AIM-MET: AI-Guided Microbiome-Targeted Nutrition for Glycemic Improvement in Type 2 Diabetes
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorENBIOSIS BIOTECHNOLOGIES
About this 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
None
Trial design
Design model
Parallel
Treatments tested in this trial
Microbiome-targeted oral food supplement
Dietary supplementFixed 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.
Matching placebo oral supplement
Dietary supplementMatching 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.
Treatment groups
100 Participants
are divided into 2 treatment groupsGroup A: Microbiome-targeted oral food supplementExperimental treatment 1 intervention
Group B: Matching placebo oral supplementPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Change in HbA1c from baseline to Week 24
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.
Time frame
Baseline to Week 24Secondary outcomes
1
Proportion of participants achieving HbA1c reduction of at least 0.5 percentage points at Week 24
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.
Time frame
Baseline to Week 242
Proportion of participants achieving HbA1c reduction of at least 0.3 percentage points at Week 24
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.
Time frame
Baseline to Week 243
Change in HbA1c from baseline to Week 12
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.
Time frame
Baseline to Week 124
Change in fasting plasma glucose from baseline to Week 24
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.
Time frame
Baseline to Week 24Other outcomes
1
Change in fasting plasma glucose from baseline to Week 12
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.
Time frame
Baseline to Week 122
Achievement of HbA1c less than 6.5% at Week 24
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.
Time frame
Baseline to Week 243
Absolute change in body weight at Week 12 and Week 24 by BMI subgroup
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.
Time frame
Baseline to Week 12 and Week 244
Treatment-emergent adverse events and serious adverse events
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.
Time frame
Baseline through Week 28Sponsors and contacts
Click on the lead sponsor to view all of their trials.
ENBIOSIS BIOTECHNOLOGIES
Lead sponsor
Bakırçay University, Faculty of Medicine
Collaborator
Aydin Adnan Menderes University
Collaborator
Buca Seyfi Demirsoy State Hospital
Collaborator
Izmir University of Economics
Collaborator
Source ClinicalTrials.gov