AgingBATSPNCT03793127
Brown Adipose Tissue Pilot
An observational study of Aging, run by AdventHealth Translational Research Institute at 1 site in United States.
Trial summary
The primary purpose of this protocol is to develop a reliable method to determine BAT mass in young and older adults by magnetic resonance imaging. Read more about this study
- Who is it for?
- Ages 20 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Aging
- What is being tested?
- Maximal oxygen consumption (V02 max), Brown adipose tissue (BAT) imaging and Muscle function testing
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Jan 2019to Dec 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 20 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Males and females in the age ranges 20-40 and 60-80 years were recruited. Potential participants were medically screened to determine good health, weight stable (no gain/loss of ≥ 10 lbs in 6 months prior to screening), and without any contraindication to exercise. Approximately equal numbers of men and women will be recruited. Neither race nor ethnicity were exclusions.
Who may be able to join
- Capable of providing informed consent and has voluntarily signed and dated an informed consent form, approved by an Institutional Review Board and provided Health Insurance Portability and Accountability Act authorization (HIPAA) or other privacy authorization prior to any participation in study.
- Adult female or male, 20-40 or 60-80 years of age, inclusive at time of screening.
- BMI ≥19.0 and ≤34.9 kg/m2, inclusive at time of screening.
- Stable weight (No gain/loss of ≥ 10 lbs within 6 months prior to screening).
- Non-smokers as defined by not smoked any tobacco or nicotine-containing products vape pens or vaporizers within 3 months prior to screening.
Who cannot join
- History of type 1 or type 2 diabetes per self-report at screening visit 1; or Hgb A1c ≥ 6.5% at screening..
- Actively pursuing weight loss and/or lifestyle changes at time of screening.
- Weight > 450 lbs at screening.
- Uncontrolled hypertension (BP >160 mmHg systolic or >100 mmHg diastolic).
- Mini Mental State Exam (MMSE) <21, only applicable for those 60-80 years of age
- Significant cardiovascular event (e.g. myocardial infarction, stroke) ≤ 6 months prior to screening visit; or stated history of congestive heart failure; or evidence of cardiovascular disease assessed during the ECG at screening.
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- Current infection (requiring prescription antimicrobial or antiviral medication, or hospitalization), or corticosteroid treatment (with the exception of inhaled or topical steroids) in the last 3 months prior to screening visit.
- Prescription strength anti-inflammatory medication in the 6 weeks prior to screening.
- Surgery requiring >2 days of hospitalization in the last 3 weeks prior to screening visit.
- Active malignancy or autoimmune disease.
- History of chronic, contagious, infectious disease, such as active tuberculosis, Hepatitis B or C, or HIV, per self-report.
- History of uncontrolled severe diarrhea, nausea or vomiting within 3 months of screening.
- Uncontrolled severe (including stage III or above) gastrointestinal absorption-related disorders, within 3 months of screening, such as: obstruction of the gastrointestinal tract, inflammatory bowel disease, short bowel syndrome, gastroesophageal reflux disease, gastroparesis, peptic ulcer disease, celiac disease, intestinal dysmotility, diverticulitis, ischemic colitis.
- History of drug or alcohol abuse (> 3 drinks per day) within the last 5 years.
- Pregnant, lactating or is within 6 weeks postpartum prior to the screening visit.
- Metal implants (pace-maker, aneurysm clips) based on Investigator's judgment at screening.
- Unable to participate in MRI assessments due to physical limitations of equipment tolerances (e.g. MRI bore size) based on Investigator's judgment at screening.
- Unable to tolerate MRI imaging or claustrophobia.
- Urine albumin-to-creatinine ratio (UACR) ≥300 mg/g in a single urine specimen (per National Kidney Foundation guideline) at screening.
- Impaired renal function: estimated glomerular filtration rate (eGFR) ≤ 50 ml/min/1.73m2 determined at screening.
- Significantly impaired liver function in the opinion of the study PI (mild asymptomatic fatty liver is acceptable), or hepatic enzyme tests are ≥2.5 times normal limit at time of screening.
- Total cholesterol level is ˃300 mg/dL at screening.
- Participant has inadequately treated hyperthyroidism (thyroid stimulating hormone [TSH] below normal range) or hypothyroidism (TSH>ULN (upper limit normal) to <10U/mL and symptomatic, or TSH >10 U/mL) at time of screening.
Trial locations and contacts
1 site in 1 country.
