Data Mining: Precision Analytical Retrospective Data Correlation
NCT ID: NCT04305093
Last Updated: 2023-03-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
144561 participants
OBSERVATIONAL
2019-12-15
2023-03-28
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Metabolic Effects of Androgenicity in Aging Men and Women
NCT00680797
Prevalence of Secondary Hypogonadism in Male Patients on Chronic Opioid Therapy for Cancer-Related Pain Syndromes
NCT00529230
Exploring the Relationship Between Androgen Metabolism, Metabolic Disease and Skeletal Muscle Energy Balance in Men
NCT05773183
Effects of Osteoarthritis Pain, Morphine, and Placebo on Neuroendocrine Function in Men
NCT00088296
Evaluation of Cortisol Resistance in Young Sedentary and Endurance-Trained Men
NCT01294319
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
This study will involve analysis of existing data from routine clinical care. All data will be deidentified and each set of results will be given a study ID number. The key will be held by Danielle Martinot and will contain only the original Precision Analytical sample accession number and the new study ID (identification). No identifying PHI (Protected Health Information) will be accessible to the PI.
These data will be used to evaluate the following hypotheses: 1) Urinary hormone measures accurately reflect expected changes in hormones with regard to circadian rhythm, menstrual status, and use of hormonal medications; 2) Urinary metabolites of cortisol will show a stronger association with body mass index and symptoms related to cortisol production as compared to salivary measures; 3) Urine values of reproductive hormones and organic acids will correlate to the dosing of estrogen and androgens more strongly than to progesterone creams; 4) 8-OHdG, a measure of oxidative stress, and melatonin will be correlated with age and BMI; and 5) Urinary hormone measures will capture age-related changes in hormone regulation.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
OTHER
RETROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Precision Analytical patients
Individuals who had laboratory work completed at Precision Analytical and completed the associated questionnaire on symptoms and comorbidities.
No interventions assigned to this group
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
Exclusion Criteria
18 Years
85 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Precision Analytical, Inc.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Mark Newman, MS
Role: PRINCIPAL_INVESTIGATOR
Precision Analytical, Inc.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Precision Analytical, Inc
McMinnville, Oregon, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Abraham SB, Rubino D, Sinaii N, Ramsey S, Nieman LK. Cortisol, obesity, and the metabolic syndrome: a cross-sectional study of obese subjects and review of the literature. Obesity (Silver Spring). 2013 Jan;21(1):E105-17. doi: 10.1002/oby.20083.
DUNKELMAN SS, FAIRHURST B, PLAGER J, WATERHOUSE C. CORTISOL METABOLISM IN OBESITY. J Clin Endocrinol Metab. 1964 Sep;24:832-41. doi: 10.1210/jcem-24-9-832. No abstract available.
Newman M, Pratt SM, Curran DA, Stanczyk FZ. Evaluating urinary estrogen and progesterone metabolites using dried filter paper samples and gas chromatography with tandem mass spectrometry (GC-MS/MS). BMC Chem. 2019 Feb 4;13(1):20. doi: 10.1186/s13065-019-0539-1. eCollection 2019 Dec.
Pasquali R, Cantobelli S, Casimirri F, Capelli M, Bortoluzzi L, Flamia R, Labate AM, Barbara L. The hypothalamic-pituitary-adrenal axis in obese women with different patterns of body fat distribution. J Clin Endocrinol Metab. 1993 Aug;77(2):341-6. doi: 10.1210/jcem.77.2.8393881.
Rask E, Olsson T, Soderberg S, Andrew R, Livingstone DE, Johnson O, Walker BR. Tissue-specific dysregulation of cortisol metabolism in human obesity. J Clin Endocrinol Metab. 2001 Mar;86(3):1418-21. doi: 10.1210/jcem.86.3.7453.
Stimson RH, Andersson J, Andrew R, Redhead DN, Karpe F, Hayes PC, Olsson T, Walker BR. Cortisol release from adipose tissue by 11beta-hydroxysteroid dehydrogenase type 1 in humans. Diabetes. 2009 Jan;58(1):46-53. doi: 10.2337/db08-0969. Epub 2008 Oct 13.
SZENAS P, PATTEE CJ. Studies on adrenocortical function in obesity. J Clin Endocrinol Metab. 1959 Mar;19(3):344-50. doi: 10.1210/jcem-19-3-344. No abstract available.
Tomlinson JW, Finney J, Hughes BA, Hughes SV, Stewart PM. Reduced glucocorticoid production rate, decreased 5alpha-reductase activity, and adipose tissue insulin sensitization after weight loss. Diabetes. 2008 Jun;57(6):1536-43. doi: 10.2337/db08-0094. Epub 2008 Mar 13.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
MN11819
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.