Exercise Intensity and Postprandial Effects of Breaking Sedentary Behavior in Overweight Adults

NCT07229963 | Not Yet Recruiting

• 1 other identifier: SBA 25/679
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is twofold: (1) to determine whether breaking up prolonged sitting with aerobic or sprint cycling breaks reduces postprandial blood glucose, insulin, CRP, and blood pressure, which are established risk markers for cardiometabolic diseases; and (2) to assess substrate oxidation during this period in order to identify which exercise condition promotes the greatest increase in fat oxidation.

Conditions

Cardiovascular Risk Markers; Substrate Oxidation; Postprandial Metabolism; Exercise Physiology

Keywords

Exercise; Sedentary behavior; Cardiometabolic health; Postprandial metabolism; overweight

Outcome Measures

Primary Outcomes (1)

• Insulin

  Postprandial insulin. Net incremental area under the curve and total area under the curve for each 7 h condition will be calculated for insulin.

  7 hour for each experimental condition

Secondary Outcomes (4)

• Glucose

  7 hour for each experimental condition

• CRP

  7 hour

• Substrate oxidation

  0, 2th, 5th, 7th hours

• Blood pressure

  7 hour

Study Arms (3)

Sedentary: Participants will remain seated for 7 h.

EXPERIMENTAL

The sedentary condition will take place in a seated position. During the seated condition, volunteers will be seated at a typical desk chair at an appropriate height with hip and knee angles of \~90° and feet flat on the floor. The seating area will include a standard desk chair, a work desk, and the volunteers' personal laptops. Volunteers will be instructed prior to the visit to avoid behaviors such as fidgeting, excessive leg movements, and crossing their legs to minimize potential extraneous effects.

Other: Sedentary Behaviour Intervention

Breaking up sitting with aerobic exercise interruptions

EXPERIMENTAL

The protocol that will interrupt sitting with AEI will involve cycle exercises performed at 50% of VO2max for 2 minutes. The W and rpm levels corresponding to 50% of VO2max will be determined using the values recorded during the determination of VO2max.

Other: Aerobic Exercise Intervention

Breaking up sitting with sprint exercise interruptions

EXPERIMENTAL

The protocol that will interrupt sitting with SEI will involve cycle exercises performed at the maximum revolutions per minute achievable within 10 seconds. Immediately before each SEI, volunteers will increase their pedal cadence to the maximum speed they can achieve, after which a pedal load will be applied to the bicycle ergometer and a sprint will be performed against the applied load for 10 seconds. During each sprint, the pedal load will be applied at 0.065 kilograms per kilogram of lean body mass. Since it has been shown to lead to greater peak power output in overweight and obese groups, lean body mass will be used as a reference when determining pedal load, rather than total body mass.

Other: Sprint Exercise Intervention

Interventions

Aerobic Exercise Intervention OTHER

In the aerobic exercise condition, participants will perform 2 minutes of moderate-intensity continuous cycling.

Breaking up sitting with aerobic exercise interruptions

Sprint Exercise Intervention OTHER

In the sprint condition, participants will complete a 10-second all-out sprint, as determined during the preliminary test.

Breaking up sitting with sprint exercise interruptions

Sedentary Behaviour Intervention OTHER

Participants will remain seated for a total duration of 7 hours. During this period, they will be instructed to minimize excessive movement and will only be permitted to rise from the chair for voiding purposes.

Sedentary: Participants will remain seated for 7 h.

Eligibility Criteria

• Age: 35 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Being physically inactive (not doing at least 150 minutes/week of structured exercise).
• Having a physical activity level of \<5000 steps/day.
• Having a BMI between 25 and 29.9 kg/m2.
• Having a history of regular menstrual cycles for female participants.
• Having medical examination approval.

You may not qualify if:

• Taking any acute or chronic medication or supplement that may affect metabolism.
• Having an acute or chronic illness that limits exercise (musculoskeletal problems, cardiovascular disorders, respiratory problems, etc.).
• Consuming tobacco products.
• Meeting 3 or more of the metabolic syndrome criteria (waist circumference of 102 cm or more in men, 88 cm or more in women, triglyceride level of 150 mg/dL or higher, HDL cholesterol level below 40 mg/dL in men and 50 mg/dL in women, blood pressure of 130/85 mmHg or higher, fasting blood glucose level of 100 mg/dL (5.6 mg/L) or higher).

