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Breath Acetone During Tirzepatide Treatment and Resistance Training in Adults With Obesity (RESIST-EXHALE)

5. listopadu 2026 aktualizováno: Technical University of Munich

Exhaled Breath Analysis for the Prediction of Treatment Response During Tirzepatide Therapy and Resistance Training in Adults With Obesity - An Ancillary Study to the RESIST Trial

This study is an ancillary study to the RESIST trial, in which adults with obesity receive the weight-loss medication tirzepatide and are randomly assigned to a structured resistance training program or to usual care for 24 weeks. RESIST-EXHALE measures acetone in exhaled breath, a non-invasive marker of fat burning, at all seven RESIST visits (Week 0 to Week 24). The study investigates how breath acetone changes during treatment, whether this change differs between participants with and without resistance training, and whether breath acetone at the start or early in treatment can predict the individual response to treatment, such as weight loss and preservation of muscle. The measurement takes about 15-20 minutes at the first visit and about 10 minutes at each later visit. No additional visits, interventions or biological samples are part of this ancillary study.

Přehled studie

Postavení

Zatím nenabíráme

Podmínky

Intervence / Léčba

Detailní popis

RESIST-EXHALE is a prospective, observational, monocentric ancillary study conducted at the TUM Klinikum, Munich, Germany. Active participation in the RESIST trial (protocol code RESIST-26-HAL-0150-I; EU CT number 2026-526200-69-00) is a prerequisite for enrolment. RESIST is a randomized, controlled, open-label Phase IV trial evaluating a structured resistance training program versus usual care in 150 adults with obesity treated with tirzepatide over 24 weeks.

RESIST-EXHALE involves no investigational medicinal product, no intervention and no randomization. Assignment to resistance training or usual care occurs exclusively within the RESIST trial. Breath acetone concentration is measured under standardized fasting conditions (at least 8 hours) at all RESIST visits (V1, Week 0; V2-V6, Weeks 4, 8, 12, 16, 20; V7, Week 24) using a handheld point-of-care breath acetone analyzer (Nutrion™, Alivion AG) with volume-controlled, end-tidal breath sampling. The device is used for research purposes only and does not inform clinical decisions. A short questionnaire on known confounders of breath acetone is completed before each measurement.

The primary endpoint is the change in breath acetone from V1 to V7, compared between arms. All analyses are exploratory and hypothesis-generating; no formal sample size calculation or multiplicity adjustment is performed.

Typ studie

Pozorovací

Zápis (Odhadovaný)

150

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní kontakt

Studijní záloha kontaktů

  • Jméno: Kristina Geyer, Dr. rer. nat.
  • Telefonní číslo: +49 89 289 24925
  • E-mail: k.geyer@tum.de

Studijní místa

  • Německo
      • München, Německo, 80809
        • TUM Klinikum, Department for Clinical Nutritional Medicine and Department for Preventive Sports Medicine and Sports Cardiology, Am Olympiacampus 11, 80809 Munich, Germany
        • Kontakt:

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

18 let až 60 let (Dospělý)

Přijímá zdravé dobrovolníky

Ne

Pohlaví způsobilá ke studiu

Všechno

Metoda odběru vzorků

Vzorek nepravděpodobnosti

Studijní populace

Participants of the RESIST trial at the TUM Klinikum, Munich: adults aged 18-60 years with obesity (BMI ≥ 30 kg/m²) without manifest type 2 diabetes or structural cardiovascular disease, eligible for pharmacological weight-loss therapy and suitable for a structured resistance training program. Sufficient command of German is required.

Popis

Inclusion Criteria:

  • Provisional eligibility for randomization into the RESIST trial (based on all RESIST screening assessments available at the time of informed consent for this ancillary study)
  • Written informed consent for this ancillary study

Exclusion Criteria:

  • Non-randomization into the RESIST trial for any reason
  • Any anatomical or functional condition preventing breath sampling through a mouthpiece (e.g., tracheostomy, laryngectomy, severe facial deformity), such that a valid end-tidal breath sample cannot be obtained

Key eligibility criteria of the RESIST trial (for context only; full criteria see RESIST protocol RESIST-26-HAL-0150-I):

  • Age 18-60 years
  • Obesity (BMI ≥ 30 kg/m²)
  • No manifest type 2 diabetes
  • No structural cardiovascular disease
  • Not pregnant or breastfeeding
  • Sufficient command of the German language

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Observační modely: COHORT
  • Časové perspektivy: PROSPECTIVE

Kohorty a intervence

Skupina / kohorta
Intervence / Léčba
Resistance training + tirzepatide

RESIST participants randomized to the structured resistance training arm of the RESIST trial, receiving tirzepatide and individualized diet and physical activity counselling. Assignment occurs within RESIST, not within this ancillary study.
Lék: Tirzepatide

Once-weekly subcutaneous injection over 24 weeks, starting at 2.5 mg/week and increased by 2.5 mg every 4 weeks as tolerated up to a maximum of 10 mg/week, in accordance with the SmPC. Administered within the RESIST trial (not part of this ancillary study).

