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

July 1, 2024 updated by: S.LAB (SOLOWAYS)

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

160

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Russian Federation
    • Novosibisk Region
      • Novosibirsk, Novosibisk Region, Russian Federation, 630090
        • Center of New Medical Technologies

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Group 1
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.
Experimental: Group 2
Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in HbA1c levels
Time Frame: 180 days
180 days

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

S.LAB (SOLOWAYS)

Collaborators

Center of New Medical Technologies
Triangel Scientific

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 2, 2024

Primary Completion (Actual)

May 15, 2024

Study Completion (Actual)

June 3, 2024

Study Registration Dates

First Submitted

June 12, 2024

First Submitted That Met QC Criteria

June 17, 2024

First Posted (Actual)

June 21, 2024

Study Record Updates

Last Update Posted (Actual)

July 3, 2024

Last Update Submitted That Met QC Criteria

July 1, 2024

Last Verified

June 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SW014

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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