Sponsors & Collaborators

• Hacettepe University: lead

Study Sites (1)

Hacettepe Sports Science Faculty, Hacettepe Beytepe Clinic

Ankara, Beytepe, Turkey (Türkiye)

Location

Related Publications (51)

• Compher C, Frankenfield D, Keim N, Roth-Yousey L; Evidence Analysis Working Group. Best practice methods to apply to measurement of resting metabolic rate in adults: a systematic review. J Am Diet Assoc. 2006 Jun;106(6):881-903. doi: 10.1016/j.jada.2006.02.009.

  PMID: 16720129 BACKGROUND

• Frayn KN. Calculation of substrate oxidation rates in vivo from gaseous exchange. J Appl Physiol Respir Environ Exerc Physiol. 1983 Aug;55(2):628-34. doi: 10.1152/jappl.1983.55.2.628.

  PMID: 6618956 BACKGROUND

• DeMers D, Wachs D. Physiology, Mean Arterial Pressure. 2023 Apr 10. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2025 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK538226/

  PMID: 30855814 BACKGROUND

• Stergiou GS, Palatini P, Parati G, O'Brien E, Januszewicz A, Lurbe E, Persu A, Mancia G, Kreutz R; European Society of Hypertension Council and the European Society of Hypertension Working Group on Blood Pressure Monitoring and Cardiovascular Variability. 2021 European Society of Hypertension practice guidelines for office and out-of-office blood pressure measurement. J Hypertens. 2021 Jul 1;39(7):1293-1302. doi: 10.1097/HJH.0000000000002843. No abstract available.

  PMID: 33710173 BACKGROUND

• Mattes RD, Campbell WW. Effects of food form and timing of ingestion on appetite and energy intake in lean young adults and in young adults with obesity. J Am Diet Assoc. 2009 Mar;109(3):430-7. doi: 10.1016/j.jada.2008.11.031.

  PMID: 19248858 BACKGROUND

• Augustin LSA, Kendall CWC, Jenkins DJA, Willett WC, Astrup A, Barclay AW, Bjorck I, Brand-Miller JC, Brighenti F, Buyken AE, Ceriello A, La Vecchia C, Livesey G, Liu S, Riccardi G, Rizkalla SW, Sievenpiper JL, Trichopoulou A, Wolever TMS, Baer-Sinnott S, Poli A. Glycemic index, glycemic load and glycemic response: An International Scientific Consensus Summit from the International Carbohydrate Quality Consortium (ICQC). Nutr Metab Cardiovasc Dis. 2015 Sep;25(9):795-815. doi: 10.1016/j.numecd.2015.05.005. Epub 2015 May 16.

  PMID: 26160327 BACKGROUND

• Diet, nutrition and the prevention of chronic diseases. World Health Organ Tech Rep Ser. 2003;916:i-viii, 1-149, backcover.

  PMID: 12768890 BACKGROUND

• Mifflin MD, St Jeor ST, Hill LA, Scott BJ, Daugherty SA, Koh YO. A new predictive equation for resting energy expenditure in healthy individuals. Am J Clin Nutr. 1990 Feb;51(2):241-7. doi: 10.1093/ajcn/51.2.241.

  PMID: 2305711 BACKGROUND

• Carrillo-Arango HA, Atencio-Osorio MA, Lopez-Alban CA, Nava-Gonzalez EJ, Correa-Rodriguez M, Izquierdo M, Ramirez-Velez R. Metabolic responses to acute sprint interval exercise training performed after an oral 75-gram glucose load in individuals with overweight/obesity. Physiol Rep. 2023 Jan;11(2):e15555. doi: 10.14814/phy2.15555.

  PMID: 36695728 BACKGROUND

• Ramirez-Velez R, Carrillo-Arango HA, Atencio-Osorio MA, Lopez-Alban CA, Calderon-Gonzalez JC, Morales-Alamo D, Izquierdo M, Correa-Rodriguez M. No sex differences in systemic metabolic responses to acute sprint interval training performed after an oral 75-g glucose load in adults with excess adiposity. Clin Nutr ESPEN. 2025 Feb;65:25-35. doi: 10.1016/j.clnesp.2024.11.005. Epub 2024 Nov 17.