Behaviorální: Structured resistance training

Machine-based structured resistance training over 24 weeks, delivered within the RESIST trial (not part of this ancillary study). Progressive program with an acclimation phase (weeks 1-4) and a target phase (weeks 5-24; 8-12 repetitions at approx. 70-75% 1-RM, with additional eccentric overload from week 9). Sessions are intended to be fully supervised during the first 6 weeks whenever feasible, thereafter at least one supervised session after each interim visit; remaining sessions at the trial site or at partner fitness facilities.
Usual care + tirzepatide

RESIST participants randomized to the usual care arm of the RESIST trial, receiving tirzepatide and individualized diet and physical activity counselling. Assignment occurs within RESIST, not within this ancillary study.
Lék: Tirzepatide

Once-weekly subcutaneous injection over 24 weeks, starting at 2.5 mg/week and increased by 2.5 mg every 4 weeks as tolerated up to a maximum of 10 mg/week, in accordance with the SmPC. Administered within the RESIST trial (not part of this ancillary study).

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Change in breath acetone concentration from baseline to end of treatment
Časové okno: Baseline (Week 0) and end of treatment (Week 24)

Breath acetone concentration (ppm) measured under standardized fasting conditions with a handheld point-of-care breath acetone analyzer. Change from baseline to Week 24, compared between the resistance training group and the usual care group, adjusted for baseline.
Baseline (Week 0) and end of treatment (Week 24)

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Baseline breath acetone and change in body weight
Časové okno: Baseline (Week 0) to Week 24

Regression coefficient of the percentage change in body weight (%; calibrated scale) on baseline breath acetone (ppm; handheld breath acetone analyzer)
Baseline (Week 0) to Week 24
Baseline breath acetone and change in fat mass
Časové okno: Baseline (Week 0) to Week 24

Regression coefficient of the change in fat mass (kg; bioelectrical impedance analysis) on baseline breath acetone (ppm; handheld breath acetone analyzer)
Baseline (Week 0) to Week 24
Baseline breath acetone and change in skeletal muscle mass
Časové okno: Baseline (Week 0) to Week 24

Regression coefficient of the change in skeletal muscle mass (kg; bioelectrical impedance analysis) on baseline breath acetone (ppm; handheld breath acetone analyzer)
Baseline (Week 0) to Week 24
Baseline breath acetone and change in thigh muscle volume
Časové okno: Baseline (Week 0) to Week 24

Regression coefficient of the change in contractile thigh muscle volume (mL; MRI) on baseline breath acetone (ppm; handheld breath acetone analyzer)
Baseline (Week 0) to Week 24
Baseline breath acetone and change in knee extension strength
Časové okno: Baseline (Week 0) to Week 24

Regression coefficient of the change in peak isometric knee extension torque (Nm; isokinetic dynamometer) on baseline breath acetone (ppm; handheld breath acetone analyzer)
Baseline (Week 0) to Week 24
Change in breath acetone concentration from baseline to Week 4
Časové okno: Baseline (Week 0) and Week 4

Breath acetone concentration (ppm; handheld breath acetone analyzer) under standardized fasting conditions; change from Week 0 to Week 4, compared between groups
Baseline (Week 0) and Week 4
Time course of breath acetone concentration during treatment
Časové okno: Week 0 to Week 24

Breath acetone concentration (ppm; handheld breath acetone analyzer) at Weeks 0, 4, 8, 12, 16, 20 and 24, compared between groups
Week 0 to Week 24
Predictive value of early change versus baseline breath acetone for clinical response
Časové okno: Baseline (Week 0) to Week 24

Comparative predictive value of the change in breath acetone concentration from Week 0 to Week 4 versus the baseline (Week 0) breath acetone concentration alone (ppm; handheld breath acetone analyzer) for the percentage change in body weight (%; calibrated scale) from Week 0 to Week 24 (RESIST data).
Baseline (Week 0) to Week 24
Baseline breath acetone and change in handgrip strength
Časové okno: Baseline (Week 0) to Week 24

Regression coefficient of the change in maximum handgrip strength (kg; hand dynamometer) on baseline breath acetone (ppm; handheld breath acetone analyzer)
Baseline (Week 0) to Week 24

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

Technical University of Munich

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Odhadovaný)

22. října 2026

Primární dokončení (Odhadovaný)

31. července 2027

Dokončení studie (Odhadovaný)

31. července 2027

Termíny zápisu do studia

První předloženo

17. října 2026

První předloženo, které splnilo kritéria kontroly kvality

5. listopadu 2026

První zveřejněno (Aktuální)

12. listopadu 2026

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

12. listopadu 2026

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

5. listopadu 2026

Naposledy ověřeno

1. listopadu 2026

Více informací

Termíny související s touto studií

Klíčová slova

Další relevantní podmínky MeSH

Další identifikační čísla studie

  • 2026-537-S-CT

Plán pro data jednotlivých účastníků (IPD)

Plánujete sdílet data jednotlivých účastníků (IPD)?

NE

Popis plánu IPD

Individual participant data will not be shared outside the sponsor institution. Aggregated or fully anonymized data may be made available to researchers upon reasonable request to the Principal Investigator.

Informace o lécích a zařízeních, studijní dokumenty

Studuje lékový produkt regulovaný americkým FDA

Ne

Studuje produkt zařízení regulovaný americkým úřadem FDA

Ne

Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .

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