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 opdateret af: 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.
Studieoversigt
Status
Ikke rekrutterer endnu
Intervention / Behandling
Detaljeret 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.
Undersøgelsestype
Interventionel
Tilmelding (Anslået)
108
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: Özgül Öztürk, Associate Professor
- Telefonnummer: 902165004185
- E-mail: ozgul.ozturk@acibadem.edu.tr
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Ingen
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
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: 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
|
|
Aktiv komparator: Tirzepatide Alone
Standard tirzepatide treatment with usual care and general lifestyle recommendations.
|
Lifestyle recommendations including physical activity and nutritional advice
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
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 |
Foranstaltningsbeskrivelse |
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
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Anslået)
1. november 2026
Primær færdiggørelse (Anslået)
30. november 2027
Studieafslutning (Anslået)
1. januar 2028
Datoer for studieregistrering
Først indsendt
28. april 2026
Først indsendt, der opfyldte QC-kriterier
21. maj 2026
Først opslået (Faktiske)
27. maj 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
4. juni 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
3. juni 2026
Sidst verificeret
1. april 2026
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
- Neurologiske manifestationer
- Sygdomme i nervesystemet
- Neuromuskulære manifestationer
- Ernæringsforstyrrelser
- Patologiske Tilstande, Anatomiske
- Overernæring
- Kropsvægt
- Muskelatrofi
- Atrofi
- Patologiske tilstande, tegn og symptomer
- Opførsel
- Ernæringsmæssige og metaboliske sygdomme
- Tegn og symptomer
- Overvægtig
- Fedme
- Sarkopeni
- Motorisk aktivitet
- Motorisk aktivitet
- Bevægelse
- Muskuloskeletale fysiologiske fænomener
- Muskuloskeletale og neurale fysiologiske fænomener
- Terapeutik
- Fysioterapimodaliteter
- Patientpleje
- Træningsterapi
- Rehabilitering
- Efterpleje
- Kontinuitet i patientpleje
- Fysisk konditionering, menneske
- Øvelse
- Modstandstræning
Andre undersøgelses-id-numre
- Özgül Öztürk
- Grant proposal submitted (Anden identifikator: Acıbadem University)
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
INGEN
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.
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