Personalized lifestyle intervention for reversing type 2 diabetes
Development of Minimally Invasive Methodology for Diabetyping to Personalise Treatment to Realise Remission and Reversal of Type 2 Diabetes
This study is testing a new personalized lifestyle program to see if it can help people with type 2 diabetes improve their health by focusing on their unique needs.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 57 (estimated) |
| Ages | 40 Years and up |
| Sex | All |
| Sponsor | Tno Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (Leiden) |
| Trial ID | NCT06125119 on ClinicalTrials.gov |
What this trial studies
This study aims to develop a minimally invasive methodology for tailoring lifestyle interventions to individual subtypes of type 2 diabetes (T2D). By utilizing the Oral Glucose Tolerance Test (OGTT), the research seeks to identify specific organ dysfunctions that affect recovery of pancreatic beta-cell function. The goal is to create a Diabetyping Lifestyle Intervention (DLI) that can be applied on a larger scale, making it accessible to the over 1 million people with T2D. The study focuses on understanding how different individuals respond to lifestyle changes in diet and exercise, moving away from a one-size-fits-all approach.
Who should consider this trial
Good fit: Ideal candidates include individuals aged 40 and older with a diagnosis of type 2 diabetes or prediabetes and a BMI of 27 kg/m2 or higher.
Not a fit: Patients with type 1 diabetes, certain chronic conditions, or those undergoing specific medical treatments may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to more effective and personalized treatment strategies for individuals with type 2 diabetes, potentially achieving remission.
How similar studies have performed: While the concept of personalized interventions for diabetes is gaining traction, this specific approach using minimally invasive methods is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Diagnosed with (pre)diabetes type 2; * BMI ≥27 kg/m2, including a heterogenous group of people/with overweight/prediabetes (without glucose lowering medication), and/or type 2 diabetes with or without glucose lowering medication. * Aged 40 years or older * Able and willing to sign the informed consent form * Willing to comply with all study procedures Exclusion Criteria: * Type 1 diabetes * Latent Autoimmune Diabetes (LADA) * Skin allergy, eczema or known sensitivity for adhesives * History of bariatric weight loss surgery * Planned (bariatric) surgery during the 3 weeks monitoring period with the CGM * Active cancer or chemotherapy or radiation within 2 years prior to participation * A condition that would need an MRI during the 3 weeks monitoring period with the CGM * Planned holiday during the 3 week GCM monitoring period * (Night)shiftworkers * Pregnancy and lactation * Chronic medical condition, treatment, or medication other than diabetes that may affect glucose metabolism (HIV diagnosis, use of steroids or immunosuppressive drugs, etc.) * 4 or more alcoholic drinks per day on a regular basis or use of recreational drugs
Where this trial is running
Leiden
- Reinier Haga — Leiden, Netherlands (Recruiting)
Study contacts
- Study coordinator: Kristel Kamstra
- Email: kristel.kamstra@tno.nl
- Phone: +31611873786
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.