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
3 de junio de 2026 actualizado por: 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.
Descripción general del estudio
Estado
Aún no reclutando
Condiciones
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Intervencionista
Inscripción (Estimado)
108
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
- Nombre: Özgül Öztürk, Associate Professor
- Número de teléfono: 902165004185
- Correo electrónico: ozgul.ozturk@acibadem.edu.tr
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
No
Descripción
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.
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: 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
|
|
Comparador activo: Tirzepatide Alone
Standard tirzepatide treatment with usual care and general lifestyle recommendations.
|
Lifestyle recommendations including physical activity and nutritional advice
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Change in muscle thickness
Periodo de tiempo: 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
Periodo de tiempo: 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
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Muscle strength (handheld dynamometer)
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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
|
|
Clinical parameters (blood pressure)
Periodo de tiempo: Baseline, 12 weeks, 24 weeks
|
Blood pressure will be measured using a sphygmomanometer at each assessment point.
|
Baseline, 12 weeks, 24 weeks
|
|
Height
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
|
|
Clinical measures (fasting glucose)
Periodo de tiempo: 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
|
|
Clinical parameters (lipid profile)
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Estimado)
1 de noviembre de 2026
Finalización primaria (Estimado)
30 de noviembre de 2027
Finalización del estudio (Estimado)
1 de enero de 2028
Fechas de registro del estudio
Enviado por primera vez
28 de abril de 2026
Primero enviado que cumplió con los criterios de control de calidad
21 de mayo de 2026
Publicado por primera vez (Actual)
27 de mayo de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
4 de junio de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
3 de junio de 2026
Última verificación
1 de abril de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Manifestaciones neurológicas
- Enfermedades del Sistema Nervioso
- Manifestaciones Neuromusculares
- Trastornos Nutricionales
- Condiciones Patológicas, Anatómicas
- Sobrenutrición
- Peso corporal
- Atrofia Muscular
- Atrofia
- Condiciones Patológicas, Signos y Síntomas
- Comportamiento
- Enfermedades Nutricionales y Metabólicas
- Signos y síntomas
- Exceso de peso
- Obesidad
- Sarcopenia
- Actividad del motor
- Actividad motora
- Movimiento
- Fenómenos fisiológicos musculoesqueléticos
- Fenómenos fisiológicos musculoesqueléticos y neuronales
- Terapéutica
- Modalidades de fisioterapia
- Atención al paciente
- Terapia de ejercicio
- Rehabilitación
- Cuidado por los convalecientes
- Continuidad de la atención al paciente
- Acondicionamiento físico, humano
- Ejercicio
- Entrenamiento de resistencia
Otros números de identificación del estudio
- Özgül Öztürk
- Grant proposal submitted (Otro identificador: Acıbadem University)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
Descripción del plan IPD
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.
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
producto fabricado y exportado desde los EE. UU.
No
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .