Obesity; EndocrineNCT04305093
Data Mining: Precision Analytical Retrospective Data Correlation
An observational study of Obesity; Endocrine and Hormone Disturbance, run by Precision Analytical, Inc. at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Obesity; Endocrine, Hormone Disturbance
- How many people
- 144,561 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Dec 2019to 28 Mar 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- Adult, Older adult
Study population: Individuals between the ages of 18 and 85 years with data in the Precision Analytical database
Who may be able to join
- Had testing done at Precision Analytical between 2016 and 2019
Who cannot join
- Varies by data analysis
Trial locations and contacts
1 site in 1 country.
United States1 site
Precision Analytical, Inc
McMinnville, Oregon, 97128
About this study
Official title: Precision Analytical Retrospective Data Correlation
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.
Read the 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.
- Conditions
- Obesity; Endocrine, Hormone Disturbance
- Keywords
- Cortisol, Cortisol metabolites, Obesity, testosterone, estradiol, Hormone therapy, Sleep disturbance, Aging
- Medical subject headings
- Obesity, Endocrine System Diseases, Parasomnias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Precision Analytical patients | Individuals who had laboratory work completed at Precision Analytical and completed the associated questionnaire on symptoms and comorbidities. |
What is being measured
The primary outcome is the main question the study is designed to answer.
BMI - weight and height will be combined to report BMI in kg/m2
Relationship of BMI to cortisol production and clearance
Measured: 6 months
Urinary hormonal profile including concentrations of estrone, estradiol, estriol, alpha-pregnanediol, and beta-pregnanediol
Determination of urine estrogen and progesterone metabolites in postmenopausal women receiving hormonal treatment
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2020
- Study start15 Dec 2019
- Primary completion28 Mar 2023
- Study completion28 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Obesity; EndocrineStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 144,561 participants (actual)
Sponsor and investigators
- Lead sponsor
- Precision Analytical, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mark Newman, MS, Principal investigator, Precision Analytical, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04305093
- Sponsor's protocol ID
- MN11819
- Status last verified
- Mar 2023
- First submitted
- 9 Mar 2020
- Last updated
- 30 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 23505190DUNKELMAN 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.
PubMed 14216471Newman 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.
PubMed 31384769Pasquali 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.
PubMed 8393881Rask 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.
PubMed 11238541Stimson 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.
PubMed 18852329SZENAS 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.
PubMed 13631051Tomlinson 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.
PubMed 18340018
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Precision Analytical Retrospective Data Correlation
- ClinicalTrials.gov ID
- NCT04305093
- Acronym / sponsor ID
- MN11819
- Conditions
- Obesity; Endocrine, Hormone Disturbance
- Keywords
- Cortisol, Cortisol metabolites, Obesity, testosterone, estradiol, Hormone therapy, Sleep disturbance, Aging
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 144,561 participants (actual)
- Lead sponsor
- Precision Analytical, Inc.Industry (pharma, biotech, devices)
- Study start
- 15 Dec 2019 (actual)
- Primary completion
- 28 Mar 2023 (actual)
- Study completion
- 28 Mar 2023 (actual)
- First posted
- 12 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Precision Analytical patients | – | –Individuals who had laboratory work completed at Precision Analytical and completed the associated questionnaire on symptoms and comorbidities. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Individuals between the ages of 18 and 85 years with data in the Precision Analytical database
Key inclusion criteria (1 listed)
- Had testing done at Precision Analytical between 2016 and 2019
Key exclusion criteria (1 listed)
- Varies by data analysis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2023.
- Background: PubMed 23505190Abraham 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.
- Background: PubMed 14216471DUNKELMAN 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.
- Background: PubMed 31384769Newman 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.
- Background: PubMed 8393881Pasquali 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.
- Background: PubMed 11238541Rask 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.
- Background: PubMed 18852329Stimson 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.
- Background: PubMed 13631051SZENAS 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.
- Background: PubMed 18340018Tomlinson 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mark Newman, MS principal investigator
Precision Analytical, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity; Endocrine and Hormone Disturbance, run by Precision Analytical, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
BMI - weight and height will be combined to report BMI in kg/m2 (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04305093, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2023; AzTrials last refreshed its copy on 27 Oct 2026.