  PMID: 39551347 BACKGROUND

• Baker JS, Davies B. Brief high-intensity exercise and resistive force selection in overweight and obese subjects: body mass or body composition? Res Sports Med. 2006 Apr-Jun;14(2):97-106. doi: 10.1080/15438620600651298.

  PMID: 16869135 BACKGROUND

• Borg GA. Psychophysical bases of perceived exertion. Med Sci Sports Exerc. 1982;14(5):377-81.

  PMID: 7154893 BACKGROUND

• Midgley AW, McNaughton LR, Polman R, Marchant D. Criteria for determination of maximal oxygen uptake: a brief critique and recommendations for future research. Sports Med. 2007;37(12):1019-28. doi: 10.2165/00007256-200737120-00002.

  PMID: 18027991 BACKGROUND

• Lanzi S, Codecasa F, Cornacchia M, Maestrini S, Salvadori A, Brunani A, Malatesta D. Fat oxidation, hormonal and plasma metabolite kinetics during a submaximal incremental test in lean and obese adults. PLoS One. 2014 Feb 11;9(2):e88707. doi: 10.1371/journal.pone.0088707. eCollection 2014.

  PMID: 24523934 BACKGROUND

• Tudor-Locke C, Craig CL, Thyfault JP, Spence JC. A step-defined sedentary lifestyle index: <5000 steps/day. Appl Physiol Nutr Metab. 2013 Feb;38(2):100-14. doi: 10.1139/apnm-2012-0235. Epub 2012 Nov 8.

  PMID: 23438219 BACKGROUND

• Schmidt MD, Cleland VJ, Shaw K, Dwyer T, Venn AJ. Cardiometabolic risk in younger and older adults across an index of ambulatory activity. Am J Prev Med. 2009 Oct;37(4):278-84. doi: 10.1016/j.amepre.2009.05.020.

  PMID: 19765498 BACKGROUND

• Ekmekcioglu C, Touitou Y. Chronobiological aspects of food intake and metabolism and their relevance on energy balance and weight regulation. Obes Rev. 2011 Jan;12(1):14-25. doi: 10.1111/j.1467-789X.2010.00716.x.

  PMID: 20122134 BACKGROUND

• Alberti KG, Zimmet P, Shaw J; IDF Epidemiology Task Force Consensus Group. The metabolic syndrome--a new worldwide definition. Lancet. 2005 Sep 24-30;366(9491):1059-62. doi: 10.1016/S0140-6736(05)67402-8. No abstract available.

  PMID: 16182882 BACKGROUND

• Parolin ML, Chesley A, Matsos MP, Spriet LL, Jones NL, Heigenhauser GJ. Regulation of skeletal muscle glycogen phosphorylase and PDH during maximal intermittent exercise. Am J Physiol. 1999 Nov;277(5):E890-900. doi: 10.1152/ajpendo.1999.277.5.E890.

  PMID: 10567017 BACKGROUND

• Jensen J, Jebens E, Brennesvik EO, Ruzzin J, Soos MA, Engebretsen EM, O'Rahilly S, Whitehead JP. Muscle glycogen inharmoniously regulates glycogen synthase activity, glucose uptake, and proximal insulin signaling. Am J Physiol Endocrinol Metab. 2006 Jan;290(1):E154-E162. doi: 10.1152/ajpendo.00330.2005. Epub 2005 Aug 23.

  PMID: 16118249 BACKGROUND

• Derave W, Hansen BF, Lund S, Kristiansen S, Richter EA. Muscle glycogen content affects insulin-stimulated glucose transport and protein kinase B activity. Am J Physiol Endocrinol Metab. 2000 Nov;279(5):E947-55. doi: 10.1152/ajpendo.2000.279.5.E947.