United States1 site
Translational Research Institute for Metabolism and Diabetes
Orlando, Florida, 32804
About this study
Official title: BAT as a Therapeutic for the Metabolic and Cardiac Dysfunction With Senescence Pilot
The primary purpose of this protocol is to develop a reliable method to determine BAT mass in young and older adults by magnetic resonance imaging.
- Conditions
- Aging
- Being tested
- Maximal oxygen consumption (V02 max), Brown adipose tissue (BAT) imaging, Muscle function testing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Maximal oxygen consumption (V02 max)Other
Aerobic fitness will be determined by measuring V02 max during a stationary bicycle exercise test.
Brown adipose tissue (BAT) imagingOther
Brown adipose tissue will be differentiated from white adipose tissue using fat fraction and T2* relaxation time maps generated from a commercially available modified 6-point Dixon (mDixon) water-fat separation method.
Muscle function testingOther
This test will be done on a machine called a Biodex. We will measure the speed at which subjects move resistance at different percentages of their peak strength.
| Study group | Role | What they receive |
|---|---|---|
| Young group | 20-40 years of age Receives: Other: Maximal oxygen consumption (V02 max); Other: Brown adipose tissue (BAT) imaging; Other: Muscle function testing | |
| Old group | 60-80 years of age Receives: Other: Maximal oxygen consumption (V02 max); Other: Brown adipose tissue (BAT) imaging; Other: Muscle function testing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Collection of imaging of BAT by magnetic resonance imaging from 10 participants in each of young and old study groups.
Brown adipose tissue will be differentiated from white adipose tissue using fat fraction and T2* relaxation time maps generated from a commercially available modified 6-point Dixon (mDixon) water-fat separation method. The participant may be removed from the magnet and repositioned during the exam in order to determine the same day variability of this method.
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2019
- Study start23 Jan 2019
- Primary completion13 May 2019
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (19)Papers the sponsor has linked to this study.
- Other trials for AgingStudies 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
- Prospective
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- AdventHealth Translational Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Paul Coen, PhD, Principal investigator, Study principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03793127
- Sponsor's protocol ID
- TRIMD 1344107
- Acronym
- BATSP
- Status last verified
- Jun 2025
- First submitted
- 14 Dec 2018
- Last updated
- 11 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kodama S, Saito K, Tanaka S, Maki M, Yachi Y, Asumi M, Sugawara A, Totsuka K, Shimano H, Ohashi Y, Yamada N, Sone H. Cardiorespiratory fitness as a quantitative predictor of all-cause mortality and cardiovascular events in healthy men and women: a meta-analysis. JAMA. 2009 May 20;301(19):2024-35. doi: 10.1001/jama.2009.681.
PubMed 19454641Costantino S, Paneni F, Cosentino F. Ageing, metabolism and cardiovascular disease. J Physiol. 2016 Apr 15;594(8):2061-73. doi: 10.1113/JP270538. Epub 2015 Oct 22.
PubMed 26391109Kalyani RR, Egan JM. Diabetes and altered glucose metabolism with aging. Endocrinol Metab Clin North Am. 2013 Jun;42(2):333-47. doi: 10.1016/j.ecl.2013.02.010. Epub 2013 Mar 22.
PubMed 23702405Cypess AM, Lehman S, Williams G, Tal I, Rodman D, Goldfine AB, Kuo FC, Palmer EL, Tseng YH, Doria A, Kolodny GM, Kahn CR. Identification and importance of brown adipose tissue in adult humans. N Engl J Med. 2009 Apr 9;360(15):1509-17. doi: 10.1056/NEJMoa0810780.
PubMed 19357406van Marken Lichtenbelt WD, Vanhommerig JW, Smulders NM, Drossaerts JM, Kemerink GJ, Bouvy ND, Schrauwen P, Teule GJ. Cold-activated brown adipose tissue in healthy men. N Engl J Med. 2009 Apr 9;360(15):1500-8. doi: 10.1056/NEJMoa0808718.
PubMed 19357405Saito M, Okamatsu-Ogura Y, Matsushita M, Watanabe K, Yoneshiro T, Nio-Kobayashi J, Iwanaga T, Miyagawa M, Kameya T, Nakada K, Kawai Y, Tsujisaki M. High incidence of metabolically active brown adipose tissue in healthy adult humans: effects of cold exposure and adiposity. Diabetes. 2009 Jul;58(7):1526-31. doi: 10.2337/db09-0530. Epub 2009 Apr 28.
PubMed 19401428Stanford KI, Middelbeek RJ, Townsend KL, An D, Nygaard EB, Hitchcox KM, Markan KR, Nakano K, Hirshman MF, Tseng YH, Goodyear LJ. Brown adipose tissue regulates glucose homeostasis and insulin sensitivity. J Clin Invest. 2013 Jan;123(1):215-23. doi: 10.1172/JCI62308. Epub 2012 Dec 10.
PubMed 23221344Berbee JF, Boon MR, Khedoe PP, Bartelt A, Schlein C, Worthmann A, Kooijman S, Hoeke G, Mol IM, John C, Jung C, Vazirpanah N, Brouwers LP, Gordts PL, Esko JD, Hiemstra PS, Havekes LM, Scheja L, Heeren J, Rensen PC. Brown fat activation reduces hypercholesterolaemia and protects from atherosclerosis development. Nat Commun. 2015 Mar 10;6:6356. doi: 10.1038/ncomms7356.
PubMed 25754609Gunawardana SC, Piston DW. Reversal of type 1 diabetes in mice by brown adipose tissue transplant. Diabetes. 2012 Mar;61(3):674-82. doi: 10.2337/db11-0510. Epub 2012 Feb 7.
PubMed 22315305Thoonen R, Ernande L, Cheng J, Nagasaka Y, Yao V, Miranda-Bezerra A, Chen C, Chao W, Panagia M, Sosnovik DE, Puppala D, Armoundas AA, Hindle A, Bloch KD, Buys ES, Scherrer-Crosbie M. Functional brown adipose tissue limits cardiomyocyte injury and adverse remodeling in catecholamine-induced cardiomyopathy. J Mol Cell Cardiol. 2015 Jul;84:202-11. doi: 10.1016/j.yjmcc.2015.05.002. Epub 2015 May 9.
PubMed 25968336Stanford KI, Lynes MD, Takahashi H, Baer LA, Arts PJ, May FJ, Lehnig AC, Middelbeek RJW, Richard JJ, So K, Chen EY, Gao F, Narain NR, Distefano G, Shettigar VK, Hirshman MF, Ziolo MT, Kiebish MA, Tseng YH, Coen PM, Goodyear LJ. 12,13-diHOME: An Exercise-Induced Lipokine that Increases Skeletal Muscle Fatty Acid Uptake. Cell Metab. 2018 May 1;27(5):1111-1120.e3. doi: 10.1016/j.cmet.2018.03.020.
PubMed 29719226Lynes MD, Leiria LO, Lundh M, Bartelt A, Shamsi F, Huang TL, Takahashi H, Hirshman MF, Schlein C, Lee A, Baer LA, May FJ, Gao F, Narain NR, Chen EY, Kiebish MA, Cypess AM, Bluher M, Goodyear LJ, Hotamisligil GS, Stanford KI, Tseng YH. The cold-induced lipokine 12,13-diHOME promotes fatty acid transport into brown adipose tissue. Nat Med. 2017 May;23(5):631-637. doi: 10.1038/nm.4297. Epub 2017 Mar 27.
PubMed 28346411Rothwell NJ, Stock MJ. Effects of age on diet-induced thermogenesis and brown adipose tissue metabolism in the rat. Int J Obes. 1983;7(6):583-9.
PubMed 6686217Graja A, Schulz TJ. Mechanisms of aging-related impairment of brown adipocyte development and function. Gerontology. 2015;61(3):211-7. doi: 10.1159/000366557. Epub 2014 Dec 20.
PubMed 25531079Yazdanyar A, Newman AB. The burden of cardiovascular disease in the elderly: morbidity, mortality, and costs. Clin Geriatr Med. 2009 Nov;25(4):563-77, vii. doi: 10.1016/j.cger.2009.07.007.
PubMed 19944261
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- BAT as a Therapeutic for the Metabolic and Cardiac Dysfunction With Senescence Pilot
- ClinicalTrials.gov ID
- NCT03793127
- Acronym / sponsor ID
- BATSP / TRIMD 1344107
- Conditions
- Aging
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 24 participants (actual)
- Lead sponsor
- AdventHealth Translational Research InstituteUniversity, hospital or other
- Study start
- 23 Jan 2019 (actual)
- Primary completion
- 13 May 2019 (actual)
- Study completion
- Dec 2025 (estimated)
- First posted
- 4 Jan 2019 (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.
