Status:
NOT_YET_RECRUITING
Lifestyle Intervention for Type 2 Diabetes in Primary Care (CREDOenAP)
Lead Sponsor:
Parc Sanitari Pere Virgili
Conditions:
Type 2 Diabetes Mellitus (T2DM)
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief Summary
The purpose of this clinical trial is to determine whether an intensive lifestyle intervention can achieve remission of type 2 diabetes mellitus (T2DM) in adult patients treated in primary care. The m...
Eligibility Criteria
Inclusion
- Signed informed consent.
- Men and women aged 18-80 years, inclusive.
- Confirmed diagnosis of T2DM according to recognized diagnostic criteria
- Most recent recorded hemoglobin A1c (HbA1c) \> 6.5%.
- Body Mass Index (BMI) greater than 27 kg/m².
Exclusion
- Failure to meet the diagnostic criteria for T2DM in the screening laboratory tests.
- Being dependent for basic activities of daily living (Barthel score ≤ 90 points).
- Lack of willingness to cooperate with the follow-up of the lifestyle intervention plan.
- Presence of serious or terminal comorbidities significantly worsening short- to medium-term prognosis (active cancer, terminal chronic diseases, myocardial infarction within the last 6 months, acute heart failure or NYHA stage ≥ III, etc.).
- History of ketoacidosis.
- Presence of criteria or potential autoimmune insulinopenia (abnormal C-peptide, anti-GAD+ antibodies, pattern of basal and/or glucose-stimulated hypoinsulinemia).
- Cognitive impairment.
- Weight loss exceeding 5 kg in the past 6 months.
- Significant changes in physical activity and/or dietary patterns in the past 6 months.
- History of eating disorders.
- History of substance abuse.
- History of severe psychiatric disorders.
- Pregnancy or intention to become pregnant within the study period.
Key Trial Info
Start Date :
January 11 2026
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 11 2028
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT07207980
Start Date
January 11 2026
End Date
January 11 2028
Last Update
October 6 2025
Active Locations (1)
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1
Parc Sanitari Pere Virgili
Barcelona, Spain