[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100510399":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":23,"centralContacts":24,"locations":23,"responsibleParty":34,"collaborators":23,"id":36,"slug":37,"hasResults":38,"nctId":39,"briefTitle":40,"officialTitle":41,"acronym":23,"eligibilityCriteria":42,"healthyVolunteers":43,"sex":44,"minAge":45,"maxAge":46,"enrollmentInfo":47,"targetDuration":23,"studyType":50,"phases":51,"briefSummary":53,"conditions":54,"keywords":23,"overallStatus":56,"whyStopped":23,"lastUpdateSubmitDate":57,"lastUpdatePostDateStruct":58,"startDateStruct":61,"completionDateStruct":63,"leadSponsor":65,"locationsCount":23},{"fullName":5,"class":6},"Diabetes Foundation, India","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"High Protein Diet","EXPERIMENTAL","High protein diet (carbohydrates 45%, protein 29%, and fat 26%) over 8-week periods. All assessments as done on day 1 will be repeated on day 60.",[13],"Other: Intervention",{"label":15,"type":6,"description":16,"interventionNames":17},"Control Group","Equicaloric normal diet (carbohydrates 60%, protein 15%, and fat 25%)",[13],[19],{"type":6,"name":20,"description":21,"armGroupLabels":22,"otherNames":23},"Intervention","high protein diet (carbohydrates 45%, protein 29%, and fat 26%) over 8-week periods.",[15,9],null,[25,30],{"name":26,"role":27,"phone":28,"phoneExt":23,"email":29},"Anoop Misra, MD","CONTACT","01149101222","anoopmisra@gmail.com",{"name":31,"role":27,"phone":32,"phoneExt":23,"email":33},"Surya Prakash, PhD+Post Doc","01141759672","suryabhat@gmail.com",{"type":35,"investigatorFullName":23,"investigatorTitle":23,"investigatorAffiliation":23,"oldNameTitle":23,"oldOrganization":23},"SPONSOR","100510399","high-protein-diet-on-transcriptomic-metabolomics-hepatic-and-pancreatic-fat-anatomy-and-physiology-in-asian-indians-with-pre-diabetes-100510399",false,"NCT05925933","High Protein Diet on Transcriptomic, Metabolomics, Hepatic and Pancreatic Fat Anatomy and Physiology in Asian Indians With Pre-diabetes","Effect of High Protein Diet on Transcriptomic Regulations, Plasma Metabolomics, Hepatic and Pancreatic Fat Anatomy and Physiology in Asian Indians With Pre-diabetes","Exclusion Criteria:\n\n* Acute infections and advanced end-organ damage.\n* History of hepatitis or pancreatitis, abnormal liver and renal function tests.\n* Recent (\\\u003C3 months) changes in weight (≥5%) and\u002For weight changing medications.\n* Subjects with metallic implants, pacemaker leads, radioactive seeds or surgical staples in the body.\n\nInclusion Criteria\n\nCases:\n\n* Age 18 to 50 years. Subjects with pre-diabetes on oral glucose tolerance test (OGTT)\n* Fasting blood glucose≥100mg\u002Fdl and \\\u003C126 mg\u002Fdl or 2-h plasma glucose ≥140mg\u002Fdl and \\\u003C200mg\u002Fdl (after ingestion of 75 grams of anhydrous oral glucose) or both.\n\nControls:\n\n* Age 18 to 50 years. Normoglycemia by OGTT\n* Fasting blood glucose \\\u003C100mg\u002Fdl and 2-h plasma glucose \\\u003C140mg\u002Fdl (after ingestion of 75 gram of anhydrous oral glucose).",true,"ALL","18 Years","50 Years",{"count":48,"type":49},60,"ESTIMATED","INTERVENTIONAL",[52],"NA","Diabetes\u002F prediabetes is a substantial problem in India not only because it itself can be associated with morbidities such as coronary artery disease but also because it is a point of importance for the prevention of other diseases. It is not clear if a high protein calorie diet in the Indian population associated with a heightened tendency for prediabetes, metabolic syndrome, atherosclerosis and dysmetabolic state etc. could, besides lifestyle factors, be related to diet, or interaction between the two. The analysis of whole blood transcriptomes and plasma metabolomics profiles may be a potentially useful tool for the assessment of metabolic health status. The proposed study is the first to perform a detailed gene expression profiling with the use of next-generation sequencing technology to assess the differences in molecular mechanisms in the peripheral blood of subjects with prediabetes.",[55],"Pre-diabetes","NOT_YET_RECRUITING","2023-06-22",{"date":59,"type":60},"2023-06-29","ACTUAL",{"date":62,"type":49},"2023-10-01",{"date":64,"type":49},"2026-10-31",{"name":5,"class":6}]