[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100643182":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":32,"centralContacts":41,"locations":51,"responsibleParty":68,"collaborators":71,"id":82,"slug":83,"hasResults":84,"nctId":85,"briefTitle":86,"officialTitle":87,"acronym":88,"eligibilityCriteria":89,"healthyVolunteers":84,"sex":90,"minAge":91,"maxAge":92,"enrollmentInfo":93,"targetDuration":31,"studyType":96,"phases":97,"briefSummary":99,"conditions":100,"keywords":103,"overallStatus":54,"whyStopped":31,"lastUpdateSubmitDate":115,"lastUpdatePostDateStruct":116,"startDateStruct":119,"completionDateStruct":121,"leadSponsor":123,"locationsCount":124},{"fullName":5,"class":6},"ENBIOSIS BIOTECHNOLOGIES","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Microbiome-targeted oral food supplement","EXPERIMENTAL","Fixed AI-guided microbiome-targeted oral food supplement administered orally once daily for 24 weeks as one sachet plus one capsule. The formulation is fixed and identical for all participants randomized to the active intervention arm. The proprietary formulation was reviewed as part of the ethics committee submission and is locked before participant enrolment. The artificial intelligence methodology was used before the trial for formulation design only and is not used during the trial for participant-level prediction, dosing, clinical decision-making, or formulation adjustment.",[13],"Dietary Supplement: Microbiome-targeted oral food supplement",{"label":15,"type":16,"description":17,"interventionNames":18},"Matching placebo oral supplement","PLACEBO_COMPARATOR","Matching placebo oral supplement administered orally once daily for 24 weeks as one sachet plus one capsule. The placebo is matched to the active product in appearance, taste, smell, packaging, administration schedule, and storage conditions. The placebo is intended to be microbiome- and glycaemia-neutral and free of active prebiotic, probiotic, synbiotic, postbiotic, glycaemically active, or other bioactive components reasonably expected to affect HbA1c, fasting plasma glucose, body weight, microbiome composition, or inflammatory markers.",[19],"Dietary Supplement: Matching placebo oral supplement",[21,28],{"type":22,"name":9,"description":23,"armGroupLabels":24,"otherNames":25},"DIETARY_SUPPLEMENT","Fixed AI-guided microbiome-targeted oral food supplement administered for 24 weeks. The formulation is fixed and identical for all participants randomized to the active intervention arm. The artificial intelligence methodology was used before the trial for formulation design only and is not used during the trial for participant-level prediction, dosing, clinical decision-making, or formulation adjustment. Participants also receive identical structured lifestyle counselling and continue stable permitted background glucose-lowering therapy as clinically appropriate.",[9],[26,27],"AIM-MET active intervention","AI-guided microbiome-targeted nutritional intervention",{"type":22,"name":15,"description":29,"armGroupLabels":30,"otherNames":31},"Matching placebo oral supplement administered for 24 weeks. The placebo is matched to the active product in appearance, taste, smell, packaging, administration schedule, and storage conditions. The placebo is intended to be microbiome- and glycaemia-neutral and free of active prebiotic, probiotic, synbiotic, postbiotic, glycaemically active, or other bioactive components reasonably expected to affect HbA1c, fasting plasma glucose, body weight, microbiome composition, or inflammatory markers. Participants also receive identical structured lifestyle counselling and continue stable permitted background glucose-lowering therapy as clinically appropriate.",[15],null,[33,37],{"name":34,"affiliation":35,"role":36},"Engin Güney, Prof. Dr.","Aydın Adnan Menderes University Faculty of Medicine Endocrinology Department","STUDY_CHAIR",{"name":38,"affiliation":39,"role":40},"Varol Tunali, Dr.","Enbiosis Biotechnology Limited","PRINCIPAL_INVESTIGATOR",[42,47],{"name":43,"role":44,"phone":45,"phoneExt":31,"email":46},"Varol TUNALI, Dr.","CONTACT","+905556303231","vtunali@enbiosis.com",{"name":48,"role":44,"phone":49,"phoneExt":31,"email":50},"Buğra Yağmur, Mr","+90 505 632 82 82","byagmur@enbiosis.com",[52],{"facility":53,"status":54,"city":55,"state":31,"zip":31,"country":56,"countryCode":31,"cosmosGeoPoint":57,"geoPoint":62,"contacts":63},"Bakırçay