The primary purpose of this protocol is to develop a reliable method to determine BAT mass in young and older adults by magnetic resonance imaging.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Young group | – | Other: Maximal oxygen consumption (V02 max), Other: Brown adipose tissue (BAT) imaging, Other: Muscle function testing20-40 years of age |
| Old group | – | Other: Maximal oxygen consumption (V02 max), Other: Brown adipose tissue (BAT) imaging, Other: Muscle function testing60-80 years of age |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Males and females in the age ranges 20-40 and 60-80 years were recruited. Potential participants were medically screened to determine good health, weight stable (no gain/loss of ≥ 10 lbs in 6 months prior to screening), and without any contraindication to exercise. Approximately equal numbers of men and women will be recruited. Neither race nor ethnicity were exclusions.
Key inclusion criteria (5 listed)
- Capable of providing informed consent and has voluntarily signed and dated an informed consent form, approved by an Institutional Review Board and provided Health Insurance Portability and Accountability Act authorization (HIPAA) or other privacy authorization prior to any participation in study.
- Adult female or male, 20-40 or 60-80 years of age, inclusive at time of screening.
- BMI ≥19.0 and ≤34.9 kg/m2, inclusive at time of screening.
- Stable weight (No gain/loss of ≥ 10 lbs within 6 months prior to screening).
- Non-smokers as defined by not smoked any tobacco or nicotine-containing products vape pens or vaporizers within 3 months prior to screening.
Key exclusion criteria (23 listed)
- History of type 1 or type 2 diabetes per self-report at screening visit 1; or Hgb A1c ≥ 6.5% at screening..
- Actively pursuing weight loss and/or lifestyle changes at time of screening.
- Weight > 450 lbs at screening.
- Uncontrolled hypertension (BP >160 mmHg systolic or >100 mmHg diastolic).
- Mini Mental State Exam (MMSE) <21, only applicable for those 60-80 years of age
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Maximal oxygen consumption (V02 max)Aerobic fitness will be determined by measuring V02 max during a stationary bicycle exercise test. | Other | Old group, Young group |
| Brown adipose tissue (BAT) imagingBrown adipose tissue will be differentiated from white adipose tissue using fat fraction and T2* relaxation time maps generated from a commercially available modified 6-point Dixon (mDixon) water-fat separation method. | Other | Old group, Young group |
| Muscle function testingThis test will be done on a machine called a Biodex. We will measure the speed at which subjects move resistance at different percentages of their peak strength. | Other | Old group, Young group |
Primary outcome
Collection of imaging of BAT by magnetic resonance imaging from 10 participants in each of young and old study groups.
Time frame: 30 minutes
Brown adipose tissue will be differentiated from white adipose tissue using fat fraction and T2* relaxation time maps generated from a commercially available modified 6-point Dixon (mDixon) water-fat separation method. The participant may be removed from the magnet and repositioned during the exam in order to determine the same day variability of this method.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2025.
- Background: PubMed 19454641Kodama S, Saito K, Tanaka S, Maki M, Yachi Y, Asumi M, Sugawara A, Totsuka K, Shimano H, Ohashi Y, Yamada N, Sone H. Cardiorespiratory fitness as a quantitative predictor of all-cause mortality and cardiovascular events in healthy men and women: a meta-analysis. JAMA. 2009 May 20;301(19):2024-35. doi: 10.1001/jama.2009.681.
- Background: PubMed 26391109Costantino S, Paneni F, Cosentino F. Ageing, metabolism and cardiovascular disease. J Physiol. 2016 Apr 15;594(8):2061-73. doi: 10.1113/JP270538. Epub 2015 Oct 22.
- Background: PubMed 23702405Kalyani RR, Egan JM. Diabetes and altered glucose metabolism with aging. Endocrinol Metab Clin North Am. 2013 Jun;42(2):333-47. doi: 10.1016/j.ecl.2013.02.010. Epub 2013 Mar 22.
- Background: PubMed 19357406Cypess AM, Lehman S, Williams G, Tal I, Rodman D, Goldfine AB, Kuo FC, Palmer EL, Tseng YH, Doria A, Kolodny GM, Kahn CR. Identification and importance of brown adipose tissue in adult humans. N Engl J Med. 2009 Apr 9;360(15):1509-17. doi: 10.1056/NEJMoa0810780.
