[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100584161":3},{"organization":4,"outcomesModule":7,"designInfo":83,"detailedDescription":40,"studyPopulation":40,"armGroups":93,"interventions":113,"overallOfficials":40,"centralContacts":122,"locations":133,"responsibleParty":149,"collaborators":153,"id":156,"slug":157,"hasResults":158,"nctId":159,"briefTitle":160,"officialTitle":161,"acronym":162,"eligibilityCriteria":163,"healthyVolunteers":158,"sex":164,"minAge":165,"maxAge":40,"enrollmentInfo":166,"targetDuration":40,"studyType":169,"phases":170,"briefSummary":172,"conditions":173,"keywords":175,"overallStatus":135,"whyStopped":40,"lastUpdateSubmitDate":177,"lastUpdatePostDateStruct":178,"startDateStruct":181,"completionDateStruct":183,"leadSponsor":185,"locationsCount":186},{"fullName":5,"class":6},"Dasman Diabetes Institute","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":40},[9],{"measure":10,"description":11,"timeFrame":12},"MRI measured quadriceps cross sectional area (CSA)","At the mid-point of the thigh, investigators will measure the cross-sectional area of the quadriceps muscle and quantify muscle's thickness and size.","From enrollment (at baseline) to the end of treatment at 6 months.",[14,17,20,23,26,29,32,35,38,41,44,47,50,53,55,58,61,64,67,70,74,77,80],{"measure":15,"description":16,"timeFrame":12},"MRI measured intramuscular fat content (total thigh)","investigators will quantify intramuscular fat content",{"measure":18,"description":19,"timeFrame":12},"MRI measured liver fat","investigators will also assess liver fat using 3-D sequence (MR-Touch) magnetic resonance elastography (MRE",{"measure":21,"description":22,"timeFrame":12},"MRI measured liver stiffness","investigators will also assess liver stiffness using an IDEAL scan.",{"measure":24,"description":25,"timeFrame":12},"Body Composition via DEXA scan","fat and fat free mass via Dual Energy X-ray Absorptiometry (DEXA)",{"measure":27,"description":28,"timeFrame":12},"Muscle strength","Grip strength will be measured 3 times in each hand using a Jamar dynamometer.",{"measure":30,"description":31,"timeFrame":12},"Chair rise performance","The number of chair rises completed in 30 seconds measured.",{"measure":33,"description":34,"timeFrame":12},"Gait Speed","Habitual gait speed will be measured during a 4 metre walk test",{"measure":36,"description":37,"timeFrame":12},"Aerobic Fitness","Aerobic fitness will be quantified with the 6 min walk test.",{"measure":39,"description":40,"timeFrame":12},"Whole blood glycated haemoglobin (HbA1c)",null,{"measure":42,"description":43,"timeFrame":12},"Liver function","investigators will measure aspartate amino transferase (AST), alanine transaminase (ALT), alkaline phosphatase (ALP), albumin (ALB), total protein (TP), gamma-glutamyltransferase (GGT) and bilirubin.",{"measure":45,"description":46,"timeFrame":12},"eGFR","investigators will assess kidney function by estimating the glomerular filtration rate (eGFR).",{"measure":48,"description":49,"timeFrame":12},"Blood lipids profile","investigators will assess participants' lipid profiles by measuring the concentrations of high-density lipoprotein cholesterol (HDL-C), low-density lipoprotein cholesterol (LDL-C), very-low-density lipoprotein cholesterol (VLDL-C), triglycerides (TG), and total cholesterol.",{"measure":51,"description":52,"timeFrame":12},"Fibrosis-4 (FIB-4) Index Score","Fibrosis-4 (FIB-4) Index score will be calculated using liver function test parameters, including age, aspartate aminotransferase (AST), alanine aminotransferase (ALT), and platelet count. The FIB-4 index is a continuous score used to estimate the degree of liver fibrosis. There is no fixed minimum or maximum value; however, higher scores indicate more advanced liver fibrosis and therefore a worse outcome.",{"measure":54,"description":40,"timeFrame":12},"hsCRP",{"measure":56,"description":57,"timeFrame":12},"Inflammatory profiles","investigators will assess participants' inflammatory profiles by measuring the circulating levels of interleukin-6 (IL-6), interleukin-10 (IL-10), interleukin-1 receptor antagonist (IL-1Ra), and tumor necrosis factor-alpha (TNF-α).",{"measure":59,"description":60,"timeFrame":12},"Oral glucose tolerance test","An oral glucose tolerance test will be performed with a cannula inserted and a baseline blood sample collected, a 75g glucose load consumed and further samples collected at 15, 30, 60 90 and 120 min. Samples will be analysed for glucose and insulin levels.",{"measure":62,"description":63,"timeFrame":12},"Physical Activity Level","Participants will complete International Physical Activity Questionnaire (IPAQ) which measures physical activity across multiple domains (e.g., work, transport, domestic, and leisure activities). The IPAQ provides a continuous score expressed in Metabolic Equivalent of Task (MET)-minutes per week.\n\nThe total score has no fixed minimum or maximum value; higher scores indicate higher levels of physical activity, and therefore represent a better outcome (greater physical activity).",{"measure":65,"description":66,"timeFrame":12},"Sleep Quality and Disturbances","Sleep quality will be assessed using the Pittsburgh Sleep Quality Index (PSQI), a validated questionnaire that evaluates sleep quality and sleep disturbances over a 1-month period. The PSQI generates a global score ranging from 0 to 21, where higher scores indicate poorer sleep quality (worse outcome).",{"measure":68,"description":69,"timeFrame":12},"Health-Related Quality of Life","Health-related quality of life will be assessed using the EuroQol 5-Dimension 5-Level questionnaire (EQ-5D-5L). This standardized instrument measures health status across five domains: mobility, self-care, usual activities, pain\u002Fdiscomfort, and anxiety\u002Fdepression. Responses are converted into a single utility index score.