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Completed

NCT Number: NCT06469658

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

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.

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Key information

Age range

40 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Center of New Medical Technologies

Novosibirsk, Novosibisk Region, 630090, Russia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. Change in HbA1c levels

    Time frame: 180 days

Secondary outcomes

  1. Percent change in fasting venous blood glucose levels.

    Time frame: 180 days

  2. Percent change in high-sensitivity C-reactive protein

    Time frame: 180 days

  3. Percent change in cholesterol

    Time frame: 180 days

  4. Percent change in HDL-C,

    Time frame: 180 days

  5. Percent change in LDL-C

    Time frame: 180 days

  6. Percent change in triglycerides

    Time frame: 180 days

  7. Percent change in body weight

    Time frame: 180 days

  8. Incidence of any adverse effects related to supplements

    Time frame: 180 days

  9. Percent change in Body mass index (BMI)

    Time frame: 180 days

  10. Homeostasis Model Assessment of Insulin Resistance (HOMA-IR)

    Time frame: 180 days

  11. fasting insulin levels change (mU/mL)

    Time frame: 180 days

  12. Waist Circumference (cm) change

    Time frame: 180 days

  13. microalbuminuria (%) difference

    Time frame: 180 days

  14. changes in physical activity levels (hours/week)

    Time frame: 180 days

  15. Percentage of participants using antihypertensive medications (%)

    Time frame: 180 days

  16. Percentage of participants using antihypertensive medications (%).

    Time frame: 180 days

  17. Percentage of participants using lipid-lowering medications (%).

    Time frame: 180 days

Sponsors and collaborators

Lead sponsor

S.LAB (SOLOWAYS)

Other

Collaborators

  • Center of New Medical Technologies
  • Triangel Scientific

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Jun 21, 2024
Registry last updated
Jul 3, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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