Effectiveness of Combined GLP-1/GIP Dual Agonist Therapy and Structured Exercise on Skeletal Muscle Morphology, Quality, and Physical Function in Overweight and Obese Individuals
2026年6月3日 更新者：Özgül Öztürk、Acibadem University
Effectiveness of Combined GLP-1/GIP Dual Agonist Therapy and Structured Exercise on Skeletal Muscle Morphology, Quality, and Physical Function in Overweight and Obese Individuals: a Randomized Controlled Trial Protocol
This randomized controlled trial aims to investigate the effects of a 24-week home-based progressive resistance exercise program combined with tirzepatide treatment on skeletal muscle mass, muscle quality, and functional capacity in overweight and obese individuals.
A total of 108 participants initiating tirzepatide therapy will be randomized to either exercise plus pharmacotherapy or pharmacotherapy alone.
The primary outcome is change in thigh muscle thickness and echo intensity assessed by ultrasonography.
調査の概要
状態
まだ募集していません
詳細な説明
Pharmacologically induced weight loss with glucagon-like peptide-1 (GLP-1)/ glucose-dependent insulinotropic polypeptide (GIP) receptor agonists such as tirzepatide is associated with significant reductions in lean body mass, raising concerns regarding muscle function and long-term outcomes. Resistance exercise is the most effective intervention to preserve muscle mass during weight loss; however, evidence combining these approaches is limited.
This study is a prospective, two-center, single-blinded, randomized controlled trial designed to evaluate whether structured resistance exercise enhances muscle preservation and functional outcomes in individuals receiving tirzepatide therapy.
研究の種類
介入
入学 (推定)
108
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究連絡先
- 名前：Özgül Öztürk, Associate Professor
- 電話番号：902165004185
- メール：ozgul.ozturk@acibadem.edu.tr
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
いいえ
説明
Inclusion Criteria:
- initiation of tirzepatide-based pharmacological treatment as prescribed by an endocrinology and metabolism specialist,
- body mass index (BMI) ≥27 kg/m² and the presence of a comorbidity condition or BMI≥30 kg/m²
- age between 18 and 65 years
Exclusion Criteria:
- diagnosis of type 1 or type 2 diabetes mellitus
- presence of cerebrovascular, hematological, pulmonary, rheumatological, or neurological disorders
- current participation in a structured diet or exercise program
- use of weight-loss medications within the past 12 months
- history of upper or lower extremity surgery or injury within the past 6 months
- any contraindication to resistance exercise as determined by the treating physician.
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：Resistance Exercise + Tirzepatide
24-week home-based progressive resistance exercise program (3 sessions/week) using elastic bands and bodyweight exercises, combined with tirzepatide treatment and general lifestyle recommendations..
|
A 24-week home-based resistance exercises using elastic band and bodyweight
Lifestyle recommendations including physical activity and nutritional advice
|
|
アクティブコンパレータ：Tirzepatide Alone
Standard tirzepatide treatment with usual care and general lifestyle recommendations.
|
Lifestyle recommendations including physical activity and nutritional advice
|
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 |
|---|---|---|
|
Change in muscle thickness
時間枠：Baseline, 12 weeks, 24 weeks
|
Muscle thickness of the thigh (quadriceps femoris) will be assessed using a portable ultrasound and will be presented in millimeters (mm).
|
Baseline, 12 weeks, 24 weeks
|
|
Muscle echo intensity
時間枠：Baseline, 12 weeks, 24 weeks
|
Echo intensity will be assessed via a portable muscle ultrasonography using grayscale analysis (0-255 scale) within a standardized region of interest using ImageJ software (National Institutes of Health, USA), with higher values indicating greater intramuscular fat and fibrous tissue infiltration and thus poorer muscle quality.
Assessments will include quadriceps femoris.
|
Baseline, 12 weeks, 24 weeks
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Muscle strength (handheld dynamometer)
時間枠：Baseline, 12 weeks, 24 weeks
|
Isometric muscle strength of the biceps brachii, triceps brachii, quadriceps femoris, and hamstrings will be assessed bilaterally using a Lafayette handheld dynamometer (Lafayette Instrument Company®, USA) using the make test method.
|
Baseline, 12 weeks, 24 weeks
|
|
Body weight
時間枠：Baseline, 12 weeks, 24 weeks
|
Body weight will be assessed using bioelectrical impedance analysis and presented in kilograms (kg).
|
Baseline, 12 weeks, 24 weeks
|
|
Six-minute walk test
時間枠：Baseline, 12 weeks, 24 weeks
|
Functional capacity will be assessed using the 6-minute walk test according to standardized procedures and the total distance will be recorded in meters.
|
Baseline, 12 weeks, 24 weeks
|
|
Physical activity
時間枠：Baseline, 12 weeks, 24 weeks
|
Physical activity will be measured objectively using a wearable device (Garmin Vívosmart 5), time spent for light, moderate, and vigorous activity will be recorded for 7 days.
|
Baseline, 12 weeks, 24 weeks
|
|
Nutritional status (3-day food record)
時間枠：Baseline, 12 weeks, 24 weeks
|
Dietary intake will be assessed at baseline, 12 weeks, and 24 weeks using 3-day food records (two non-consecutive weekdays and one weekend day).
