About this trial
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 main questions the study seeks to answer are:
* What proportion of participants achieve diabetes remission after 6 months of intervention? * How many participants maintain remission 12 months after completing the program (18 months total)?
Participants will:
* Follow a personalized dietary plan with carbohydrate restriction. * Engage in moderate, accessible physical activity. * Implement strategies to improve circadian rhythm regularity. * Receive psychological counseling and support.
Eligibility criteria
Qualifiers
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%.
Disqualifiers
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.).
Trial design
Treatments tested in this trial
- CREDOenAP intervention