AIM-MET: AI-Guided Microbiome-Targeted Nutrition for Glycemic Improvement in Type 2 Diabetes (AIM-MET)
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 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.
The 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.
The 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/m2, safety, hypoglycaemia events, patient-reported outcomes, and gut microbiome features.
This 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.
Descripción general del estudio
Estado
Condiciones
Descripción detallada
Type 2 diabetes is commonly managed with lifestyle measures and glucose-lowering medications, but many individuals continue to have residual hyperglycaemia despite stable treatment. Nutritional interventions that target the gut microbiome may provide a safe adjunctive approach if they can improve glycaemic control without replacing standard diabetes care.
The gut microbiome may influence glucose regulation through several biological pathways, including short-chain fatty acid production, bile acid metabolism, intestinal barrier function, low-grade inflammation, incretin signalling, and other host-microbe interactions. These mechanisms provide the rationale for evaluating a microbiome-targeted nutritional intervention in adults with type 2 diabetes.
The investigational product is a fixed AI-guided microbiome-targeted nutritional formulation. The artificial intelligence methodology was used before the clinical trial to support formulation design, including ingredient and dose selection from candidate microbiome-active compounds. The output of this process is one fixed formulation that is locked before participant enrolment and is identical for all participants assigned to the active intervention arm. The artificial intelligence system is not used during the trial for participant-level prediction, diagnosis, clinical decision-making, dosing, personalization, or formulation adjustment. Therefore, the clinical study evaluates the fixed nutritional product, not the independent clinical performance of an artificial intelligence system.
Participants are randomized in a 1:1 ratio to receive either the active nutritional intervention or a matching placebo for 24 weeks. Both groups receive identical structured lifestyle counselling and continue stable background glucose-lowering therapy as clinically appropriate. The placebo is matched to the active product in appearance, taste, smell, packaging, administration schedule, and storage conditions, and is intended to be microbiome- and glycaemia-neutral.
The primary clinical assessment is the change in HbA1c from baseline to Week 24. Week 24 was selected because HbA1c reflects average glycaemia over the preceding 2 to 3 months and is therefore appropriate for evaluating a gradually acting nutritional and microbiome-targeted intervention. The study also evaluates supportive glycaemic, anthropometric, safety, patient-reported, and microbiome-related measures.
This 100-participant proof-of-concept trial is designed to detect a clinically meaningful HbA1c signal and to estimate safety, feasibility, variability, and effect-size parameters for a future larger confirmatory trial. The study is not intended to replace standard diabetes care or to assess the investigational product as a substitute for clinically indicated glucose-lowering medication.
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Varol TUNALI, Dr.
- Número de teléfono: +905556303231
- Correo electrónico: vtunali@enbiosis.com
Copia de seguridad de contactos de estudio
- Nombre: Buğra Yağmur, Mr
- Número de teléfono: +90 505 632 82 82
- Correo electrónico: byagmur@enbiosis.com
Ubicaciones de estudio
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Izmir, Turquía (Türkiye)
- Reclutamiento
- Bakırçay University Faculty of Medicine Endocrinology Department
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Contacto:
- Sedat Güney, Dr.
- Número de teléfono: +90 554 844 92 66
- Correo electrónico: sedat.guney@cbu.edu.tr
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria:
Adults aged 18 to 65 years.
Established diagnosis of type 2 diabetes mellitus documented in the medical record, supported by American Diabetes Association diagnostic criteria on at least one prior occasion.
HbA1c 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.
Body mass index 18.5 to 40.0 kg/m2 at screening.
Stable background glucose-lowering therapy for at least 3 months before randomization, restricted to metformin, a DPP-4 inhibitor, and/or an SGLT2 inhibitor, either alone or in combination.
Documented body-weight stability, defined as no more than +/-5% or +/-3 kg, whichever is smaller, self-reported body-weight change during the 3 months before screening.
Willing and able to provide written informed consent.
Willing and able to comply with trial visits, study product use, fasting blood sampling, stool sampling, and the study assessment schedule.
Willing to receive standardized lifestyle counselling during the 24-week blinded period and to maintain stable background diabetes management as clinically directed.
No systemic antibiotic use within 8 weeks before randomization.
No probiotic, prebiotic, synbiotic, or postbiotic supplement use within 8 weeks before randomization.
Stable 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.
Exclusion Criteria:
Type 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.
HbA1c less than 6.8% or greater than 8.2% at screening.
Current use of GLP-1 receptor agonists or GLP-1/GIP co-agonists, or use within 12 months before randomization.
Current use of basal, prandial, or premixed insulin, or any insulin use within 6 months before randomization.
Current use of sulfonylureas or meglitinides, or use within 3 months before randomization.
Current use of anti-obesity pharmacotherapy or use within 6 months before randomization, including orlistat, naltrexone/bupropion, phentermine/topiramate, or other agents with a primary anti-obesity indication.
Recurrent severe hypoglycaemia or hypoglycaemia unawareness.
Planned 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.
History of bariatric surgery at any time.
Gastrointestinal surgery other than appendectomy or uncomplicated cholecystectomy.
Active inflammatory bowel disease, coeliac disease, microscopic colitis, chronic pancreatitis, malabsorption syndrome, or chronic severe gastrointestinal disease likely to affect absorption or trial adherence.
Acute gastroenteritis within 4 weeks before randomization.
Colonoscopy bowel preparation within 12 weeks before randomization.
Faecal microbiota transplantation within 12 months before randomization.
Active or recent malignancy within 6 months, except adequately treated non-melanoma skin cancer.
Stage 3b to 5 chronic kidney disease, defined as estimated glomerular filtration rate less than 45 mL/min/1.73 m2.
Decompensated liver disease or Child-Pugh class B/C.
ALT or AST greater than 3 times the upper limit of normal at screening, unless judged clinically insignificant and approved by the investigator.
Known or suspected haemoglobinopathy that materially distorts HbA1c measurement or haemoglobin variant known to interfere with the central laboratory assay.
Blood transfusion, significant blood loss greater than 250 mL, or erythropoiesis-stimulating agent therapy within 3 months before randomization.
Untreated overt thyroid disease, or thyroid medication initiation or dose change within 3 months before randomization.
Use of systemic corticosteroids within 4 weeks before randomization.
Use of immunosuppressive medication or biologic/immunomodulatory therapy within 5 half-lives before randomization.
Pregnancy or lactation; women of childbearing potential not willing to use effective contraception during the 24-week blinded period.
Severe psychiatric illness or cognitive impairment that may compromise informed consent, safety, or adherence.
Active 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.
Heavy alcohol use or active substance use disorder.
Current very-low-calorie diet, ketogenic diet, medically supervised weight-loss diet, or other highly restrictive diet that excludes major food groups.
Current 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.
Participation in another interventional clinical trial within 30 days before screening.
Known hypersensitivity or clinically significant intolerance to any component of the active product or placebo.
Inability or unwillingness to provide stool samples.
Any condition that, in the investigator's opinion, would compromise participant safety or trial integrity.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Cuidados de apoyo
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Cuadruplicar
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Experimental: Microbiome-targeted oral food supplement
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.
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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.
Otros nombres:
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Comparador de placebos: Matching placebo oral supplement
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.
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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.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Change in HbA1c from baseline to Week 24
Periodo de tiempo: Baseline to Week 24
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HbA1c is a blood test that reflects average blood glucose levels over approximately the previous 2 to 3 months.
HbA1c is measured using an NGSP-certified central laboratory assay and reported as a percentage.
The outcome is the absolute change in HbA1c, in percentage points, from baseline to Week 24.
A greater reduction indicates improved glycaemic control.
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Baseline to Week 24
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Proportion of participants achieving HbA1c reduction of at least 0.5 percentage points at Week 24
Periodo de tiempo: Baseline to Week 24
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This outcome measures the proportion of participants whose HbA1c decreases by at least 0.5 percentage points from baseline to Week 24.
HbA1c is a blood test reflecting average glucose levels over approximately 2 to 3 months and is measured using an NGSP-certified central laboratory assay.
Participants who meet or exceed this reduction threshold are counted as responders.
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Baseline to Week 24
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Proportion of participants achieving HbA1c reduction of at least 0.3 percentage points at Week 24
Periodo de tiempo: Baseline to Week 24
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This outcome measures the proportion of participants whose HbA1c decreases by at least 0.3 percentage points from baseline to Week 24.
HbA1c is measured using an NGSP-certified central laboratory assay and reported as a percentage.
Participants who meet or exceed this reduction threshold are counted as responders.
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Baseline to Week 24
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Change in HbA1c from baseline to Week 12
Periodo de tiempo: Baseline to Week 12
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HbA1c is a blood test that reflects average blood glucose levels over approximately the previous 2 to 3 months.
This outcome measures the absolute change in HbA1c, in percentage points, from baseline to Week 12.
This earlier time point is used to describe the early trajectory of glycaemic response.
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Baseline to Week 12
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Change in fasting plasma glucose from baseline to Week 24
Periodo de tiempo: Baseline to Week 24
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Fasting plasma glucose is a blood measure of glucose concentration after an overnight fast of at least 8 hours.
Baseline and Week 24 values are each defined as the mean of two fasting plasma glucose samples drawn within a 7-day window.
The outcome is the absolute change from baseline to Week 24.
A greater reduction indicates improved fasting glycaemia.
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Baseline to Week 24
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Achievement of HbA1c less than 7.0% at Week 24 among participants with baseline HbA1c at least 7.0%
Periodo de tiempo: Baseline to Week 24
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This outcome measures the proportion of participants with baseline HbA1c of at least 7.0% who achieve HbA1c less than 7.0% at Week 24.
HbA1c is measured using an NGSP-certified central laboratory assay and reported as a percentage.
Participants below the 7.0% threshold at Week 24 are counted as achieving this outcome.
