Ignite Creation Date:
2025-12-24 @ 6:38 PM
Ignite Modification Date:
2026-01-02 @ 1:12 PM
Study NCT ID:
NCT07083557
Status:
RECRUITING
Last Update Posted:
2025-11-14
First Post:
2025-05-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Routine Validation and Reproducibility Testing of Laboratory Assays and Research Techniques Used for Endocrine, Cardiometabolic, and Musculoskeletal Disorder Research (VALD)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D006333', 'term': 'Heart Failure'}, {'id': 'D055948', 'term': 'Sarcopenia'}, {'id': 'D010024', 'term': 'Osteoporosis'}, {'id': 'D006961', 'term': 'Hyperparathyroidism'}, {'id': 'D007011', 'term': 'Hypoparathyroidism'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D003550', 'term': 'Cystic Fibrosis'}, {'id': 'D051436', 'term': 'Renal Insufficiency, Chronic'}, {'id': 'D001851', 'term': 'Bone Diseases, Metabolic'}, {'id': 'D002100', 'term': 'Cachexia'}], 'ancestors': [{'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D009133', 'term': 'Muscular Atrophy'}, {'id': 'D020879', 'term': 'Neuromuscular Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D001284', 'term': 'Atrophy'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D010279', 'term': 'Parathyroid Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D010182', 'term': 'Pancreatic Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D007232', 'term': 'Infant, Newborn, Diseases'}, {'id': 'D051437', 'term': 'Renal Insufficiency'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D015431', 'term': 'Weight Loss'}, {'id': 'D001836', 'term': 'Body Weight Changes'}, {'id': 'D013851', 'term': 'Thinness'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2026-01-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2030-07-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-12', 'studyFirstSubmitDate': '2025-05-30', 'studyFirstSubmitQcDate': '2025-07-16', 'lastUpdatePostDateStruct': {'date': '2025-11-14', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-07-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2030-07-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Evaluation of the validity and reproducibility of insulin results in the laboratory environment', 'timeFrame': 'through study completion, up to 6 months', 'description': 'Comparison of insulin results across assays (methods of measuring) to evaluate the validity and reproducibility in the basic science laboratory environment across healthy and disordered populations'}, {'measure': 'Validation and reproducibility testing for endothelial cell collection', 'timeFrame': 'through study completion, up to 6 months', 'description': 'endothelial cell quantity collected'}, {'measure': 'Validation and reproducibility testing for mixed meal ingestion', 'timeFrame': 'through study completion, up to 6 months', 'description': 'palatability of meal type (protein concentration, carbohydrate concentration) as measured by amount of meal consumed'}, {'measure': 'Evaluation of the validity and reproducibility of urinalysis results in the laboratory environment', 'timeFrame': 'through study completion, up to 6 months', 'description': 'Comparison of urinalysis results across assays (methods of measuring) to evaluate the validity and reproducibility in the basic science laboratory environment across healthy and disordered populations'}, {'measure': 'Validation and reproducibility testing for glucose tolerance testing', 'timeFrame': 'through study completion, up to 6 months', 'description': 'glucose levels (mg/dL) at various time points including fasting, random, and postprandial'}, {'measure': 'Validation and reproducibility testing for DEXA', 'timeFrame': 'through study completion, up to 6 months', 'description': 'body composition analysis (percentage fat and muscle)'}, {'measure': 'Validation and reproducibility testing for MRI', 'timeFrame': 'through study completion, up to 6 months', 'description': 'body composition analysis (percentage fat and muscle)'}, {'measure': 'Validation and reproducibility testing for MRS', 'timeFrame': 'through study completion, up to 6 months', 'description': 'body composition analysis (percentage fat and muscle)'}, {'measure': 'Validation and reproducibility of vascular (endothelial) function test', 'timeFrame': 'through study completion, up to 6 months', 'description': 'non-invasive vascular function test (measured using EndoPat machine)'}, {'measure': 'Validation and reproducibility of adipose (fat) tissue biopsy', 'timeFrame': 'through study completion, up to 6 months', 'description': 'microscopic characteristics of tissue collected'}, {'measure': 'Validation and reproducibility testing of muscle tissue biopsies', 'timeFrame': 'through study completion, up to 6 months', 'description': 'microscopic characteristics of tissue collected'}, {'measure': 'Evaluation of the validity and