\n\nThe EQ-5D-5L index score typically ranges from less than 0 (states worse than death) to 1 (full health), where higher scores indicate better health-related quality of life (better outcome).",{"measure":71,"description":72,"timeFrame":73},"Baseline Dietary intake","Baseline dietary intake will be assessed using the EatWellQ8 Food Frequency Questionnaire (FFQ), a validated dietary assessment tool for the Kuwaiti population. The FFQ is used to estimate habitual dietary intake across food groups and nutrients over a defined recall period.\n\nThe questionnaire generates continuous estimates of dietary intake based on reported frequency of consumption of food items and standard portion sizes (grams). There is no fixed minimum or maximum score. Higher values indicate greater consumption of the corresponding food or nutrient, with interpretation dependent on the specific dietary component being analyzed.","Assessed at baseline (enrollment).",{"measure":75,"description":76,"timeFrame":12},"Macronutrient Intake","Baseline carbodhyrate, fat and protein intake (all g\u002Fday) will be quantified by the use of the EPIC food frequency questionnaire and multi-pass 24h recall. Further 24h recalls will be carried out at 0.5,1,3 and 6 months of the follow up period.",{"measure":78,"description":79,"timeFrame":12},"Activities of Daily Living","Activities of daily living will be assessed using the Barthel Index of Activities of Daily Living, a validated scale that measures functional independence in personal care and mobility tasks (e.g., feeding, bathing, grooming, dressing, bowel and bladder control, toileting, transfers, mobility, and stair climbing).\n\nThe Barthel Index generates a total score ranging from 0 to 100, where higher scores indicate greater independence in activities of daily living (better outcome), and lower scores indicate greater dependency (worse outcome).",{"measure":81,"description":82,"timeFrame":12},"Concomitant medication Use","Concomitant medication use will be assessed by systematic documentation of all medications taken by participants throughout the study period, including prescription medications, over-the-counter drugs, and dietary supplements. Data will be collected at each study visit through structured participant interviews and review of medical records.\n\nMedications will be recorded descriptively and categorized by therapeutic class, dose, frequency, and duration of use.",{"allocation":84,"interventionModel":85,"interventionModelDescription":86,"primaryPurpose":87,"observationalModel":40,"timePerspective":40,"maskingInfo":88},"RANDOMIZED","PARALLEL","This will be a 6-month 4 arm (control, resistance exercise, protein intake and resistance exercise + protein intake) randomised controlled trial in people with obesity upon initiation of semaglutide\u002Ftirzepatide therapy.","BASIC_SCIENCE",{"masking":89,"maskingDescription":90,"whoMasked":91},"SINGLE","The researcher and the participant will be blinded to the allocation pattern. It is not possible to blind participants to treatment allocation but people making outcome measurements and performing statistical analysis will be blinded.",[92],"OUTCOMES_ASSESSOR",[94,100,105,109],{"label":95,"type":96,"description":97,"interventionNames":98},"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.",[99],"Behavioral: Resistance exercise",{"label":101,"type":96,"description":102,"interventionNames":103},"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.",[104],"Dietary Supplement: Protein Intake",{"label":106,"type":96,"description":107,"interventionNames":108},"Resistance exercise + protein intake","Participants in this arm will follow the above resistance exercise and protein intake interventions.",[99,104],{"label":110,"type":111,"description":112,"interventionNames":40},"Control","NO_INTERVENTION","Participants assigned to the control group will be asked to maintain their usual exercise habits",[114,117],{"type":115,"name":95,"description":97,"armGroupLabels":116,"otherNames":40},"BEHAVIORAL",[95,106],{"type":118,"name":101,"description":102,"armGroupLabels":119,"otherNames":120},"DIETARY_SUPPLEMENT",[101,106],[121],"leucine",[123,129],{"name":124,"role":125,"phone":126,"phoneExt":127,"email":128},"Dr Ebaa Al Ozairi","CONTACT","+965 22242999","3111","ebaa.alozairi@dasmaninstitute.org",{"name":130,"role":125,"phone":131,"phoneExt":40,"email":132},"Prof Stuart Gray","0141 3302569","Stuart.Gray@glasgow.ac.uk",[134],{"facility":5,"status":135,"city":136,"state":40,"zip":40,"country":137,"countryCode":138,"cosmosGeoPoint":139,"geoPoint":144,"contacts":145},"RECRUITING","Kuwait City","Kuwait","KW",{"type":140,"coordinates":141},"Point",[142,143],47.97429,29.367,{"lat":143,"lon":142},[146],{"name":147,"role":125,"phone":148,"phoneExt":40,"email":128},"Dr. Ebaa Al Ozairi, MD","22242999",{"type":150,"investigatorFullName":151,"investigatorTitle":152,"investigatorAffiliation":5,"oldNameTitle":40,"oldOrganization":40},"PRINCIPAL_INVESTIGATOR","Dr. Ebaa Al Ozairi","Chief Medical Officer (CMO)",[154],{"name":155,"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":167,"type":168},232,"ESTIMATED","INTERVENTIONAL",[171],"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.",[174],"Obesity",[176],"Obesity, research","2026-04-19",{"date":179,"type":180},"2026-04-21","ACTUAL",{"date":182,"type":180},"2025-08-07",{"date":184,"type":168},"2029-12-31",{"name":5,"class":6},1]