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.
調査の概要
詳細な説明
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.
研究の種類
入学 (推定)
連絡先と場所
研究連絡先
- 名前：Katharina Timper, Prof. Dr. med.
- 電話番号：+49 89 289 24930
- メール：Katharina.Timper@mri.tum.de
研究連絡先のバックアップ
- 名前：Kristina Geyer, Dr. rer. nat.
- 電話番号：+49 89 289 24925
- メール：k.geyer@tum.de
研究場所
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München、ドイツ、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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コンタクト：
- Katharina Timper, Prof. Dr. med.
- 電話番号：+49 89 289 24930
- メール：Katharina.Timper@mri.tum.de
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
サンプリング方法
調査対象母集団
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.
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 観測モデル：COHORT
- 時間の展望：PROSPECTIVE
コホートと介入
グループ/コホート |
介入・治療 |
|---|---|
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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. |
|
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). |
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Change in breath acetone concentration from baseline to end of treatment
時間枠：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)
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Baseline breath acetone and change in body weight
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
|
協力者と研究者
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- 2026-537-S-CT
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
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.
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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