This randomized controlled trial investigates the effectiveness of AI-guided dietary supplement prescriptions compared to standard physician-guided prescriptions in managing Type 2 diabetes (T2D). The study includes 160 participants with T2D, aged 40-75, who will be randomly assigned to either the control group (standard physician-guided prescriptions) or the AI-guided group (prescriptions determined by GenAIS, an AI system by Triangel Scientific). The primary objective is to compare the reduction in HbA1c levels between the two groups over 6 months. Secondary outcomes include changes in fasting glucose, lipid profiles, body weight, BMI, hsCRP levels, and adherence to the dietary supplement regimen. The AI system integrates genetic, metabolic, and clinical data to provide personalized supplement recommendations, aiming to improve glycemic control and overall metabolic health.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
160
Participants receive supplements prescriptions from a physician based on current standard practices, which include biochemical markers, genetic data, and metabolic profiles.
Participants receive DS prescriptions determined by GenAIS, an AI system which considers genetic data, metabolic profiles, biochemical markers, and patient history.
Center of New Medical Technologies
Novosibirsk, Novosibisk Region, Russia
Change in HbA1c levels
Time frame: 180 days
Percent change in fasting venous blood glucose levels.
Time frame: 180 days
Percent change in high-sensitivity C-reactive protein
Time frame: 180 days
Percent change in cholesterol
Time frame: 180 days
Percent change in HDL-C,
Time frame: 180 days
Percent change in LDL-C
Time frame: 180 days
Percent change in triglycerides
Time frame: 180 days
Percent change in body weight
Time frame: 180 days
Incidence of any adverse effects related to supplements
Time frame: 180 days
Percent change in Body mass index (BMI)
Time frame: 180 days
Homeostasis Model Assessment of Insulin Resistance (HOMA-IR)
Time frame: 180 days
fasting insulin levels change (mU/mL)
Time frame: 180 days
Waist Circumference (cm) change
Time frame: 180 days
microalbuminuria (%) difference
Time frame: 180 days
changes in physical activity levels (hours/week)
Time frame: 180 days
Percentage of participants using antihypertensive medications (%)
Time frame: 180 days
Percentage of participants using antihypertensive medications (%).
Time frame: 180 days
Percentage of participants using lipid-lowering medications (%).
Time frame: 180 days
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