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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 junho de 2026 atualizado 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.

Visão geral do estudo

Status

Ainda não está recrutando

Condições

Intervenção / Tratamento

Descrição detalhada

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 estudo

Intervencional

Inscrição (Estimado)

108

Estágio

  • Não aplicável

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Contato de estudo

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

  • Adulto
  • Adulto mais velho

Aceita Voluntários Saudáveis

Não

Descrição

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.

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Tratamento
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Solteiro

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
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..
Outro: Resistance exercise
A 24-week home-based resistance exercises using elastic band and bodyweight
Outro: Lifestyle recommendations
Lifestyle recommendations including physical activity and nutritional advice
Comparador Ativo: Tirzepatide Alone
Standard tirzepatide treatment with usual care and general lifestyle recommendations.
Outro: Lifestyle recommendations
Lifestyle recommendations including physical activity and nutritional advice

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Change in muscle thickness
Prazo: 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
Prazo: 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 resultados secundários

Medida de resultado
Descrição da medida
Prazo
Muscle strength (handheld dynamometer)
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: Baseline, 12 weeks, 24 weeks
Blood pressure will be measured using a sphygmomanometer at each assessment point.
Baseline, 12 weeks, 24 weeks
Height
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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)
Prazo: 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)
Prazo: 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
Prazo: 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
Prazo: 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

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Acibadem University

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Estimado)

1 de novembro de 2026

Conclusão Primária (Estimado)

30 de novembro de 2027

Conclusão do estudo (Estimado)

1 de janeiro de 2028

Datas de inscrição no estudo

Enviado pela primeira vez

28 de abril de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

21 de maio de 2026

Primeira postagem (Real)

27 de maio de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

4 de junho de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

3 de junho de 2026

Última verificação

1 de abril de 2026

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • Özgül Öztürk
  • Grant proposal submitted (Outro identificador: Acıbadem University)

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

NÃO

Descrição do plano 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.

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

produto fabricado e exportado dos EUA

Não

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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