Personalized Management of Type 2 Diabetes Using AI-Guided (GenAIS TM) Dietary Supplementation

Not Applicable

Completed

• Conditions: Diabetes
• Interventions: Other: The standard practice dietary supplements intervention; Other: The AI-guided practice dietary supplements group

• Registration Number: NCT06469658
• Lead Sponsor: S.LAB (SOLOWAYS)

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-02-02
• Primary Completion: 2024-05-15
• Status Verified: 2024-06
• Study Completion: 2024-06-03
• Study First Submitted: 2024-06-12
• Study First Submitted QC: 2024-06-17
• Study First Posted: 2024-06-21
• Last Update Submitted: 2024-07-01
• Last Update Posted: 2024-07-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 160

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 1	The standard practice dietary supplements intervention	-
Group 2	The AI-guided practice dietary supplements group	-

Primary Outcome Measures

Name	Time	Method
Change in HbA1c levels	180 days

Secondary Outcome Measures

Name	Time	Method
Percent change in body weight	180 days
Homeostasis Model Assessment of Insulin Resistance (HOMA-IR)	180 days
Percentage of participants using antihypertensive medications (%)	180 days
Percent change in cholesterol	180 days
Percent change in triglycerides	180 days
changes in physical activity levels (hours/week)	180 days
Percentage of participants using lipid-lowering medications (%).	180 days
Percent change in HDL-C,	180 days
Percent change in LDL-C	180 days
Incidence of any adverse effects related to supplements	180 days
Percentage of participants using antihypertensive medications (%).	180 days
fasting insulin levels change (mU/mL)	180 days
Waist Circumference (cm) change	180 days
microalbuminuria (%) difference	180 days
Percent change in high-sensitivity C-reactive protein	180 days
Percent change in Body mass index (BMI)	180 days
Percent change in fasting venous blood glucose levels.	180 days

Trial Locations

Locations (1)

Center of New Medical Technologies; 🇷🇺 Novosibirsk, Novosibisk Region, Russian Federation