RecruitingNot Applicable

AIM-MET: AI-Guided Microbiome-Targeted Nutrition for Glycemic Improvement in Type 2 Diabetes

Turkey (Türkiye)100 participantsStarted 2026-06-08

Plain-language summary

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.

Who can participate

Age range

18 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 ini…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1This trial uses AI-guided microbiome-targeted nutrition to try to lower HbA1c over 24 weeks — how does that approach compare to the dietary guidance I'm already getting, and could it interfere with any diabetes medications I'm currently taking?
2Since this trial is listed as Phase NA, which sometimes means it's a feasibility or pilot study rather than a large efficacy trial, does that mean there's less established safety and benefit data behind this approach than there would be for a standard Phase 2 or Phase 3 trial?
3The trial is measuring changes in HbA1c at 24 weeks — given where my HbA1c is right now, do you think 24 weeks on a nutrition-focused study is a realistic timeline for me, or would starting a proven medication adjustment be a more urgent priority?
4What does 'microbiome-targeted nutrition' actually involve day-to-day — am I likely to be asked to follow a specific diet, take supplements, or submit stool samples — and is that level of commitment realistic given my current schedule and health situation?
5Are there standard-of-care dietary or lifestyle interventions I should try first before considering an experimental AI-guided approach like this one, or does my current situation make this trial worth discussing as a potential option?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in HbA1c from baseline to Week 24

Timeframe: Baseline to Week 24

Trial details

NCT IDNCT07622628

SponsorENBIOSIS BIOTECHNOLOGIES

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2027-03-30

Contact for this trial

Varol TUNALI, Dr.

+905556303231 vtunali@enbiosis.com

View on ClinicalTrials.gov More Type 2 Diabetes trials