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

5. november 2026 oppdatert av: 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.

Studieoversikt

Status

Har ikke rekruttert ennå

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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.

Studietype

Observasjonsmessig

Registrering (Antatt)

150

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studer Kontakt Backup

  • Navn: Kristina Geyer, Dr. rer. nat.
  • Telefonnummer: +49 89 289 24925
  • E-post: k.geyer@tum.de

Studiesteder

  • Tyskland
      • München, Tyskland, 80809
        • TUM Klinikum, Department for Clinical Nutritional Medicine and Department for Preventive Sports Medicine and Sports Cardiology, Am Olympiacampus 11, 80809 Munich, Germany
        • Ta kontakt med:

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år til 60 år (Voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Prøvetakingsmetode

Ikke-sannsynlighetsprøve

Studiepopulasjon

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.

Beskrivelse

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

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Observasjonsmodeller: COHORT
  • Tidsperspektiver: PROSPECTIVE

Kohorter og intervensjoner

Gruppe / Kohort
Intervensjon / Behandling
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.
Legemiddel: 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).

Atferdsmessig: 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.
Legemiddel: 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).

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Change in breath acetone concentration from baseline to end of treatment
Tidsramme: 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)

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Baseline breath acetone and change in body weight
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Technical University of Munich

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

22. oktober 2026

Primær fullføring (Antatt)

31. juli 2027

Studiet fullført (Antatt)

31. juli 2027

Datoer for studieregistrering

Først innsendt

17. oktober 2026

Først innsendt som oppfylte QC-kriteriene

5. november 2026

Først lagt ut (Faktiske)

12. november 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

12. november 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

5. november 2026

Sist bekreftet

1. november 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • 2026-537-S-CT

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

IPD-planbeskrivelse

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.

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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