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Not yet recruiting NCT07617649

Laboratory Heat Biomarker and Cooling Interventions

No phase Interventional Hyperthermia

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Hand cooling table, Cooling bandana.
Who it may be relevant to
Registry conditions: Hyperthermia. Basic parameters: 18 years — 50 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Laboratory Based Identification of Heat Stress Biomarkers and Effective Cooling Interventions

Overview

Our study has two goals. The first goal is to find a blood test that can detect signs of strain from heat in the body ("a biomarker"). Second, the study team wants to identify types of devices that can help people cool down quickly. By identifying biomarkers for heat strain, scientists can better track and treat the health effects of heat. The study team will identify such biomarkers by simulating, in a laboratory-based environment, the heat and physical work that real-world workers experience. In addition, the study team plans to test two cooling technologies that might keep people cool during physical activity.

Interventions

  • Other Hand cooling table
    A participant can rest their hand on the cooling table after the one hour exercise session, and this should cool their body quickly. Cold water is pumped throughout the cooling table.
  • Other Cooling bandana
    A participant will tie a bandana that has been soaked in cold water onto their forehead. They will wear this bandana during the one hour exercise session.

Primary outcome measures

  • Core body temperature [Time frame: Baseline through end of study (approximately 2 months).]

Eligibility criteria

Inclusion criteria

  • Age 18-50
  • Able to communicate in English or Spanish
  • General good health
  • A lifestyle that includes regular patterns of modest exercise
  • Body weight over 80 pounds

Exclusion criteria

  • Cannot provide informed consent
  • Known history of cardiac arrhythmias or having a pacemaker
  • Difficulty swallowing pills
  • Planned upcoming X-ray tests or MRI
  • Known history of gastroparesis, diverticulosis or diverticulitis, or inflammatory bowel disease
  • Previous surgery on stomach or intestines (except for appendix or gallbladder)
  • Pregnancy
  • Self-reported cardiac, kidney, or pulmonary disease, or diabetes
  • Concurrent use of temperature- or inflammation-modulating medications such as steroids or non-steroidal anti-inflammatory drugs (NSAIDs)
  • Staff under the direct supervision of any project directors or employed in the laboratory of the study investigators

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Crossover
Masking
Open label
Primary purpose
Prevention

Study locations

United States · 1 center
  • Stanford University — Stanford

Publications

  • Ray SC, Mason J, O'Connor PM. Ischemic Renal Injury: Can Renal Anatomy and Associated Vascular Congestion Explain Why the Medulla and Not the Cortex Is Where the Trouble Starts? Semin Nephrol. 2019 Nov;39(6):520-529. doi: 10.1016/j.semnephrol.2019.10.002. PMID 31836035
  • Evans RG, Smith DW, Lee CJ, Ngo JP, Gardiner BS. What Makes the Kidney Susceptible to Hypoxia? Anat Rec (Hoboken). 2020 Oct;303(10):2544-2552. doi: 10.1002/ar.24260. Epub 2019 Sep 30. PMID 31566903
  • Febbraio MA. Alterations in energy metabolism during exercise and heat stress. Sports Med. 2001;31(1):47-59. doi: 10.2165/00007256-200131010-00004. PMID 11219501
  • Hymczak H, Golab A, Mendrala K, Plicner D, Darocha T, Podsiadlo P, Hudziak D, Gocol R, Kosinski S. Core Temperature Measurement-Principles of Correct Measurement, Problems, and Complications. Int J Environ Res Public Health. 2021 Oct 10;18(20):10606. doi: 10.3390/ijerph182010606. PMID 34682351
  • Mazloumi A, Golbabaei F, Mahmood Khani S, Kazemi Z, Hosseini M, Abbasinia M, Farhang Dehghan S. Evaluating Effects of Heat Stress on Cognitive Function among Workers in a Hot Industry. Health Promot Perspect. 2014 Dec 30;4(2):240-6. doi: 10.5681/hpp.2014.031. eCollection 2014. PMID 25649311
  • Yin B, Fang W, Liu L, Guo Y, Ma X, Di Q. Effect of extreme high temperature on cognitive function at different time scales: A national difference-in-differences analysis. Ecotoxicol Environ Saf. 2024 Apr 15;275:116238. doi: 10.1016/j.ecoenv.2024.116238. Epub 2024 Mar 21. PMID 38518609
  • Alahmad B, Kessler W, Alwadi Y, Schwartz J, Wagner GR, Michaels D. A nationwide analysis of heat and workplace injuries in the United States. Environ Health. 2025 Oct 6;24(1):65. doi: 10.1186/s12940-025-01231-1. PMID 41047384
  • McTavish RK, Richard L, McArthur E, Shariff SZ, Acedillo R, Parikh CR, Wald R, Wilk P, Garg AX. Association Between High Environmental Heat and Risk of Acute Kidney Injury Among Older Adults in a Northern Climate: A Matched Case-Control Study. Am J Kidney Dis. 2018 Feb;71(2):200-208. doi: 10.1053/j.ajkd.2017.07.011. Epub 2017 Oct 23. PMID 29074166

Identifiers

NCT: NCT07617649 · 86182 · 1R01DK146310-01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