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Baseline to Week 24
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Percent change in body weight at Week 24 in participants with baseline BMI at least 25.0 kg/m2
Periodo de tiempo: Baseline to Week 24
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This outcome is assessed only in participants with baseline body mass index, or BMI, of at least 25.0 kg/m2.
Body weight is measured using a standardized calibrated scale procedure.
Percent change is calculated as 100 x (Week 24 body weight - baseline body weight) / baseline body weight.
A negative value indicates weight reduction.
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Baseline to Week 24
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Change in waist circumference at Week 24 in participants with baseline BMI at least 25.0 kg/m2
Periodo de tiempo: Baseline to Week 24
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This outcome is assessed only in participants with baseline BMI of at least 25.0 kg/m2.
Waist circumference is measured using a standardized non-stretch tape procedure.
The outcome is the absolute change in waist circumference from baseline to Week 24, reported in centimeters.
A negative value indicates a reduction in waist circumference.
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Baseline to Week 24
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Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Change in fasting plasma glucose from baseline to Week 12
Periodo de tiempo: Baseline to Week 12
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Fasting plasma glucose is a blood measure of glucose concentration after an overnight fast of at least 8 hours.
This outcome uses a single fasting plasma glucose sample at Week 12 and measures the absolute change from baseline to Week 12.
A greater reduction indicates improved fasting glycaemia.
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Baseline to Week 12
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Achievement of HbA1c less than 6.5% at Week 24
Periodo de tiempo: Baseline to Week 24
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This outcome measures the proportion of participants who achieve HbA1c less than 6.5% at Week 24.
HbA1c is a blood test that reflects average glucose levels over approximately 2 to 3 months and is reported as a percentage.
Participants below the 6.5% threshold at Week 24 are counted as achieving this outcome.
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Baseline to Week 24
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Absolute change in body weight at Week 12 and Week 24 by BMI subgroup
Periodo de tiempo: Baseline to Week 12 and Week 24
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Body weight is measured in kilograms using a standardized calibrated scale procedure.
Absolute change in body weight is reported separately for participants with baseline BMI at least 25.0 kg/m2 and participants with baseline BMI less than 25.0 kg/m2.
Body-weight trajectory in participants with BMI less than 25.0 kg/m2 is interpreted as a safety signal, not as a weight-loss efficacy outcome.
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Baseline to Week 12 and Week 24
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Treatment-emergent adverse events and serious adverse events
Periodo de tiempo: Baseline through Week 28
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This outcome measures the number and type of adverse events that occur after starting the study product.
Treatment-emergent adverse events, serious adverse events, discontinuations due to adverse events, and product-related adverse events are collected throughout the trial.
Events are coded using MedDRA, and severity is graded using CTCAE v5.0.
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Baseline through Week 28
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Hypoglycaemia adverse events of special interest
Periodo de tiempo: Baseline through Week 24
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Hypoglycaemia means low blood glucose.
Events are captured using ADA-aligned categories: Level 1 is glucose less than 70 mg/dL and at least 54 mg/dL; Level 2 is glucose less than 54 mg/dL; and Level 3 is severe hypoglycaemia requiring assistance from another person, regardless of measured glucose value.
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Baseline through Week 24
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Change in Diabetes Distress Scale score
Periodo de tiempo: Baseline to Week 12 and Week 24
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Diabetes-related distress is assessed using the 17-item Diabetes Distress Scale.
The total mean score ranges from 1 to 6, with higher scores indicating greater diabetes-related distress.
The outcome is the change in score from baseline to Week 12 and Week 24.
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Baseline to Week 12 and Week 24
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Change in WHO-5 Well-Being Index score
Periodo de tiempo: Baseline to Week 12 and Week 24
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Well-being is assessed using the WHO-5 Well-Being Index.
The raw score ranges from 0 to 25, with higher scores indicating better well-being.
The outcome is the change in score from baseline to Week 12 and Week 24.
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Baseline to Week 12 and Week 24
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Gut microbiome alpha diversity
Periodo de tiempo: Baseline to Week 24
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Alpha diversity describes the variety of microorganisms within an individual stool sample.
Prespecified alpha diversity metrics are defined in the Microbiome Analysis Plan.
The outcome evaluates change in alpha diversity from baseline to Week 24.
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Baseline to Week 24
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Gut microbiome beta diversity
Periodo de tiempo: Baseline to Week 24
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Beta diversity describes differences in gut microbial community composition between stool samples.
Prespecified distance metrics and statistical models are defined in the Microbiome Analysis Plan.
The outcome evaluates microbiome community changes from baseline to Week 24.
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Baseline to Week 24
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Silla de estudio: Engin Güney, Prof. Dr., Aydın Adnan Menderes University Faculty of Medicine Endocrinology Department
- Investigador principal: Varol Tunali, Dr., Enbiosis Biotechnology Limited
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- Enbiosis_AIM-MET
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
Marco de tiempo para compartir IPD
Criterios de acceso compartido de IPD
Tipo de información de apoyo para compartir IPD
- PROTOCOLO DE ESTUDIO
- SAVIA
- RSC
Información sobre medicamentos y dispositivos, documentos del estudio
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Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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