  PMID: 11052948 BACKGROUND

• Casey A, Constantin-Teodosiu D, Howell S, Hultman E, Greenhaff PL. Metabolic response of type I and II muscle fibers during repeated bouts of maximal exercise in humans. Am J Physiol. 1996 Jul;271(1 Pt 1):E38-43. doi: 10.1152/ajpendo.1996.271.1.E38.

  PMID: 8760079 BACKGROUND

• Holloszy JO. Exercise-induced increase in muscle insulin sensitivity. J Appl Physiol (1985). 2005 Jul;99(1):338-43. doi: 10.1152/japplphysiol.00123.2005.

  PMID: 16036907 BACKGROUND

• Devlin JT, Hirshman M, Horton ED, Horton ES. Enhanced peripheral and splanchnic insulin sensitivity in NIDDM men after single bout of exercise. Diabetes. 1987 Apr;36(4):434-9. doi: 10.2337/diab.36.4.434.

  PMID: 3102297 BACKGROUND

• Gibala MJ, Little JP. Physiological basis of brief vigorous exercise to improve health. J Physiol. 2020 Jan;598(1):61-69. doi: 10.1113/JP276849. Epub 2019 Dec 20.

  PMID: 31691289 BACKGROUND

• Cochran AJ, Percival ME, Tricarico S, Little JP, Cermak N, Gillen JB, Tarnopolsky MA, Gibala MJ. Intermittent and continuous high-intensity exercise training induce similar acute but different chronic muscle adaptations. Exp Physiol. 2014 May 1;99(5):782-91. doi: 10.1113/expphysiol.2013.077453. Epub 2014 Feb 14.

  PMID: 24532598 BACKGROUND

• Bogdanis GC, Nevill ME, Lakomy HK, Boobis LH. Power output and muscle metabolism during and following recovery from 10 and 20 s of maximal sprint exercise in humans. Acta Physiol Scand. 1998 Jul;163(3):261-72. doi: 10.1046/j.1365-201x.1998.00378.x.

  PMID: 9715738 BACKGROUND

• Sabag A, Little JP, Johnson NA. Low-volume high-intensity interval training for cardiometabolic health. J Physiol. 2022 Mar;600(5):1013-1026. doi: 10.1113/JP281210. Epub 2021 Apr 18.

  PMID: 33760255 BACKGROUND

• Dunstan DW, Kingwell BA, Larsen R, Healy GN, Cerin E, Hamilton MT, Shaw JE, Bertovic DA, Zimmet PZ, Salmon J, Owen N. Breaking up prolonged sitting reduces postprandial glucose and insulin responses. Diabetes Care. 2012 May;35(5):976-83. doi: 10.2337/dc11-1931. Epub 2012 Feb 28.

  PMID: 22374636 BACKGROUND

• Dey KC, Zakrzewski-Fruer JK, Smith LR, Jones RL, Bailey DP. Interrupting sitting acutely attenuates cardiometabolic risk markers in South Asian adults living with overweight and obesity. Eur J Appl Physiol. 2024 Apr;124(4):1163-1174. doi: 10.1007/s00421-023-05345-7. Epub 2023 Nov 11.

  PMID: 37950762 BACKGROUND

• Larsen RN, Kingwell BA, Sethi P, Cerin E, Owen N, Dunstan DW. Breaking up prolonged sitting reduces resting blood pressure in overweight/obese adults. Nutr Metab Cardiovasc Dis. 2014 Sep;24(9):976-82. doi: 10.1016/j.numecd.2014.04.011. Epub 2014 May 2.

  PMID: 24875670 BACKGROUND

• Wongpipit W, Zhang X, Miyashita M, Wong SH. Interrupting Prolonged Sitting Reduces Postprandial Glucose Concentration in Young Men With Central Obesity. J Clin Endocrinol Metab. 2021 Jan 23;106(2):e791-e802. doi: 10.1210/clinem/dgaa834.

  PMID: 33186451 BACKGROUND

• Peddie MC, Bone JL, Rehrer NJ, Skeaff CM, Gray AR, Perry TL. Breaking prolonged sitting reduces postprandial glycemia in healthy, normal-weight adults: a randomized crossover trial. Am J Clin Nutr. 2013 Aug;98(2):358-66. doi: 10.3945/ajcn.112.051763. Epub 2013 Jun 26.

