[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100584161":3},{"organization":4,"armGroups":7,"interventions":28,"overallOfficials":27,"centralContacts":37,"locations":48,"responsibleParty":64,"collaborators":68,"id":71,"slug":72,"hasResults":73,"nctId":74,"briefTitle":75,"officialTitle":76,"acronym":77,"eligibilityCriteria":78,"healthyVolunteers":73,"sex":79,"minAge":80,"maxAge":27,"enrollmentInfo":81,"targetDuration":27,"studyType":84,"phases":85,"briefSummary":87,"conditions":88,"keywords":90,"overallStatus":50,"whyStopped":27,"lastUpdateSubmitDate":92,"lastUpdatePostDateStruct":93,"startDateStruct":96,"completionDateStruct":98,"leadSponsor":100,"locationsCount":101},{"fullName":5,"class":6},"Dasman Diabetes Institute","OTHER",[8,14,19,23],{"label":9,"type":10,"description":11,"interventionNames":12},"Resistance exercise","EXPERIMENTAL","Participants assigned to the resistance exercise group will be asked to perform exercises 3 times a week for the intervention period. The first 3 sessions of the exercise will be performed under the supervision of a qualified exercise specialist to ensure that the participants are happy with the exercises and are performing them appropriately. These will also be group sessions to encourage participants to build social connections to support them during the intervention. A similar group social session will take place at week 4 and then every 4 weeks of the study to overcome any issues with the exercises and to ensure progression to an appropriate intensity.",[13],"Behavioral: Resistance exercise",{"label":15,"type":10,"description":16,"interventionNames":17},"Protein Intake","The aim of this arm of the intervention is to ensure a protein intake of 1.6g\u002Fkg\u002Fday, as this was the intake level identified as the level after which no further effect was found on muscle mass in the meta-regression from (Morton et al., 2018). For the initial 2 weeks of the study, investigators will ask participants to consume 2 protein drinks, containing 25g protein (3g leucine), per day - one in the morning and one in the evening. At this stage, investigators won't know the magnitude of reduction of protein intake following initiation of semaglutide\u002Ftirzepatide treatment. After 2 weeks, when the first assessment of dietary intake after beginning semaglutide\u002Ftirzepatide treatment occurs, the additional protein will be based on the amount required to ensure 1.6g\u002Fkg\u002Fday with an aim to spread protein evenly across the day and aim for at least 25g protein (3g leucine) per meal or snack.",[18],"Dietary Supplement: Protein Intake",{"label":20,"type":10,"description":21,"interventionNames":22},"Resistance exercise + protein intake","Participants in this arm will follow the above resistance exercise and protein intake interventions.",[13,18],{"label":24,"type":25,"description":26,"interventionNames":27},"Control","NO_INTERVENTION","Participants assigned to the control group will be asked to maintain their usual exercise habits",null,[29,32],{"type":30,"name":9,"description":11,"armGroupLabels":31,"otherNames":27},"BEHAVIORAL",[9,20],{"type":33,"name":15,"description":16,"armGroupLabels":34,"otherNames":35},"DIETARY_SUPPLEMENT",[15,20],[36],"leucine",[38,44],{"name":39,"role":40,"phone":41,"phoneExt":42,"email":43},"Dr Ebaa Al Ozairi","CONTACT","+965 22242999","3111","ebaa.alozairi@dasmaninstitute.org",{"name":45,"role":40,"phone":46,"phoneExt":27,"email":47},"Prof Stuart Gray","0141 3302569","Stuart.Gray@glasgow.ac.uk",[49],{"facility":5,"status":50,"city":51,"state":27,"zip":27,"country":52,"countryCode":53,"cosmosGeoPoint":54,"geoPoint":59,"contacts":60},"RECRUITING","Kuwait City","Kuwait","KW",{"type":55,"coordinates":56},"Point",[57,58],47.97429,29.367,{"lat":58,"lon":57},[61],{"name":62,"role":40,"phone":63,"phoneExt":27,"email":43},"Dr. Ebaa Al Ozairi, MD","22242999",{"type":65,"investigatorFullName":66,"investigatorTitle":67,"investigatorAffiliation":5,"oldNameTitle":27,"oldOrganization":27},"PRINCIPAL_INVESTIGATOR","Dr. Ebaa