CREDOenAP intervention: Intervention program with intensive lifestyle counseling, added to standard pharmacological treatment subsequently adjusted according to clinical needs and outcomes. The intervention will last 6 months and consists of biweekly in-person and telephone visits. Patients will follow a personalized dietary plan with carbohydrate restriction, based on the recommendations of the American Diabetes Association; engage in moderate and accessible physical activity; implement circadian rhythm regularization; and receive psychological counseling and support.
Study 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 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
Sex
ALL
Min age
18 Years
Max age
80 Years
Healthy volunteers
No
Inclusion Criteria:
1. Signed informed consent.
2. Men and women aged 18-80 years, inclusive.
3. Confirmed diagnosis of T2DM according to recognized diagnostic criteria
4. Most recent recorded hemoglobin A1c (HbA1c) \> 6.5%.
5. Body Mass Index (BMI) greater than 27 kg/m².
Exclusion Criteria:
1. Failure to meet the diagnostic criteria for T2DM in the screening laboratory tests.
2. Being dependent for basic activities of daily living (Barthel score ≤ 90 points).
3. Lack of willingness to cooperate with the follow-up of the lifestyle intervention plan.
4. 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.).
5. History of ketoacidosis.
6. Presence of criteria or potential autoimmune insulinopenia (abnormal C-peptide, anti-GAD+ antibodies, pattern of basal and/or glucose-stimulated hypoinsulinemia).
7. Cognitive impairment.
8. Weight loss exceeding 5 kg in the past 6 months.
9. Significant changes in physical activity and/or dietary patterns in the past 6 months.
10. History of eating disorders.
11. History of substance abuse.
12. History of severe psychiatric disorders.
13. Pregnancy or intention to become pregnant within the study period.
Primary outcome measure(s)
Presence of T2DM remission — After 6 months of intervention and 12 months after the intervention Glycated hemoglobin (HbA1c): T2DM remission will be considered if HbA1c is \< 6.5% after 6 months of intervention and at least 3 months without antidiabetic medication. HbA1c will be determined by blood analysis after a minimum of 8 hours of fasting
Fasting plasma glucose: T2DM remission will be considered if fasting venous plasma glucose is \< 126 mg/dL after 6 months of intervention and at least 3 months without antidiabetic medication. Fasting plasma glucose will be measured by venous blood analysis after a minimum of 8 hours of fasting
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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