NCT07207980

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

Lifestyle Intervention Clinical Trial for the Remission of Type 2 Diabetes Mellitus in Primary Care (CREDOenAP)

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Parc Sanitari Pere Virgili · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Type 2 Diabetes Mellitus (T2DM)

Interventions

Type	Name	Description
BEHAVIORAL	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.

Timeline

• Start date: 2026-01-11
• Primary completion: 2027-06-30
• Completion: 2028-01-11
• First posted: 2025-10-06
• Last updated: 2025-10-06

Locations

1 site across 1 country: Spain