Al Ozairi","Chief Medical Officer (CMO)",[69],{"name":70,"class":6},"University of Glasgow","100584161","lean-mass-preservation-with-resistance-exercise-and-protein-during-semaglutidetirzepatide-therapy-100584161",false,"NCT06885736","LEAN Mass Preservation With Resistance Exercise and Protein During Semaglutide\u002FTirzepatide Therapy","LEAN Mass Preservation With Resistance Exercise and Protein During Semaglutide and Tirzepatide Therapy (LEAN-PREP Study)","LEAN-PREP","Inclusion Criteria:\n\n* Age \\>\u002F= 18 years\n* BMI \\>\u002F= 27 kg\u002Fm2\n\nExclusion Criteria:\n\n* Currently or in the past 6 months participating in any vigorous aerobic activity (\\>1h per week) or any resistance exercise.\n* BP of 160\u002F100mmHg or higher\n* Any known medical condition that prevents participants from exercising safely\n* A personal or family history of medullary thyroid carcinoma\n* Multiple Endocrine Neoplasia syndrome type 2 (MEN 2)\n* History of chronic or acute pancreatitis\n* History of proliferative diabetic retinopathy or diabetic maculopathy\n* History of ketoacidosis or hyperosmolar state\u002Fcoma\n* History of severe hypoglycaemia and\u002For hypoglycaemia unawareness within last 6 months\n* Clinically significant gastric emptying abnormality or have undergone or plan to undergo gastric bypass or restrictive bariatric surgery or chronically taking drugs that directly affect GI motility\n* Any of the following CV conditions in last 2 months: acute MI, stroke or hospitilisation due to CHF\n* History of NYHA IV CHF\n* Acute or chronic hepatitits, signs and symptoms of any liver disease other than NAFLD, ALT \\> 3 times the upper limit of normal\n* eGFR \\\u003C45mL\u002Fmin\u002F1.73m2\n* Significant uncontrolled endocrine abnormaility in the opinion of clinical investigator\n* Evidence of active autoimmune abnormality that is likely to requite systemic glucocorticoid treatment in the next 12 months\n* Had or waiting for an organ transplant\n* History of an active or untreated malignancy or in remission from a clinically significant malignancy for less than 5 years\n* Any other aspect of history or condition that may limit the ability of the patient to complete the study\n* Having been treated with prescription drugs that promote weight loss in the last 3 months\n* Receiving chronic systemic glucocorticoid therapy within last month","ALL","18 Years",{"count":82,"type":83},232,"ESTIMATED","INTERVENTIONAL",[86],"NA","The aim of the current study is to determine whether resistance exercise and\u002For protein intake can preserve lean mass and improve physical function in patients with obesity initiating semaglutide\u002Ftirzepatide therapy. To achieve this aim the study will have the following objectives.\n\nIn people with obesity initiating semaglutide\u002Ftirzepatide therapy\n\n1. Form a PPI group to refine the study protocol and establish study materials,\n2. Quantify the effects of a pragmatic resistance exercise intervention and\u002For increasing protein intake on lean mass and physical function during semaglutide\u002Ftirzepatide induced weight loss,\n3. Establish whether the resistance exercise intervention and\u002For increasing protein intake has concomitant benefits on glycaemic control, lipids, liver function, quality of life, physical activity and sleep during semaglutide\u002Ftirzepatide induced weight loss.\n\nThe participants will:\n\nBegin their weight loss medication, starting at a low dose and then increasing the dose to maximize weight loss. They will be randomly assigned by a computer to ONE of the following groups and will be followed up to 6-months:\n\n* Control group\n* Protein intake group\n* Muscle strengthening exercise group\n* Muscle strengthening exercise AND protein intake group.",[89],"Obesity",[91],"Obesity, research","2026-04-19",{"date":94,"type":95},"2026-04-21","ACTUAL",{"date":97,"type":95},"2025-08-07",{"date":99,"type":83},"2029-12-31",{"name":5,"class":6},1]