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

5 novembre 2026 aggiornato da: 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.

Panoramica dello studio

Stato

Non ancora reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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.

Tipo di studio

Osservativo

Iscrizione (Stimato)

150

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Backup dei contatti dello studio

  • Nome: Kristina Geyer, Dr. rer. nat.
  • Numero di telefono: +49 89 289 24925
  • Email: k.geyer@tum.de

Luoghi di studio

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

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Da 18 anni a 60 anni (Adulto)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Metodo di campionamento

Campione non probabilistico

Popolazione di studio

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.

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Modelli osservazionali: COHORT
  • Prospettive temporali: PROSPECTIVE

Coorti e interventi

Gruppo / Coorte
Intervento / Trattamento
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.
Droga: 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).

Comportamentale: 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.
Droga: 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).

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change in breath acetone concentration from baseline to end of treatment
Lasso di tempo: 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)

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Baseline breath acetone and change in body weight
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Technical University of Munich

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

22 ottobre 2026

Completamento primario (Stimato)

31 luglio 2027

Completamento dello studio (Stimato)

31 luglio 2027

Date di iscrizione allo studio

Primo inviato

17 ottobre 2026

Primo inviato che soddisfa i criteri di controllo qualità

5 novembre 2026

Primo Inserito (Effettivo)

12 novembre 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

12 novembre 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

5 novembre 2026

Ultimo verificato

1 novembre 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • 2026-537-S-CT

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Descrizione del piano 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.

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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