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

NCT07207980 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2025-10-06

No results posted yet for this 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.

Conditions

  • Type 2 Diabetes Mellitus (T2DM)

Interventions

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.

Sponsors & Collaborators

  • Parc Sanitari Pere Virgili

    lead OTHER

Principal Investigators

  • Alexandre Ternianov · Parc Sanitari Pere Virgili

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-01-11
Primary Completion
2027-06-30
Completion
2028-01-11

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07207980 on ClinicalTrials.gov