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

NCT06469658 | Completed

• 1 other identifier: SW014
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes

Keywords

AI-guided dietary supplementation; Personalized supplementation; HbA1c reduction; Genetic and metabolic profiling

Outcome Measures

Primary Outcomes (1)

• Change in HbA1c levels

  180 days

Secondary Outcomes (17)

• Percent change in fasting venous blood glucose levels.

  180 days

• Percent change in high-sensitivity C-reactive protein

  180 days

• Percent change in cholesterol

  180 days

• Percent change in HDL-C,

  180 days

• Percent change in LDL-C

  180 days

Study Arms (2)

Group 1

ACTIVE COMPARATOR

Other: The standard practice dietary supplements intervention

Group 2

EXPERIMENTAL

Other: The AI-guided practice dietary supplements group

Interventions

The standard practice dietary supplements intervention OTHER

Participants receive supplements prescriptions from a physician based on current standard practices, which include biochemical markers, genetic data, and metabolic profiles.

Group 1

The AI-guided practice dietary supplements group OTHER

Participants receive DS prescriptions determined by GenAIS, an AI system which considers genetic data, metabolic profiles, biochemical markers, and patient history.

Group 2

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• S.LAB (SOLOWAYS): lead
• Triangel Scientific: collaborator
• Center of New Medical Technologies: collaborator

Study Sites (1)

Center of New Medical Technologies

Novosibirsk, Novosibisk Region, 630090, Russia

Location

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 12, 2024
• First Posted: June 21, 2024
• Study Start: February 2, 2024
• Primary Completion: May 15, 2024
• Study Completion: June 3, 2024
• Last Updated: July 3, 2024

Record last verified: 2024-06

Locations

RU (1)