Data Mining: Precision Analytical Retrospective Data Correlation

Overview

Data from previously analyzed clinical samples tested by Precision Analytical, Inc. will be mined to identify and select samples from patients reporting hormone supplement use. Patient demographics (BMI, for example), different therapies and expected changes in hormone levels will be analyzed and hormone metabolite patterns will be compared. Samples will be deidentified prior to analysis.

Full Title of Study: “Precision Analytical Retrospective Data Correlation”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Retrospective
  • Study Primary Completion Date: January 30, 2020

Detailed Description

The investigators have a list of 10 estrogen metabolites, 8 androgen metabolites, two progesterone metabolites, 4 cortisol metabolites, free cortisol, six organic acids, 8-hydroxy-2'-deoxyguanosine (8-OHdG), and melatonin that are measured on patient urine samples and cortisol and cortisone on patient saliva samples. The investigators would like to both reinforce the validation of the accuracy of these urinary markers and examine how these markers associate with patient demographics, symptoms, hormone therapy doses and routes of administration.

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.

Arms, Groups and Cohorts

  • Precision Analytical patients
    • Individuals who had laboratory work completed at Precision Analytical and completed the associated questionnaire on symptoms and comorbidities.

Clinical Trial Outcome Measures

Primary Measures

  • BMI – weight and height will be combined to report BMI in kg/m2
    • Time Frame: 6 months
    • Relationship of BMI to cortisol production and clearance
  • Urinary hormonal profile including concentrations of estrone, estradiol, estriol, alpha-pregnanediol, and beta-pregnanediol
    • Time Frame: 6 months
    • Determination of urine estrogen and progesterone metabolites in postmenopausal women receiving hormonal treatment

Participating in This Clinical Trial

Inclusion Criteria

  • Had testing done at Precision Analytical between 2016 and 2019

Exclusion Criteria

  • Varies by data analysis

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 85 Years

Investigator Details

  • Lead Sponsor
    • Precision Analytical, Inc.
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Mark Newman, MS, Principal Investigator, Precision Analytical, Inc.

References

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.

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.

Rask E, Olsson T, Söderberg 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.

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.

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.

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