[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100604616":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":32,"locations":38,"responsibleParty":68,"collaborators":31,"id":72,"slug":73,"hasResults":74,"nctId":75,"briefTitle":76,"officialTitle":77,"acronym":78,"eligibilityCriteria":79,"healthyVolunteers":74,"sex":80,"minAge":81,"maxAge":82,"enrollmentInfo":83,"targetDuration":31,"studyType":86,"phases":87,"briefSummary":89,"conditions":90,"keywords":93,"overallStatus":100,"whyStopped":31,"lastUpdateSubmitDate":101,"lastUpdatePostDateStruct":102,"startDateStruct":105,"completionDateStruct":107,"leadSponsor":109,"locationsCount":110},{"fullName":5,"class":6},"Hasanuddin University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Control Cookies (without Gynura procumbens)","PLACEBO_COMPARATOR","Participants receive 4 cookies per day for 12 weeks. The cookies are identical in packaging, size, weight, and flavor but do not contain Gynura procumbens.",[13],"Dietary Supplement: Control Cookies (without Gynura procumbens)",{"label":15,"type":16,"description":17,"interventionNames":18},"GlucoBites (with Gynura procumbens)","EXPERIMENTAL","Participants receive 4 cookies per day for 12 weeks. The cookies contain standardized Gynura procumbens extract.",[19],"Dietary Supplement: GlucoBites (with Gynura procumbens)",[21,26],{"type":22,"name":15,"description":17,"armGroupLabels":23,"otherNames":24},"DIETARY_SUPPLEMENT",[15],[25],"Functional Cookies with Gynura procumbens",{"type":22,"name":9,"description":27,"armGroupLabels":28,"otherNames":29},"Participants consume 4 cookies per day for 12 weeks. The cookies are identical in packaging, size, weight, and flavor to the GlucoBites cookies but do not contain Gynura procumbens.",[9],[30],"Placebo cookies",null,[33],{"name":34,"role":35,"phone":36,"phoneExt":31,"email":37},"Andina Setyawati, Dr","CONTACT","+628121521639","andina@unhas.ac.id",[39],{"facility":40,"status":31,"city":41,"state":42,"zip":43,"country":44,"countryCode":45,"cosmosGeoPoint":46,"geoPoint":51,"contacts":52},"Public Health Centre of Campagaloe","Bantaeng","South Sulawesi","92411","Indonesia","ID",{"type":47,"coordinates":48},"Point",[49,50],119.9509,-5.5475,{"lat":50,"lon":49},[53,57,61,63,66],{"name":54,"role":35,"phone":55,"phoneExt":31,"email":56},"Baucaya Baucaya, BSN","+6282393444557","baucaya75@gmail.com",{"name":58,"role":35,"phone":59,"phoneExt":31,"email":60},"Syamsul Kamar, BSN","+62 82394971423","syamsulkamar81@gmail.com",{"name":34,"role":62,"phone":31,"phoneExt":31,"email":31},"PRINCIPAL_INVESTIGATOR",{"name":64,"role":65,"phone":31,"phoneExt":31,"email":31},"Nuurhidayat Jafar, Dr","SUB_INVESTIGATOR",{"name":67,"role":65,"phone":31,"phoneExt":31,"email":31},"WHIKA FEBRIA DEWATISARI, Dr",{"type":69,"investigatorFullName":70,"investigatorTitle":71,"investigatorAffiliation":5,"oldNameTitle":31,"oldOrganization":31},"SPONSOR_INVESTIGATOR","Andina Setyawati","Principal Investigator","100604616","glucobites-cookies-gynura-procumbens-for-glycemic-control-and-prevention-of-diabetic-foot-ulcer-risk-in-type-2-diabetes-100604616",false,"NCT07151833","GlucoBites Cookies (Gynura Procumbens) for Glycemic Control and Prevention of Diabetic Foot Ulcer Risk in Type 2 Diabetes","Efficacy of GlucoBites Functional Cookies Containing Gynura Procumbens on Glycemic Control, Insulin Resistance, and Prevention of Diabetic Foot Ulcer Risk in Patients With Type 2 Diabetes Mellitus: A Randomized Controlled Trial","GlucoBites","Inclusion Criteria:\n\n* Adults aged 20-70 years.\n* Diagnosed with type 2 diabetes mellitus (T2DM) based on ADA criteria.\n* HbA1c ≥ 7%.\n* At risk of diabetic foot ulcer (ABI \\\u003C 0.9 or early neuropathy signs).\n* Willing to consume study cookies and comply with study protocol.\n* Provided written informed consent.\n\nExclusion Criteria:\n\n* Current use of herbal supplements or functional foods containing Gynura procumbens.\n* Presence of active diabetic foot ulcer or severe infection.\n* Severe cardiovascular, renal (eGFR \\\u003C 30 mL\u002Fmin\u002F1.73 m²), or hepatic impairment.\n* Pregnancy or breastfeeding.\n* Known allergy to ingredients in study cookies.\n* Participation in another clinical trial within the last 3 months.","ALL","20 Years","70 Years",{"count":84,"type":85},126,"ESTIMATED","INTERVENTIONAL",[88],"NA","The goal of this randomized controlled trial is to learn if GlucoBites functional cookies containing Gynura procumbens can help improve blood sugar control and lower the risk of diabetic foot ulcers in adults with type 2 diabetes.\n\nThe main questions are:\n\n* Do GlucoBites cookies lower fasting blood glucose and HbA1c?\n* Do GlucoBites cookies improve insulin resistance and vascular health?\n* Can GlucoBites reduce early signs that may lead to diabetic foot ulcers?\n\nResearchers will compare:\n\n* Intervention group: participants will eat 4 GlucoBites cookies every day for 12 weeks.\n* Control group: participants will continue standard diabetes care without GlucoBites.\n\nParticipants will:\n\n* Visit the community health center for blood tests and foot health checks.\n* Be monitored for blood sugar, insulin resistance, lipid profile, and vascular function.\n* Be assessed for early risk of diabetic foot ulcer development.\n\nThis study will help determine if a functional food innovation can support diabetes care and prevent complications.",[91,92],"Type 2 Diabetes Mellitus","Diabetic Neuropathy",[94,95,96,97,98,99],"Diabetes Mellitus Type 2","Functional Food","Gynura procumbens","Glycemic Control","Insulin Resistance","Diabetic Foot Ulcer Prevention","NOT_YET_RECRUITING","2025-09-02",{"date":103,"type":104},"2025-09-03","ACTUAL",{"date":106,"type":85},"2025-09-20",{"date":108,"type":85},"2026-01-20",{"name":70,"class":6},1]