{
  "abstract": "Introduction Obesity is a global public health issue, with its effects a particular issue in Kuwait. Advances in pharmaceutical treatment (eg, glucagon-like peptide-1s) offer an effective solution, with the magnitude of weight lost something to celebrate. However, this level of weight loss also results in dramatic reductions in lean mass, reflecting loss of muscle mass and muscle strength which can predispose people to sarcopenia. This is a particular issue in people with type 2 diabetes in Kuwait, where the prevalence of muscle weakness is extremely high. Solutions to mitigate this loss of muscle mass and strength are needed, with a pragmatic resistance exercise intervention and increasing dietary protein intake having potential. This trial aims to determine whether resistance exercise and/or protein intake can preserve muscle mass and improve physical function in people with obesity initiating semaglutide/tirzepatide therapy.Methods and analysis This single-centre, 6-month, randomised controlled trial at Dasman Diabetes Institute will enrol 232 adults with obesity, randomised (1:1:1:1) to control, resistance exercise, protein supplementation or combined resistance exercise and protein in conjunction with semaglutide or tirzepatide therapy. Resistance exercise will be home-based and involve three sessions per week, progressing from one to three sets targeting major muscle groups. Protein supplementation will target 1.6 g/kg/day via dietary adjustment and protein products. Assessments at baseline and 6 months will include MRI measured quadriceps cross-sectional area (primary outcome), plus measures of secondary outcomes of MRI measured liver fat content and stiffness and intramuscular fat, body composition (dual energy X-ray absorptiometry), strength, physical function, dietary assessment, physical activity levels, sleep patterns, quality of life, glycaemic control and metabolic biomarkers.Ethics and dissemination The study has received ethical approval from the Dasman Diabetes Institute Ethical Review Committee (HR-RA-2025-01, 19 February 2025) and is registered at ClinicalTrials.gov ( NCT06885736, 26 June 2025). Written informed consent will be obtained from all participants, with no financial compensation provided. Data will be reported in accordance with Consolidated Standards of Reporting Trials (CONSORT) guidelines, ensuring participant anonymity. Findings will be disseminated through peer-reviewed publications and presentations at national and international conferences.Trial registration number NCT06885736.",
  "authors": [
    {
      "affiliations": [
        "Clinical Care Research and Trials, Dasman Diabetes Institute, Kuwait City, Kuwait"
      ],
      "name": "Ameenah A Alawadhi"
    },
    {
      "affiliations": [
        "Education and Training Unit, Dasman Diabetes Institute, Kuwait City, Kuwait"
      ],
      "name": "Dherar Alroudhan"
    },
    {
      "affiliations": [
        "Clinical Care Research and Trials, Dasman Diabetes Institute, Kuwait City, Kuwait"
      ],
      "name": "Dalal J Alsaeed"
    },
    {
      "affiliations": [
        "Clinical Care Research and Trials, Dasman Diabetes Institute, Kuwait City, Kuwait"
      ],
      "name": "Bashayer W Almarshad"
    },
    {
      "affiliations": [
        "Clinical Care Research and Trials, Dasman Diabetes Institute, Kuwait City, Kuwait"
      ],
      "name": "Dalal H Alshehabi"
    },
    {
      "affiliations": [
        "Nutrition Unit, Dasman Diabetes Institute, Kuwait City, Kuwait"
      ],
      "name": "Badreya A Allahou"
    },
    {
      "affiliations": [
        "Medical Division, Dasman Diabetes Institute, Kuwait City, Kuwait"
      ],
      "name": "Anant Mashankar"
    },
    {
      "affiliations": [
        "Medical Division, Dasman Diabetes Institute, Kuwait City, Kuwait"
      ],
      "name": "Ebaa Al Ozairi"
    },
    {
      "affiliations": [
        "Institute of Cardiovascular and Medical Sciences, BHF Glasgow Cardiovascular Research Centre, University of Glasgow, Glasgow, UK"
      ],
      "name": "Stuart Gray"
    }
  ],
  "title": "LEAN mass Preservation with Resistance Exercise and Protein during semaglutide and tirzepatide therapy (LEAN-PREP study): a protocol for a randomised controlled trial",
  "uid": "f4c93e5f-399a-5bc7-9d25-258c61191d0b"
}