- Background: PubMed 19357405van Marken Lichtenbelt WD, Vanhommerig JW, Smulders NM, Drossaerts JM, Kemerink GJ, Bouvy ND, Schrauwen P, Teule GJ. Cold-activated brown adipose tissue in healthy men. N Engl J Med. 2009 Apr 9;360(15):1500-8. doi: 10.1056/NEJMoa0808718.
- Background: PubMed 19401428Saito M, Okamatsu-Ogura Y, Matsushita M, Watanabe K, Yoneshiro T, Nio-Kobayashi J, Iwanaga T, Miyagawa M, Kameya T, Nakada K, Kawai Y, Tsujisaki M. High incidence of metabolically active brown adipose tissue in healthy adult humans: effects of cold exposure and adiposity. Diabetes. 2009 Jul;58(7):1526-31. doi: 10.2337/db09-0530. Epub 2009 Apr 28.
- Background: PubMed 23221344Stanford KI, Middelbeek RJ, Townsend KL, An D, Nygaard EB, Hitchcox KM, Markan KR, Nakano K, Hirshman MF, Tseng YH, Goodyear LJ. Brown adipose tissue regulates glucose homeostasis and insulin sensitivity. J Clin Invest. 2013 Jan;123(1):215-23. doi: 10.1172/JCI62308. Epub 2012 Dec 10.
- Background: PubMed 25754609Berbee JF, Boon MR, Khedoe PP, Bartelt A, Schlein C, Worthmann A, Kooijman S, Hoeke G, Mol IM, John C, Jung C, Vazirpanah N, Brouwers LP, Gordts PL, Esko JD, Hiemstra PS, Havekes LM, Scheja L, Heeren J, Rensen PC. Brown fat activation reduces hypercholesterolaemia and protects from atherosclerosis development. Nat Commun. 2015 Mar 10;6:6356. doi: 10.1038/ncomms7356.
- Background: PubMed 22315305Gunawardana SC, Piston DW. Reversal of type 1 diabetes in mice by brown adipose tissue transplant. Diabetes. 2012 Mar;61(3):674-82. doi: 10.2337/db11-0510. Epub 2012 Feb 7.
- Background: PubMed 25968336Thoonen R, Ernande L, Cheng J, Nagasaka Y, Yao V, Miranda-Bezerra A, Chen C, Chao W, Panagia M, Sosnovik DE, Puppala D, Armoundas AA, Hindle A, Bloch KD, Buys ES, Scherrer-Crosbie M. Functional brown adipose tissue limits cardiomyocyte injury and adverse remodeling in catecholamine-induced cardiomyopathy. J Mol Cell Cardiol. 2015 Jul;84:202-11. doi: 10.1016/j.yjmcc.2015.05.002. Epub 2015 May 9.
- Background: PubMed 29719226Stanford KI, Lynes MD, Takahashi H, Baer LA, Arts PJ, May FJ, Lehnig AC, Middelbeek RJW, Richard JJ, So K, Chen EY, Gao F, Narain NR, Distefano G, Shettigar VK, Hirshman MF, Ziolo MT, Kiebish MA, Tseng YH, Coen PM, Goodyear LJ. 12,13-diHOME: An Exercise-Induced Lipokine that Increases Skeletal Muscle Fatty Acid Uptake. Cell Metab. 2018 May 1;27(5):1111-1120.e3. doi: 10.1016/j.cmet.2018.03.020.
- Background: PubMed 28346411Lynes MD, Leiria LO, Lundh M, Bartelt A, Shamsi F, Huang TL, Takahashi H, Hirshman MF, Schlein C, Lee A, Baer LA, May FJ, Gao F, Narain NR, Chen EY, Kiebish MA, Cypess AM, Bluher M, Goodyear LJ, Hotamisligil GS, Stanford KI, Tseng YH. The cold-induced lipokine 12,13-diHOME promotes fatty acid transport into brown adipose tissue. Nat Med. 2017 May;23(5):631-637. doi: 10.1038/nm.4297. Epub 2017 Mar 27.
- Individual participant dataSharing planned: No
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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.
Paul Coen, PhD principal investigator
Study principal investigator
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 Aging, run by AdventHealth Translational Research Institute 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 5 inclusion and 23 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: under way, not looking for participants, as of the sponsor's last update on 11 Jun 2025. 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?
This study is still under way. Results are not available in the source record yet.
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?
Collection of imaging of BAT by magnetic resonance imaging from 10 participants in each of young and old study groups. (time frame: 30 minutes). 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 NCT03793127, which also lists 19 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 11 Jun 2025.