Using precision medicine to prevent type 2 diabetes
Precision Medicine for Preventing Type 2 Diabetes: a Step Forward (PRE-MED2)
NA · University of Pisa · NCT05147961
This study is testing if personalized health plans based on genetics and lifestyle can better help people at high risk of type 2 diabetes avoid getting the disease compared to standard advice.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 300 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | University of Pisa (other) |
| Locations | 2 sites (Pisa and 1 other locations) |
| Trial ID | NCT05147961 on ClinicalTrials.gov |
What this trial studies
This interventional study aims to explore the effectiveness of precision medicine in preventing type 2 diabetes by tailoring interventions based on individual genetic, metabolic, and lifestyle factors. It will involve 1200 high-risk participants who will be assessed using various questionnaires and wearable devices to gather data on their diet, physical activity, and metabolic profiles. The study will compare the outcomes of a mobile health intervention against traditional recommendations to determine which approach is more effective in delaying or preventing the onset of diabetes.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18-70 with a high risk of developing type 2 diabetes, such as those with obesity or a history of gestational diabetes.
Not a fit: Patients with an established diagnosis of diabetes or those with severe health conditions that may interfere with the study will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could significantly reduce the incidence of type 2 diabetes among high-risk individuals.
How similar studies have performed: Other studies have shown promise in using precision medicine and mobile health technologies for diabetes prevention, indicating a potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * age of 18-70 years * 12 points or more in the Finnish diabetes risk score or previous gestational diabetes or obese subjects * technology skills (computers, smartphones, tablets with internet connection) * absence of language barriers * ability to provide written informed consent to the study Exclusion Criteria: * Established diagnosis of diabetes * Pregnancy and breastfeeding * Renal or hepatic failure * Severe cardiovascular, neurological, hematological, endocrinological, gastrointestinal, nephrological or pneumological affections that may interfere with the study * Ongoing treatment with antidiabetics, diuretics, glucocorticoids, antypsychoticsoral contraceptives or other drugs known to affect glucose metabolism. * History of pancreatitis * Alcohol abuse or abuse of psychoactive substances * Subjects with mental disorders, or predictably unfit to understand and issue valid written informed consent to the study * Subjects with mental disorders, or not suitable for understanding and performing the tasks required by the study * Bariatric surgery * Current cancer or less than 6 months from the end of cancer treatment
Where this trial is running
Pisa and 1 other locations
- Azienda Ospedaliero-Universitaria Pisana — Pisa, Italy (RECRUITING)
- Stefano Del Prato — Pisa, Italy (ACTIVE_NOT_RECRUITING)
Study contacts
- Principal investigator: Stefano Del Prato, MD — Università di Pisa
- Study coordinator: Stefano Del Prato, MD
- Email: stefano.delprato@unipi.it
- Phone: +39050995103
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: PreDiabetes, Prediabetes, Diabetes prevention, Precision medicine, Circulating miRNA, Wereable device, Data integration, Obesity