Breath Acetone During Tirzepatide Treatment and Resistance Training in Adults With Obesity (RESIST-EXHALE)
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.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
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 de estudio
Inscripción (Estimado)
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Katharina Timper, Prof. Dr. med.
- Número de teléfono: +49 89 289 24930
- Correo electrónico: Katharina.Timper@mri.tum.de
Copia de seguridad de contactos de estudio
- Nombre: Kristina Geyer, Dr. rer. nat.
- Número de teléfono: +49 89 289 24925
- Correo electrónico: k.geyer@tum.de
Ubicaciones de estudio
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München, Alemania, 80809
- TUM Klinikum, Department for Clinical Nutritional Medicine and Department for Preventive Sports Medicine and Sports Cardiology, Am Olympiacampus 11, 80809 Munich, Germany
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Contacto:
- Katharina Timper, Prof. Dr. med.
- Número de teléfono: +49 89 289 24930
- Correo electrónico: Katharina.Timper@mri.tum.de
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
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.
Descripción
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
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Modelos observacionales: COHORT
- Perspectivas temporales: PROSPECTIVE
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
|---|---|
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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. |
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). 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. |
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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. |
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). |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Change in breath acetone concentration from baseline to end of treatment
Periodo de tiempo: Baseline (Week 0) and end of treatment (Week 24)
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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)
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Baseline breath acetone and change in body weight
Periodo de tiempo: Baseline (Week 0) to Week 24
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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
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Baseline breath acetone and change in fat mass
Periodo de tiempo: Baseline (Week 0) to Week 24
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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
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Baseline breath acetone and change in skeletal muscle mass
Periodo de tiempo: Baseline (Week 0) to Week 24
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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
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Baseline breath acetone and change in thigh muscle volume
Periodo de tiempo: Baseline (Week 0) to Week 24
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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
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Baseline breath acetone and change in knee extension strength
Periodo de tiempo: Baseline (Week 0) to Week 24
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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
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Change in breath acetone concentration from baseline to Week 4
Periodo de tiempo: Baseline (Week 0) and Week 4
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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
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Time course of breath acetone concentration during treatment
Periodo de tiempo: Week 0 to Week 24
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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
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Predictive value of early change versus baseline breath acetone for clinical response
Periodo de tiempo: Baseline (Week 0) to Week 24
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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
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Baseline breath acetone and change in handgrip strength
Periodo de tiempo: Baseline (Week 0) to Week 24
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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
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Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Trastornos Nutricionales
- Sobrenutrición
- Peso corporal
- Exceso de peso
- Condiciones Patológicas, Signos y Síntomas
- Enfermedades Nutricionales y Metabólicas
- Signos y síntomas
- Obesidad
- Aminoácidos, péptidos y proteínas
- Proteínas
- Receptor de péptido-1 tipo glucagón
- Receptores de péptidos tipo glucagón
- Receptores, acoplados a la proteína G
- Receptores, superficie celular
- Proteínas de membrana
- Receptores, hormona gastrointestinal
- Receptores, péptido
- Tirzepatide
Otros números de identificación del estudio
- 2026-537-S-CT
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan 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.
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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