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

NCT07207980 | Not Yet Recruiting

• 1 other identifier: CREDOenAP
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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)

Keywords

Type 2 Diabetes Mellitus (T2DM); Diabetes Remission; Lifestyle Intervention; Primary Care

Outcome Measures

Primary Outcomes (1)

• Presence of T2DM remission

  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

  After 6 months of intervention and 12 months after the intervention

Secondary Outcomes (27)

• Blood pressure

  After 6 months of intervention and 12 months after the intervention.

• Total cholesterol

  After 6 months of intervention and 12 months after the intervention

• HDL cholesterol

  After 6 months of intervention and 12 months after the intervention

• LDL cholesterol

  After 6 months of intervention and 12 months after the intervention

• Apolipoprotein B100 (ApoB100)

  After 6 months of intervention and 12 months after the intervention

Study Arms (2)

Intervention group

EXPERIMENTAL

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.

Behavioral: CREDOenAP intervention

Control group

NO INTERVENTION

They will receive the standard clinical treatment for diabetes

Interventions

CREDOenAP intervention BEHAVIORAL

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.

Intervention group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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%.
• Body Mass Index (BMI) greater than 27 kg/m².

You may not qualify if:

• 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.).
• History of ketoacidosis.
• Presence of criteria or potential autoimmune insulinopenia (abnormal C-peptide, anti-GAD+ antibodies, pattern of basal and/or glucose-stimulated hypoinsulinemia).
• Cognitive impairment.
• Weight loss exceeding 5 kg in the past 6 months.
• Significant changes in physical activity and/or dietary patterns in the past 6 months.
• History of eating disorders.
• History of substance abuse.
• History of severe psychiatric disorders.
• Pregnancy or intention to become pregnant within the study period.

Sponsors & Collaborators

• Parc Sanitari Pere Virgili: lead

Study Sites (1)

Parc Sanitari Pere Virgili

Barcelona, Spain

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Alexandre Ternianov

  Parc Sanitari Pere Virgili

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alexandre Ternianov Principal investigator

CONTACT

+34 932 21 37 85; aternianov@perevirgili.cat

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 16, 2025
• First Posted: October 6, 2025
• Study Start: January 11, 2026
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): January 11, 2028
• Last Updated: October 6, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)