Deze pagina is automatisch vertaald en de nauwkeurigheid van de vertaling kan niet worden gegarandeerd. Raadpleeg de Engelse versie voor een brontekst.

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 bijgewerkt door: 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.

Studie Overzicht

Toestand

Nog niet aan het werven

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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

Ingrijpend

Inschrijving (Geschat)

108

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Nee

Beschrijving

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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Enkel

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: 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..
Ander: Resistance exercise
A 24-week home-based resistance exercises using elastic band and bodyweight
Ander: Lifestyle recommendations
Lifestyle recommendations including physical activity and nutritional advice
Actieve vergelijker: Tirzepatide Alone
Standard tirzepatide treatment with usual care and general lifestyle recommendations.
Ander: Lifestyle recommendations
Lifestyle recommendations including physical activity and nutritional advice

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Change in muscle thickness
Tijdsspanne: 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
Tijdsspanne: 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

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Muscle strength (handheld dynamometer)
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: Baseline, 12 weeks, 24 weeks
Blood pressure will be measured using a sphygmomanometer at each assessment point.
Baseline, 12 weeks, 24 weeks
Height
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Acibadem University

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Geschat)

1 november 2026

Primaire voltooiing (Geschat)

30 november 2027

Studie voltooiing (Geschat)

1 januari 2028

Studieregistratiedata

Eerst ingediend

28 april 2026

Eerst ingediend dat voldeed aan de QC-criteria

21 mei 2026

Eerst geplaatst (Werkelijk)

27 mei 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

4 juni 2026

Laatste update ingediend die voldeed aan QC-criteria

3 juni 2026

Laatst geverifieerd

1 april 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • Özgül Öztürk
  • Grant proposal submitted (Andere identificatie: Acıbadem University)

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Beschrijving IPD-plan

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.

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

product vervaardigd in en geëxporteerd uit de V.S.

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

Abonneren