Status:
RECRUITING
Development of Minimally Invasive Methodology for Diabetyping to Personalise Treatment to Realise Remission and Reversal of Type 2 Diabetes
Lead Sponsor:
TNO
Conditions:
Type 2 Diabetes
Eligibility:
All Genders
40+ years
Brief Summary
Rationale: Lifestyle changes in diet and exercise can reverse type 2 diabetes (T2D), also referred to as T2D remission. Although combined lifestyle interventions for T2D remission are promising, not a...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 18 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
March 1 2025
Estimated Enrollment :
57 Patients enrolled
Trial Details
Trial ID
NCT06125119
Start Date
March 18 2024
End Date
March 1 2025
Last Update
April 15 2024
Active Locations (1)
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1
Reinier Haga
Leiden, Netherlands