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

Diabetes Clinical Trial

Official title:

Personalized Management of Type 2 Diabetes Using AI-Guided (GenAIS TM) Dietary Supplementation: A Randomized Controlled Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06469658
• Other study ID #: SW014
• Status: Completed
• Phase: N/A
• Start date: February 2, 2024
• Est. completion date: June 3, 2024

Study information

• Verified date: June 2024
• Source: S.LAB (SOLOWAYS)
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 160
• Est. completion date: June 3, 2024
• Est. primary completion date: May 15, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes
• Diabetes Mellitus

Intervention

Other:
• The standard practice dietary supplements intervention
Participants receive supplements prescriptions from a physician based on current standard practices, which include biochemical markers, genetic data, and metabolic profiles.
• The AI-guided practice dietary supplements group
Participants receive DS prescriptions determined by GenAIS, an AI system which considers genetic data, metabolic profiles, biochemical markers, and patient history.

Locations

Country	Name	City	State
Russian Federation	Center of New Medical Technologies	Novosibirsk	Novosibisk Region

Sponsors (3)

Lead Sponsor	Collaborator
S.LAB (SOLOWAYS)	Center of New Medical Technologies, Triangel Scientific

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in HbA1c levels		180 days
Secondary	Percent change in fasting glucose levels.		180 days
Secondary	Percent change in high-sensitivity C-reactive protein		180 days
Secondary	Percent change in cholesterol		180 days
Secondary	Percent change in HDL-C,		180 days
Secondary	Percent change in LDL-C		180 days
Secondary	Percent change in triglycerides		180 days
Secondary	Percent change in body weight		180 days
Secondary	Incidence of any adverse effects related to supplements		180 days
Secondary	Percent change in Body mass index (BMI)		180 days