Clinical trial NCT06469658: Personalized Management of Type 2 Diabetes Using AI-Guided (GenAIS TM) Dietary Supplementation
Official title: Personalized Management of Type 2 Diabetes Using AI-Guided (GenAIS TM) Dietary Supplementation: A Randomized Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes
Keywords: AI-guided dietary supplementation
Personalized supplementation
HbA1c reduction
Genetic and metabolic profiling
Lead sponsor: S.LAB (SOLOWAYS)
Sponsor class: OTHER
Collaborators: name: Triangel Scientific
name: Center of New Medical Technologies
First posted: 2024-06-21
Enrollment: 160
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* Age between 40 and 75 years.
* Diagnosed with Type 2 diabetes (HbA1c between 7.0% and 10.0%).
* Stable anti-diabetic medication regimen for at least 3 months prior to the study.
* Willingness to provide genetic and metabolic data.

Exclusion Criteria:

* Type 1 diabetes or other specific types of diabetes.
* Significant renal, hepatic, or cardiovascular diseases.
* Use of dietary supplements that affect glucose metabolism within the last 3 months.
* Pregnancy or breastfeeding

Primary outcomes:
measure: Change in HbA1c levels
timeFrame: 180 days
Secondary outcomes:
measure: Percent change in fasting venous blood glucose levels.
timeFrame: 180 days
measure: Percent change in high-sensitivity C-reactive protein
timeFrame: 180 days
measure: Percent change in cholesterol
timeFrame: 180 days
measure: Percent change in HDL-C,
timeFrame: 180 days
measure: Percent change in LDL-C
timeFrame: 180 days
measure: Percent change in triglycerides
timeFrame: 180 days
measure: Percent change in body weight
timeFrame: 180 days
measure: Incidence of any adverse effects related to supplements
timeFrame: 180 days
measure: Percent change in Body mass index (BMI)
timeFrame: 180 days
measure: Homeostasis Model Assessment of Insulin Resistance (HOMA-IR)
timeFrame: 180 days
measure: fasting insulin levels change (mU/mL)
timeFrame: 180 days
measure: Waist Circumference (cm) change
timeFrame: 180 days
measure: microalbuminuria (%) difference
timeFrame: 180 days
measure: changes in physical activity levels (hours/week)
timeFrame: 180 days
measure: Percentage of participants using antihypertensive medications (%)
timeFrame: 180 days
measure: Percentage of participants using antihypertensive medications (%).
timeFrame: 180 days
measure: Percentage of participants using lipid-lowering medications (%).
timeFrame: 180 days
Other outcomes:
Locations:
city: Novosibirsk
country: Russian Federation
facility: Center of New Medical Technologies
state: Novosibisk Region
Study officials:
References: