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

Parc Sanitari Pere Virgili

Status: Not yet enrolling

Conditions: Type 2 Diabetes Mellitus (T2DM)

Treatments: Behavioral: CREDOenAP intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT07207980

CREDOenAP

Details and patient eligibility

About

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.

Enrollment: 120 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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120 participants in 2 patient groups

Intervention group

Experimental group

Description:

The program consists of biweekly in-person and telephone visits, focused on implementing a personalized dietary plan with carbohydrate restriction, based on the American Diabetes Association recommendations; moderate and accessible physical activity; circadian rhythm regularization; and psychological counseling and support.

Treatment:

Behavioral: CREDOenAP intervention

Control group

No Intervention group

Description:

They will receive the standard clinical treatment for diabetes