DiabetesNCT06469658
Personalized Management of Type 2 Diabetes Using AI-Guided (GenAIS TM) Dietary Supplementation
A study testing The standard practice dietary supplements intervention and The AI-guided practice dietary supplements group in people with Diabetes, run by S.LAB (SOLOWAYS) at 1 site in Russia.
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). Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Diabetes
- What is being tested?
- The standard practice dietary supplements intervention and The AI-guided practice dietary supplements group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteRussia
- Study dates
- 2 Feb 2024to 3 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Russia1 site
Center of New Medical Technologies
Novosibirsk, Novosibisk Region, 630090
About this study
Official title: 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.
- Conditions
- Diabetes
- Being tested
- The standard practice dietary supplements intervention, The AI-guided practice dietary supplements group
- Keywords
- AI-guided dietary supplementation, Personalized supplementation, HbA1c reduction, Genetic and metabolic profiling
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The standard practice dietary supplements interventionOther
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 groupOther
Participants receive DS prescriptions determined by GenAIS, an AI system which considers genetic data, metabolic profiles, biochemical markers, and patient history.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Active comparator | Not described Receives: Other: The standard practice dietary supplements intervention |
| Group 2 | Experimental | Not described Receives: Other: The AI-guided practice dietary supplements group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in HbA1c levels
Measured: 180 days
Secondary outcomes (17)
Percent change in fasting venous blood glucose levels.
Measured: 180 days
Percent change in high-sensitivity C-reactive protein
Measured: 180 days
Percent change in cholesterol
Measured: 180 days
Percent change in HDL-C,
Measured: 180 days
Percent change in LDL-C
Measured: 180 days
Percent change in triglycerides
Measured: 180 days
Percent change in body weight
Measured: 180 days
Incidence of any adverse effects related to supplements
Measured: 180 days
Percent change in Body mass index (BMI)
Measured: 180 days
Homeostasis Model Assessment of Insulin Resistance (HOMA-IR)
Measured: 180 days
fasting insulin levels change (mU/mL)
Measured: 180 days
Waist Circumference (cm) change
Measured: 180 days
microalbuminuria (%) difference
Measured: 180 days
changes in physical activity levels (hours/week)
Measured: 180 days
Percentage of participants using antihypertensive medications (%)
Measured: 180 days
Percentage of participants using antihypertensive medications (%).
Measured: 180 days
Percentage of participants using lipid-lowering medications (%).
Measured: 180 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2024
- Study start2 Feb 2024
- Primary completion15 May 2024
- Study completion3 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- S.LAB (SOLOWAYS)
- Sponsor type
- University, hospital or other
- Collaborators
- Triangel Scientific, Center of New Medical Technologies
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06469658
- Sponsor's protocol ID
- SW014
- Status last verified
- Jun 2024
- First submitted
- 12 Jun 2024
- Last updated
- 3 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Personalized Management of Type 2 Diabetes Using AI-Guided (GenAIS TM) Dietary Supplementation: A Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT06469658
- Acronym / sponsor ID
- SW014
- Conditions
- Diabetes
- Keywords
- AI-guided dietary supplementation, Personalized supplementation, HbA1c reduction, Genetic and metabolic profiling
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- S.LAB (SOLOWAYS)University, hospital or other
- Collaborators
- Triangel Scientific, Center of New Medical Technologies
- Study start
- 2 Feb 2024 (actual)
- Primary completion
- 15 May 2024 (actual)
- Study completion
- 3 Jun 2024 (actual)
- First posted
- 21 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Active comparator | Other: The standard practice dietary supplements intervention |
| Group 2 | Experimental | Other: The AI-guided practice dietary supplements group |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| The standard practice dietary supplements interventionParticipants receive supplements prescriptions from a physician based on current standard practices, which include biochemical markers, genetic data, and metabolic profiles. | Other | Group 1 |
| The AI-guided practice dietary supplements groupParticipants receive DS prescriptions determined by GenAIS, an AI system which considers genetic data, metabolic profiles, biochemical markers, and patient history. | Other | Group 2 |
Primary outcome
Change in HbA1c levels
Time frame: 180 days
17 secondary outcomes
Percent change in fasting venous blood glucose levels.
Time frame: 180 days
Percent change in high-sensitivity C-reactive protein
Time frame: 180 days
Percent change in cholesterol
Time frame: 180 days
Percent change in HDL-C,
Time frame: 180 days
Percent change in LDL-C
Time frame: 180 days
Percent change in triglycerides
Time frame: 180 days
Percent change in body weight
Time frame: 180 days
Incidence of any adverse effects related to supplements
Time frame: 180 days
Percent change in Body mass index (BMI)
Time frame: 180 days
Homeostasis Model Assessment of Insulin Resistance (HOMA-IR)
Time frame: 180 days
fasting insulin levels change (mU/mL)
Time frame: 180 days
Waist Circumference (cm) change
Time frame: 180 days
microalbuminuria (%) difference
Time frame: 180 days
changes in physical activity levels (hours/week)
Time frame: 180 days
Percentage of participants using antihypertensive medications (%)
Time frame: 180 days
Percentage of participants using antihypertensive medications (%).
Time frame: 180 days
Percentage of participants using lipid-lowering medications (%).
Time frame: 180 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The standard practice dietary supplements intervention and The AI-guided practice dietary supplements group in people with Diabetes, run by S.LAB (SOLOWAYS) at 1 site in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in HbA1c levels (time frame: 180 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jul 2024.