Prior to assessment, participants will receive standardized verbal, written, and visual instructions - including portion size estimation aids - to ensure accurate and consistent recording.
|
Baseline, 12 weeks, 24 weeks
|
|
Quality of life (Short Form-36)
時間枠：Baseline, 12 weeks, 24 weeks
|
The Short Form-36, a validated and reliable self-reported instrument evaluating physical and mental health status across eight domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health will be used to determine the level of quality of life.
Physical and mental sub scales are scored from 0 to 100, higher scores indicate a better quality of life.
|
Baseline, 12 weeks, 24 weeks
|
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Clinical parameters (blood pressure)
時間枠：Baseline, 12 weeks, 24 weeks
|
Blood pressure will be measured using a sphygmomanometer at each assessment point.
|
Baseline, 12 weeks, 24 weeks
|
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Height
時間枠：Baseline, 12 weeks, 24 weeks
|
Height of the participants will be assessed using a stadiometer and presented in meters.
|
Baseline, 12 weeks, 24 weeks
|
|
Body mass index
時間枠：Baseline, 12 weeks, 24 weeks
|
Body mass index will be calculated using height and weight (kg/m^2)
|
Baseline, 12 weeks, 24 weeks
|
|
Body fat percentage
時間枠：Baseline, 12 weeks, 24 weeks
|
Body fat percentage will be assessed using bioelectrical impedance analysis and presented in percentage (%).
|
Baseline, 12 weeks, 24 weeks
|
|
Fat free mass
時間枠：Baseline, 12 weeks, 24 weeks
|
Fat-free mass will be assessed using bioelectrical impedance analysis and presented in kilograms.
|
Baseline, 12 weeks, 24 weeks
|
|
Chair stand test
時間枠：Baseline, 12 weeks, 24 weeks
|
Functional capacity will be assessed using 30-second chair stand test according to standardized procedures.
The number of repetitions which the participants fully raised from a chair will be recorded in numbers (n).
|
Baseline, 12 weeks, 24 weeks
|
|
Self-reported physical activity
時間枠：Baseline, 12 weeks, 24 weeks
|
Self-reported physical activity will be determined using the International Physical Activity Questionnaire-Short Form (IPAQ-SF).
Metabolic equivalent (MET) values will be calculated and participants will be categorized into inactive, moderately active, and very active based on MET values.
|
Baseline, 12 weeks, 24 weeks
|
|
Grip strength
時間枠：Baseline, 12 weeks, 24 weeks
|
Handgrip strength will be assessed using a JAMAR dynamometer (Sammons Preston, USA) following the standardized protocol.
Three maximal isometric contractions will be performed with 1-minute rest intervals, the mean of the three trials in kilograms will be used for analysis.
|
Baseline, 12 weeks, 24 weeks
|
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Clinical measures (fasting glucose)
時間枠：Baseline, 12 weeks, 24 weeks
|
Fasting glucose will be recorded from the medical records and will be presented in mmol/L.
|
Baseline, 12 weeks, 24 weeks
|
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Clinical parameters (lipid profile)
時間枠：Baseline, 12 weeks, 24 weeks
|
Total Cholesterol, LDL (Low-Density Lipoprotein) Cholesterol, HDL (High-Density Lipoprotein) Cholesterol, Triglycerides will be recorded from the medical records and presented in mmol/L.
|
Baseline, 12 weeks, 24 weeks
|
|
Muscle thickness
時間枠：Baseline, 12 weeks, 24 weeks
|
Muscle thickness of the biceps femoris, triceps brachii, and biceps brachia will be assessed using a portable ultrasound and will be presented in millimeters (mm).
|
Baseline, 12 weeks, 24 weeks
|
|
Muscle echo intensity
時間枠：Baseline, 12 weeks, 24 weeks
|
Echo intensity will be assessed via a portable muscle ultrasonography using grayscale analysis (0-255 scale) within a standardized region of interest using ImageJ software (National Institutes of Health, USA), with higher values indicating greater intramuscular fat and fibrous tissue infiltration and thus poorer muscle quality.
Assessments will include biceps femoris, biceps brachii, and triceps brachii.
|
Baseline, 12 weeks, 24 weeks
|
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ここでは、この調査に関係する人々や組織を見つけることができます。
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研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (推定)
2026年11月1日
一次修了 (推定)
2027年11月30日
研究の完了 (推定)
2028年1月1日
試験登録日
最初に提出
2026年4月28日
QC基準を満たした最初の提出物
2026年5月21日
最初の投稿 (実際)
2026年5月27日
学習記録の更新
投稿された最後の更新 (実際)
2026年6月4日
QC基準を満たした最後の更新が送信されました
2026年6月3日
最終確認日
2026年4月1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
- Özgül Öztürk
- Grant proposal submitted (その他の識別子：Acıbadem University)
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?
いいえ
IPD プランの説明
Individual participant data (IPD) will not be shared.
The study data contains personal health information.
Also, data sharing may also be limited by institutional policies and data protection legislation.
Findings will be reported in aggregate form.
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
いいえ
米国FDA規制機器製品の研究
いいえ
米国で製造され、米国から輸出された製品。
いいえ
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