Lifestyle Intervention for Type 2 Diabetes in Primary Care (CREDOenAP)

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorParc Sanitari Pere Virgili

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

Treatment groups

120 Participants
are divided into 2 treatment groups

Sponsors and collaborators