  PMID: 23803893 BACKGROUND

• Benatti FB, Ried-Larsen M. The Effects of Breaking up Prolonged Sitting Time: A Review of Experimental Studies. Med Sci Sports Exerc. 2015 Oct;47(10):2053-61. doi: 10.1249/MSS.0000000000000654.

  PMID: 26378942 BACKGROUND

• Loh R, Stamatakis E, Folkerts D, Allgrove JE, Moir HJ. Effects of Interrupting Prolonged Sitting with Physical Activity Breaks on Blood Glucose, Insulin and Triacylglycerol Measures: A Systematic Review and Meta-analysis. Sports Med. 2020 Feb;50(2):295-330. doi: 10.1007/s40279-019-01183-w.

  PMID: 31552570 BACKGROUND

• Cavalot F, Petrelli A, Traversa M, Bonomo K, Fiora E, Conti M, Anfossi G, Costa G, Trovati M. Postprandial blood glucose is a stronger predictor of cardiovascular events than fasting blood glucose in type 2 diabetes mellitus, particularly in women: lessons from the San Luigi Gonzaga Diabetes Study. J Clin Endocrinol Metab. 2006 Mar;91(3):813-9. doi: 10.1210/jc.2005-1005. Epub 2005 Dec 13.

  PMID: 16352690 BACKGROUND

• Monnier L, Mas E, Ginet C, Michel F, Villon L, Cristol JP, Colette C. Activation of oxidative stress by acute glucose fluctuations compared with sustained chronic hyperglycemia in patients with type 2 diabetes. JAMA. 2006 Apr 12;295(14):1681-7. doi: 10.1001/jama.295.14.1681.

  PMID: 16609090 BACKGROUND

• Pappas C, Kandaraki EA, Tsirona S, Kountouras D, Kassi G, Diamanti-Kandarakis E. Postprandial dysmetabolism: Too early or too late? Hormones (Athens). 2016 Jul;15(3):321-344. doi: 10.14310/horm.2002.1697.

  PMID: 27838603 BACKGROUND

• O'Keefe JH, Bell DS. Postprandial hyperglycemia/hyperlipidemia (postprandial dysmetabolism) is a cardiovascular risk factor. Am J Cardiol. 2007 Sep 1;100(5):899-904. doi: 10.1016/j.amjcard.2007.03.107. Epub 2007 Jun 26.

  PMID: 17719342 BACKGROUND

• Trost SG, Owen N, Bauman AE, Sallis JF, Brown W. Correlates of adults' participation in physical activity: review and update. Med Sci Sports Exerc. 2002 Dec;34(12):1996-2001. doi: 10.1097/00005768-200212000-00020.

  PMID: 12471307 BACKGROUND

• Akins JD, Crawford CK, Burton HM, Wolfe AS, Vardarli E, Coyle EF. Inactivity induces resistance to the metabolic benefits following acute exercise. J Appl Physiol (1985). 2019 Apr 1;126(4):1088-1094. doi: 10.1152/japplphysiol.00968.2018. Epub 2019 Feb 14.

  PMID: 30763169 BACKGROUND

• Ekelund U, Steene-Johannessen J, Brown WJ, Fagerland MW, Owen N, Powell KE, Bauman A, Lee IM; Lancet Physical Activity Series 2 Executive Committe; Lancet Sedentary Behaviour Working Group. Does physical activity attenuate, or even eliminate, the detrimental association of sitting time with mortality? A harmonised meta-analysis of data from more than 1 million men and women. Lancet. 2016 Sep 24;388(10051):1302-10. doi: 10.1016/S0140-6736(16)30370-1. Epub 2016 Jul 28.

  PMID: 27475271 BACKGROUND

• Piercy KL, Troiano RP, Ballard RM, Carlson SA, Fulton JE, Galuska DA, George SM, Olson RD. The Physical Activity Guidelines for Americans. JAMA. 2018 Nov 20;320(19):2020-2028. doi: 10.1001/jama.2018.14854.

