Status:
UNKNOWN
Development of PI-ML Algorithm for Prediction of the Real-time Risk for Developing Pre-diabetes
Lead Sponsor:
Jelizaveta Sokolovska
Collaborating Sponsors:
Spindox Labs
The National Research Council, Italy
Conditions:
Prediabetic State
Body Weight
Eligibility:
All Genders
18-65 years
Brief Summary
In this prospective, non-randomized, monocentric study, data will be collected from otherwise healthy individuals with overweight/obese grade I to increase data availability in the pre-diabetes field ...
Detailed Description
Noncommunicable diseases (NCDs) such as cancer, cardiovascular diseases, and diabetes represent 74% of the disease burden globally and are the major causes of preventable premature deaths. (1,2). Dia...
Eligibility Criteria
Inclusion
- Healthy adult volunteers (age ≥ 18 years old);
- Overweight (BMI 25 - 29.9 kg/m2) and obese grade I individuals (with BMI 30 - 34.9 kg/m2);
- Written consent of the participant after being informed;
- Ownership of a smartphone running Android or iOS.
Exclusion
- Non-compliance;
- Ongoing treatment with immunosuppressive and/or anti-inflammatory medications (NSAIDs, glucocorticoids, chemotherapy, biologicals);
- Ongoing treatment with glucose lowering drugs, except if anti-diabetic medication has not been stopped - for metformin one month, for GLP-1 RA, tirzepatide - two months prior enrolment;
- Presence of autoimmune and/or inflammatory disease (autoimmune thyroid disease, psoriasis, inflammatory bowel disease);
- Skin conditions hindering application of continuous glucose monitoring systems;
- Diabetes or prediabetes as diagnosed by ADA/WHO criteria according to fasting glucose and/or HbA1c;
- High risk alcohol consumption - according to NIAAA - National Institute on Alcohol Abuse and Alcoholism (for men - more than 4 drinks on any day or more than 14 drinks per week; for women - more than 3 drinks on any day or more than 7 drinks per week);
- Factors otherwise limiting the participation in the study according to the judgement of the investigator;
- Pregnancy or intention to get pregnant during the study timeline.
Key Trial Info
Start Date :
January 29 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
March 31 2025
Estimated Enrollment :
75 Patients enrolled
Trial Details
Trial ID
NCT06195566
Start Date
January 29 2024
End Date
March 31 2025
Last Update
January 8 2024
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
University of Latvia, Faculty of Medicine
Riga, Latvia