reproducibility of C-peptide results in the laboratory environment', 'timeFrame': 'through study completion, up to 6 months', 'description': 'Comparison of C-peptide results across assays (methods of measuring) to evaluate the validity and reproducibility in the basic science laboratory environment across healthy and disordered populations'}, {'measure': 'Evaluation of the validity and reproducibility of glucagon results in the laboratory environment', 'timeFrame': 'through study completion, up to 6 months', 'description': 'Comparison of glucagon results across assays (methods of measuring) to evaluate the validity and reproducibility in the basic science laboratory environment across healthy and disordered populations'}, {'measure': 'Evaluation of the validity and reproducibility of free fatty acid level results in the laboratory environment', 'timeFrame': 'through study completion, up to 6 months', 'description': 'Comparison of free fatty acid level results across assays (methods of measuring) to evaluate the validity and reproducibility in the basic science laboratory environment across healthy and disordered populations'}, {'measure': 'Evaluation of the validity and reproducibility of glucose results in the laboratory environment', 'timeFrame': 'through study completion, up to 6 months', 'description': 'Comparison of glucose results across assays (methods of measuring) to evaluate the validity and reproducibility in the basic science laboratory environment across healthy and disordered populations'}, {'measure': 'Evaluation of the validity and reproducibility of ketone body results in the laboratory environment', 'timeFrame': 'through study completion, up to 6 months', 'description': 'Comparison of ketone body results across assays (methods of measuring) to evaluate the validity and reproducibility in the basic science laboratory environment across healthy and disordered populations'}, {'measure': 'Evaluation of the validity and reproducibility of cytokine results in the laboratory environment', 'timeFrame': 'through study completion, up to 6 months', 'description': 'Comparison of cytokine results across assays (methods of measuring) to evaluate the validity and reproducibility in the basic science laboratory environment across healthy and disordered populations'}, {'measure': 'Evaluation of the validity and reproducibility of adipokine results in the laboratory environment', 'timeFrame': 'through study completion, up to 6 months', 'description': 'Comparison of adipokine results across assays (methods of measuring) to evaluate the validity and reproducibility in the basic science laboratory environment across healthy and disordered populations'}, {'measure': 'Evaluation of the validity and reproducibility of lipid profile results in the laboratory environment', 'timeFrame': 'through study completion, up to 6 months', 'description': 'Comparison of lipid profile results across assays (methods of measuring) to evaluate the validity and reproducibility in the basic science laboratory environment across healthy and disordered populations'}, {'measure': 'Evaluation of the validity and reproducibility of urine calcium results in the laboratory environment', 'timeFrame': 'through study completion, up to 6 months', 'description': 'Comparison of urine calcium results across assays (methods of measuring) to evaluate the validity and reproducibility in the basic science laboratory environment across healthy and disordered populations'}, {'measure': 'Evaluation of the validity and reproducibility of urine magnesium results in the laboratory environment', 'timeFrame': 'through study completion, up to 6 months', 'description': 'Comparison of urine magnesium results across assays (methods of measuring) to evaluate the validity and reproducibility in the basic science laboratory environment across healthy and disordered populations'}, {'measure': 'Evaluation of the validity and reproducibility of urine phosphorous results in the laboratory environment', 'timeFrame': 'through study completion, up to 6 months', 'description': 'Comparison of urine phosphorous results across assays (methods of measuring) to evaluate the validity and reproducibility in the basic science laboratory environment across healthy and disordered populations'}, {'measure': 'Evaluation of the validity and reproducibility of urine sodium results in the laboratory environment', 'timeFrame': 'through study completion, up to 6 months', 'description': 'Comparison of urine sodium results across assays (methods of measuring) to evaluate the validity and reproducibility in the basic science laboratory environment across healthy and disordered populations'}, {'measure': 'Evaluation of the validity and reproducibility of urine oxalate results in the laboratory environment', 'timeFrame': 'through study completion, up to 6 months', 