ObesityNCT07609160
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 study testing Resistance exercise and Lifestyle recommendations in people with Obesity and Sarcopenia, run by Acibadem University.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Obesity, Sarcopenia, Overweight (Without Type 2 Diabetes) With Weight-related Comorbidities
- What is being tested?
- Resistance exercise and Lifestyle recommendations
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2026to 1 Jan 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
Read the detailed description
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.
- Conditions
- Obesity, Sarcopenia, Overweight (Without Type 2 Diabetes) With Weight-related Comorbidities
- Being tested
- Resistance exercise, Lifestyle recommendations
- Keywords
- exercise, physical activity, muscle, physical function
- Medical subject headings
- Obesity, Sarcopenia, Overweight, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Resistance exerciseOther
A 24-week home-based resistance exercises using elastic band and bodyweight
Lifestyle recommendationsOther
Lifestyle recommendations including physical activity and nutritional advice
| Study group | Role | What they receive |
|---|---|---|
| Resistance Exercise + Tirzepatide | Experimental | 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.. Receives: Other: Resistance exercise; Other: Lifestyle recommendations |
| Tirzepatide Alone | Active comparator | Standard tirzepatide treatment with usual care and general lifestyle recommendations. Receives: Other: Lifestyle recommendations |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in muscle thickness
Muscle thickness of the thigh (quadriceps femoris) will be assessed using a portable ultrasound and will be presented in millimeters (mm).
Measured: Baseline, 12 weeks, 24 weeks
Muscle echo intensity
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.
Measured: Baseline, 12 weeks, 24 weeks
Secondary outcomes (18)
Muscle strength (handheld dynamometer)
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.
Measured: Baseline, 12 weeks, 24 weeks
Body weight
Body weight will be assessed using bioelectrical impedance analysis and presented in kilograms (kg).
Measured: Baseline, 12 weeks, 24 weeks
Six-minute walk test
Functional capacity will be assessed using the 6-minute walk test according to standardized procedures and the total distance will be recorded in meters.
Measured: Baseline, 12 weeks, 24 weeks
Physical activity
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.
Measured: Baseline, 12 weeks, 24 weeks
Nutritional status (3-day food record)
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.
Measured: Baseline, 12 weeks, 24 weeks
Quality of life (Short Form-36)
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.
Measured: Baseline, 12 weeks, 24 weeks
Clinical parameters (blood pressure)
Blood pressure will be measured using a sphygmomanometer at each assessment point.
Measured: Baseline, 12 weeks, 24 weeks
Height
Height of the participants will be assessed using a stadiometer and presented in meters.
Measured: Baseline, 12 weeks, 24 weeks
Body mass index
Body mass index will be calculated using height and weight (kg/m^2)
Measured: Baseline, 12 weeks, 24 weeks
Body fat percentage
Body fat percentage will be assessed using bioelectrical impedance analysis and presented in percentage (%).
Measured: Baseline, 12 weeks, 24 weeks
Fat free mass
Fat-free mass will be assessed using bioelectrical impedance analysis and presented in kilograms.
Measured: Baseline, 12 weeks, 24 weeks
Chair stand test
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).
Measured: Baseline, 12 weeks, 24 weeks
Self-reported physical activity
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.
Measured: Baseline, 12 weeks, 24 weeks
Grip strength
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.
Measured: Baseline, 12 weeks, 24 weeks
Clinical measures (fasting glucose)
Fasting glucose will be recorded from the medical records and will be presented in mmol/L.
Measured: Baseline, 12 weeks, 24 weeks
Clinical parameters (lipid profile)
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.
Measured: Baseline, 12 weeks, 24 weeks
Muscle thickness
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).
Measured: Baseline, 12 weeks, 24 weeks
Muscle echo intensity
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.
Measured: Baseline, 12 weeks, 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2026
- Study start1 Nov 2026 (estimated)
- Primary completion30 Nov 2027 (estimated)
- Study completion1 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Acibadem UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 108 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Acibadem University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Özgül Öztürk, Acibadem University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07609160
- Sponsor's protocol ID
- Özgül Öztürk
- Other IDs
- Grant proposal submitted
- Status last verified
- Apr 2026
- First submitted
- 28 Apr 2026
- Last updated
- 4 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07609160
- Acronym / sponsor ID
- Özgül Öztürk
- Conditions
- Obesity, Sarcopenia, Overweight (Without Type 2 Diabetes) With Weight-related Comorbidities
- Keywords
- exercise, physical activity, muscle, physical function
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 108 participants (estimated)
- Lead sponsor
- Acibadem UniversityUniversity, hospital or other
- Study start
- 1 Nov 2026 (estimated)
- Primary completion
- 30 Nov 2027 (estimated)
- Study completion
- 1 Jan 2028 (estimated)
- First posted
- 27 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Resistance Exercise + Tirzepatide | Experimental | Other: Resistance exercise, Other: Lifestyle recommendations24-week home-based progressive resistance exercise program (3 sessions/week) using elastic bands and bodyweight exercises, combined with tirzepatide treatment and general lifestyle recommendations.. |
| Tirzepatide Alone | Active comparator | Other: Lifestyle recommendationsStandard tirzepatide treatment with usual care and general lifestyle recommendations. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Resistance exerciseA 24-week home-based resistance exercises using elastic band and bodyweight | Other | Resistance Exercise + Tirzepatide |
| Lifestyle recommendationsLifestyle recommendations including physical activity and nutritional advice | Other | Resistance Exercise + Tirzepatide, Tirzepatide Alone |
Primary outcome
Change in muscle thickness
Time frame: 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).
Muscle echo intensity
Time frame: 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.
18 secondary outcomes
Muscle strength (handheld dynamometer)
Time frame: Baseline, 12 weeks, 24 weeks
Body weight
Time frame: Baseline, 12 weeks, 24 weeks
Six-minute walk test
Time frame: Baseline, 12 weeks, 24 weeks
Physical activity
Time frame: Baseline, 12 weeks, 24 weeks
Nutritional status (3-day food record)
Time frame: Baseline, 12 weeks, 24 weeks
Quality of life (Short Form-36)
Time frame: Baseline, 12 weeks, 24 weeks
Clinical parameters (blood pressure)
Time frame: Baseline, 12 weeks, 24 weeks
Height
Time frame: Baseline, 12 weeks, 24 weeks
Body mass index
Time frame: Baseline, 12 weeks, 24 weeks
Body fat percentage
Time frame: Baseline, 12 weeks, 24 weeks
Fat free mass
Time frame: Baseline, 12 weeks, 24 weeks
Chair stand test
Time frame: Baseline, 12 weeks, 24 weeks
Self-reported physical activity
Time frame: Baseline, 12 weeks, 24 weeks
Grip strength
Time frame: Baseline, 12 weeks, 24 weeks
Clinical measures (fasting glucose)
Time frame: Baseline, 12 weeks, 24 weeks
Clinical parameters (lipid profile)
Time frame: Baseline, 12 weeks, 24 weeks
Muscle thickness
Time frame: Baseline, 12 weeks, 24 weeks
Muscle echo intensity
Time frame: Baseline, 12 weeks, 24 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2026.
- Individual participant dataSharing planned: No. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing Resistance exercise and Lifestyle recommendations in people with Obesity and Sarcopenia, run by Acibadem University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 4 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Özgül Öztürk, Associate Professor (902165004185, ozgul.ozturk@acibadem.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in muscle thickness (time frame: Baseline, 12 weeks, 24 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2026.