University Faculty of Medicine Endocrinology Department","RECRUITING","Izmir","Turkey (Türkiye)",{"type":58,"coordinates":59},"Point",[60,61],27.13838,38.41273,{"lat":61,"lon":60},[64],{"name":65,"role":44,"phone":66,"phoneExt":31,"email":67},"Sedat Güney, Dr.","+90 554 844 92 66","sedat.guney@cbu.edu.tr",{"type":40,"investigatorFullName":69,"investigatorTitle":70,"investigatorAffiliation":5,"oldNameTitle":31,"oldOrganization":31},"Varol TUNALI","Chief Medical Officer (CMO)",[72,75,78,80],{"name":73,"class":74},"Bakırçay University, Faculty of Medicine","UNKNOWN",{"name":76,"class":77},"Aydin Adnan Menderes University","OTHER",{"name":79,"class":77},"Buca Seyfi Demirsoy State Hospital",{"name":81,"class":77},"Izmir University of Economics","100643182","aim-met-ai-guided-microbiome-targeted-nutrition-for-glycemic-improvement-in-type-2-diabetes-100643182",false,"NCT07622628","AIM-MET: AI-Guided Microbiome-Targeted Nutrition for Glycemic Improvement in Type 2 Diabetes","A 24-Week Randomized, Masked, Placebo-Controlled Trial of an AI-Guided Microbiome-Targeted Nutritional Intervention for Glycemic Improvement in Adults With Type 2 Diabetes: The AIM-MET Trial","AIM-MET","Inclusion Criteria:\n\nAdults aged 18 to 65 years.\n\nEstablished diagnosis of type 2 diabetes mellitus documented in the medical record, supported by American Diabetes Association diagnostic criteria on at least one prior occasion.\n\nHbA1c 6.8% to 8.2% at screening, measured by an NGSP-certified central laboratory assay; confirmed on a repeat sample if discordant with prior records or if the screening value is at the upper or lower boundary.\n\nBody mass index 18.5 to 40.0 kg\u002Fm2 at screening.\n\nStable background glucose-lowering therapy for at least 3 months before randomization, restricted to metformin, a DPP-4 inhibitor, and\u002For an SGLT2 inhibitor, either alone or in combination.\n\nDocumented body-weight stability, defined as no more than +\u002F-5% or +\u002F-3 kg, whichever is smaller, self-reported body-weight change during the 3 months before screening.\n\nWilling and able to provide written informed consent.\n\nWilling and able to comply with trial visits, study product use, fasting blood sampling, stool sampling, and the study assessment schedule.\n\nWilling to receive standardized lifestyle counselling during the 24-week blinded period and to maintain stable background diabetes management as clinically directed.\n\nNo systemic antibiotic use within 8 weeks before randomization.\n\nNo probiotic, prebiotic, synbiotic, or postbiotic supplement use within 8 weeks before randomization.\n\nStable hypertension, dyslipidaemia, and stable thyroid replacement therapy are permitted if medication has been initiated and the dose unchanged for at least 3 months before randomization.\n\nExclusion Criteria:\n\nType 1 diabetes, latent autoimmune diabetes of adults, pancreatogenic diabetes, maturity-onset diabetes of the young, gestational diabetes as the current diagnosis, or any non-type-2 form of diabetes.\n\nHbA1c less than 6.8% or greater than 8.2% at screening.\n\nCurrent use of GLP-1 receptor agonists or GLP-1\u002FGIP co-agonists, or use within 12 months before randomization.\n\nCurrent use of basal, prandial, or premixed insulin, or any insulin use within 6 months before randomization.\n\nCurrent use of sulfonylureas or meglitinides, or use within 3 months before randomization.\n\nCurrent use of anti-obesity pharmacotherapy or use within 6 months before randomization, including orlistat, naltrexone\u002Fbupropion, phentermine\u002Ftopiramate, or other agents with a primary anti-obesity indication.\n\nRecurrent severe hypoglycaemia or hypoglycaemia unawareness.\n\nPlanned initiation or dose escalation of glucose-lowering medication, anti-obesity medication, or systemic corticosteroids during the 24-week trial period in the judgment of the treating clinician.\n\nHistory of bariatric surgery at any time.\n\nGastrointestinal surgery other than appendectomy or uncomplicated cholecystectomy.\n\nActive inflammatory bowel disease, coeliac disease, microscopic colitis, chronic pancreatitis, malabsorption syndrome, or chronic severe gastrointestinal disease likely to affect absorption or trial adherence.\n\nAcute gastroenteritis within 4 weeks before randomization.