'description': 'Comparison of urine oxalate results across assays (methods of measuring) to evaluate the validity and reproducibility in the basic science laboratory environment across healthy and disordered populations'}, {'measure': 'Evaluation of the validity and reproducibility of urine citrate results in the laboratory environment', 'timeFrame': 'through study completion, up to 6 months', 'description': 'Comparison of urine citrate results across assays (methods of measuring) to evaluate the validity and reproducibility in the basic science laboratory environment across healthy and disordered populations'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Obesity and Obesity-related Medical Conditions', 'Diabetes', 'Atherosclerotic Disease', 'Heart Failure', 'MASH', 'Sarcopenia', 'Osteoporosis', 'Hyperparathyroidism', 'Hypoparathyroidism', 'Ischemic Heart Disease', 'Cystic Fibrosis (CF)', 'Chronic Kidney Disease(CKD)', 'Osteopenia', 'Cachexia']}, 'descriptionModule': {'briefSummary': '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, nutrition, and metabolism (the process by which a substance is handled in the body) at the University of Missouri. As technology changes and uses 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 the results are accurate. Reproducibility means performing the same test more than once to see if the same results can be achieved each time. This study will look at the validation and reproducibility of tests and laboratory assays in participants who are healthy or affected by relevant endocrine, cardiometabolic, and musculoskeletal disorders.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'convenience population of volunteers in mid-Missouri region', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ≥18 and ≤100 years of age\n* body mass index ≥16.0 and ≤60 kg/m2\n\nExclusion Criteria:\n\n* \\<18 and \\>100 years of age\n* body mass index \\<16.0 or \\>60 kg/m2\n* allergies, intolerances, or dietary restrictions to meal ingredients, vegans or vegetarians\n* use of medications or dietary supplements (e.g., anti-inflammatories, immune modulators, etc) that could interfere with the particular assay/techniques being evaluated\n* engaged in regular structured exercise \\>150 min per week unless needed for validation of the assay/technique being evaluated\n* significant organ system dysfunction or diseases, except those that are sought for validation of the assay/technique being evaluated\n* alcohol use disorder as defined by the National Institute of Alcohol Abuse and Alcoholism or use of controlled substances unless alcohol use disorder is required for validation of the assay/technique being evaluated\n* pregnant women, persons who smoke, prisoners, and inability to grant voluntary informed consent.'}, 'identificationModule': {'nctId': 'NCT07083557', 'acronym': 'VALD', 'briefTitle': 'Routine Validation and Reproducibility Testing of Laboratory Assays and Research Techniques Used for Endocrine, Cardiometabolic, and Musculoskeletal Disorder Research (VALD)', 'organization': {'class': 'OTHER', 'fullName': 'University of Missouri-Columbia'}, 'officialTitle': 'Routine Validation and Reproducibility Testing of Laboratory Assays and Research Techniques Used for Endocrine, Cardiometabolic, and Musculoskeletal Disorder Research (VALD)', 'orgStudyIdInfo': {'id': '2127348'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Endothelial cell collection', 'type': 'OTHER', 'description': 'Participants may opt to have testing performed including blood sampling, urine sampling, intravenous catheter placement with endothelial cell collection, oral glucose tolerance test, consuming a test meal, having imaging performed such as MRI, DEXA, MRS, having adipose (fat) or muscle biopsies, or non-invasive endothelial function testing 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.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '65211', 'city': 'Columbia', 'state': 'Missouri', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Study coordinator', 'role': 'CONTACT', 'email': 'ahmc4@health.missouri.edu', 'phone': '573-884-6852'}], 'facility': 'University of Missouri-Columbia', 'geoPoint': {'lat': 38.95171, 'lon': -92.33407}}], 'centralContacts': [{'name': 'Study coordinator', 'role': 'CONTACT', 'email': 'ahmc4@health.missouri.edu', 'phone': '573-884-6852'}], 'overallOfficials': [{'name': 'Bettina Mittendorfer, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Missouri-Columbia'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bettina Mittendorfer', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Senior Associate Dean for Research; Professor, Medicine & Nutrition; NextGen Director of Clinical and Translational Sciences Unit', 'investigatorFullName': 'Bettina Mittendorfer', 'investigatorAffiliation': 'University of Missouri-Columbia'}}}}