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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. juni 2026 oppdatert av: 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.

Studieoversikt

Status

Har ikke rekruttert ennå

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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.

Studietype

Intervensjonell

Registrering (Antatt)

108

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

Beskrivelse

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.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Enkelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 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..
Annen: Resistance exercise
A 24-week home-based resistance exercises using elastic band and bodyweight
Annen: Lifestyle recommendations
Lifestyle recommendations including physical activity and nutritional advice
Aktiv komparator: Tirzepatide Alone
Standard tirzepatide treatment with usual care and general lifestyle recommendations.
Annen: Lifestyle recommendations
Lifestyle recommendations including physical activity and nutritional advice

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Change in muscle thickness
Tidsramme: 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
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Muscle strength (handheld dynamometer)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: Baseline, 12 weeks, 24 weeks
Blood pressure will be measured using a sphygmomanometer at each assessment point.
Baseline, 12 weeks, 24 weeks
Height
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Acibadem University

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

1. november 2026

Primær fullføring (Antatt)

30. november 2027

Studiet fullført (Antatt)

1. januar 2028

Datoer for studieregistrering

Først innsendt

28. april 2026

Først innsendt som oppfylte QC-kriteriene

21. mai 2026

Først lagt ut (Faktiske)

27. mai 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

4. juni 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

3. juni 2026

Sist bekreftet

1. april 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • Özgül Öztürk
  • Grant proposal submitted (Annen identifikator: Acıbadem University)

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

IPD-planbeskrivelse

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.

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

produkt produsert i og eksportert fra USA

Nei

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