testing for mixed meal ingestion	tolerability and palatability of meal type (protein concentration, carbohydrate concentration)	through study completion, an average of 10 weeks
Primary	Validation and reproducibility testing for glucose tolerance testing	glucose levels	through study completion, an average of 10 weeks
Primary	Validation and reproducibility testing for DEXA	body composition analysis	through study completion, an average of 10 weeks
Primary	Validation and reproducibility testing for MRI	body composition analysis	through study completion, an average of 10 weeks
Primary	Validation and reproducibility testing for MRS	body composition analysis	through study completion, an average of 10 weeks