  PMID: 30418471 BACKGROUND

• DiPietro L, Al-Ansari SS, Biddle SJH, Borodulin K, Bull FC, Buman MP, Cardon G, Carty C, Chaput JP, Chastin S, Chou R, Dempsey PC, Ekelund U, Firth J, Friedenreich CM, Garcia L, Gichu M, Jago R, Katzmarzyk PT, Lambert E, Leitzmann M, Milton K, Ortega FB, Ranasinghe C, Stamatakis E, Tiedemann A, Troiano RP, van der Ploeg HP, Willumsen JF. Advancing the global physical activity agenda: recommendations for future research by the 2020 WHO physical activity and sedentary behavior guidelines development group. Int J Behav Nutr Phys Act. 2020 Nov 26;17(1):143. doi: 10.1186/s12966-020-01042-2.

  PMID: 33239105 BACKGROUND

• King WC, Chen JY, Courcoulas AP, Mitchell JE, Wolfe BM, Patterson EJ, Inabnet WB, Dakin GF, Flum DR, Cook B, Belle SH. Objectively-measured sedentary time and cardiometabolic health in adults with severe obesity. Prev Med. 2016 Mar;84:12-8. doi: 10.1016/j.ypmed.2015.12.007. Epub 2015 Dec 24.

  PMID: 26724517 BACKGROUND

• Honda T, Chen S, Yonemoto K, Kishimoto H, Chen T, Narazaki K, Haeuchi Y, Kumagai S. Sedentary bout durations and metabolic syndrome among working adults: a prospective cohort study. BMC Public Health. 2016 Aug 26;16(1):888. doi: 10.1186/s12889-016-3570-3.

  PMID: 27562190 BACKGROUND

• Dempsey PC, Biddle SJH, Buman MP, Chastin S, Ekelund U, Friedenreich CM, Katzmarzyk PT, Leitzmann MF, Stamatakis E, van der Ploeg HP, Willumsen J, Bull F. New global guidelines on sedentary behaviour and health for adults: broadening the behavioural targets. Int J Behav Nutr Phys Act. 2020 Nov 26;17(1):151. doi: 10.1186/s12966-020-01044-0.

  PMID: 33239026 BACKGROUND

• Pinto AJ, Bergouignan A, Dempsey PC, Roschel H, Owen N, Gualano B, Dunstan DW. Physiology of sedentary behavior. Physiol Rev. 2023 Oct 1;103(4):2561-2622. doi: 10.1152/physrev.00022.2022. Epub 2023 Jun 16.

  PMID: 37326297 BACKGROUND

• Wanner M, Richard A, Martin B, Faeh D, Rohrmann S. Associations between self-reported and objectively measured physical activity, sedentary behavior and overweight/obesity in NHANES 2003-2006. Int J Obes (Lond). 2017 Jan;41(1):186-193. doi: 10.1038/ijo.2016.168. Epub 2016 Sep 28.

  PMID: 27677618 BACKGROUND

• Prince SA, Elliott CG, Scott K, Visintini S, Reed JL. Device-measured physical activity, sedentary behaviour and cardiometabolic health and fitness across occupational groups: a systematic review and meta-analysis. Int J Behav Nutr Phys Act. 2019 Apr 2;16(1):30. doi: 10.1186/s12966-019-0790-9.

  PMID: 30940176 BACKGROUND

• Tremblay MS, Aubert S, Barnes JD, Saunders TJ, Carson V, Latimer-Cheung AE, Chastin SFM, Altenburg TM, Chinapaw MJM; SBRN Terminology Consensus Project Participants. Sedentary Behavior Research Network (SBRN) - Terminology Consensus Project process and outcome. Int J Behav Nutr Phys Act. 2017 Jun 10;14(1):75. doi: 10.1186/s12966-017-0525-8.

  PMID: 28599680 BACKGROUND

MeSH Terms

Conditions

Motor Activity; Sedentary Behavior; Overweight

Condition Hierarchy (Ancestors)

Behavior; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Şükran Nazan Koşar, Professor

  Hacettepe University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hikmet Sercan Toprakoğlu

CONTACT

+905369792652; sercantprkgl@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: September 24, 2025
• First Posted: November 17, 2025
• Study Start: November 25, 2025
• Primary Completion: April 25, 2026
• Study Completion (Estimated): June 15, 2026
• Last Updated: November 17, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)