\n\nColonoscopy bowel preparation within 12 weeks before randomization.\n\nFaecal microbiota transplantation within 12 months before randomization.\n\nActive or recent malignancy within 6 months, except adequately treated non-melanoma skin cancer.\n\nStage 3b to 5 chronic kidney disease, defined as estimated glomerular filtration rate less than 45 mL\u002Fmin\u002F1.73 m2.\n\nDecompensated liver disease or Child-Pugh class B\u002FC.\n\nALT or AST greater than 3 times the upper limit of normal at screening, unless judged clinically insignificant and approved by the investigator.\n\nKnown or suspected haemoglobinopathy that materially distorts HbA1c measurement or haemoglobin variant known to interfere with the central laboratory assay.\n\nBlood transfusion, significant blood loss greater than 250 mL, or erythropoiesis-stimulating agent therapy within 3 months before randomization.\n\nUntreated overt thyroid disease, or thyroid medication initiation or dose change within 3 months before randomization.\n\nUse of systemic corticosteroids within 4 weeks before randomization.\n\nUse of immunosuppressive medication or biologic\u002Fimmunomodulatory therapy within 5 half-lives before randomization.\n\nPregnancy or lactation; women of childbearing potential not willing to use effective contraception during the 24-week blinded period.\n\nSevere psychiatric illness or cognitive impairment that may compromise informed consent, safety, or adherence.\n\nActive eating disorder, defined operationally as a positive SCOFF screen with at least 2 affirmative responses at screening, or clinical diagnosis of anorexia nervosa, bulimia nervosa, or binge-eating disorder.\n\nHeavy alcohol use or active substance use disorder.\n\nCurrent very-low-calorie diet, ketogenic diet, medically supervised weight-loss diet, or other highly restrictive diet that excludes major food groups.\n\nCurrent cigarette smoking with intention to attempt cessation during the 24-week trial period; current users of nicotine-replacement or smoking-cessation pharmacotherapy initiated within 3 months before randomization.\n\nParticipation in another interventional clinical trial within 30 days before screening.\n\nKnown hypersensitivity or clinically significant intolerance to any component of the active product or placebo.\n\nInability or unwillingness to provide stool samples.\n\nAny condition that, in the investigator's opinion, would compromise participant safety or trial integrity.","ALL","18 Years","65 Years",{"count":94,"type":95},100,"ESTIMATED","INTERVENTIONAL",[98],"NA","AIM-MET is a randomized clinical study testing whether a fixed microbiome-targeted nutritional product can improve blood sugar control in adults with type 2 diabetes when used in addition to usual stable diabetes treatment.\n\nThe study will compare the active nutritional product with a matching placebo over 24 weeks. The product was designed using artificial intelligence before the study began, but the same fixed formulation will be used for all participants assigned to the active group. Artificial intelligence will not be used during the study to make individual treatment decisions, adjust dosing, or personalize the product.\n\nThe main question is whether participants receiving the active product have a greater reduction in HbA1c, a standard marker of average blood sugar levels, from the start of the study to Week 24 compared with participants receiving placebo. The study will also evaluate early blood sugar changes, fasting glucose, body weight and waist measurements in participants with baseline BMI of at least 25.0 kg\u002Fm2, safety, hypoglycaemia events, patient-reported outcomes, and gut microbiome features.\n\nThis is a 100-participant proof-of-concept study intended to estimate the size of the treatment signal, safety, feasibility, and parameters needed for a future larger confirmatory trial.",[101,102],"Type 2 Diabetes","Diabetes Mellitus Type 2",[104,105,106,107,108,109,110,111,112,113,114,88],"Type 2 diabetes","Type 2 diabetes mellitus","HbA1c","Glycemic response","Glycemic control","Microbiome","Gut microbiome","Nutritional intervention","AI-guided formulation design","Artificial intelligence","Randomized controlled trial","2026-06-05",{"date":117,"type":118},"2026-06-09","ACTUAL",{"date":120,"type":95},"2026-06-08",{"date":122,"type":95},"2027-06-30",{"name":5,"class":6},1]