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Not yet recruiting NCT07207980

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

No phase Interventional Type 2 Diabetes Mellitus (T2DM)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: CREDOenAP intervention.
Who it may be relevant to
Registry conditions: Type 2 Diabetes Mellitus (T2DM). Basic parameters: 18 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Spain
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

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

Primary outcome measures

  • Presence of T2DM remission [Time frame: After 6 months of intervention and 12 months after the intervention]
Secondary outcome measures (12)
  • Blood pressure [Time frame: After 6 months of intervention and 12 months after the intervention.]
  • Total cholesterol [Time frame: After 6 months of intervention and 12 months after the intervention]
  • HDL cholesterol [Time frame: After 6 months of intervention and 12 months after the intervention]
  • LDL cholesterol [Time frame: After 6 months of intervention and 12 months after the intervention]
  • Apolipoprotein B100 (ApoB100) [Time frame: After 6 months of intervention and 12 months after the intervention]
  • Triglycerides [Time frame: After 6 months of intervention and 12 months after the intervention]
  • Presence and size of atherosclerotic plaques in carotid arteries [Time frame: After 6 months of intervention and 12 months after the intervention]
  • Weight [Time frame: After 6 months of intervention and 12 months after the intervention]
  • Body Mass Index (BMI) [Time frame: After 6 months of intervention and 12 months after the intervention]
  • Abdominal circumference [Time frame: After 6 months of intervention and 12 months after the intervention]
  • Insulin resistance [Time frame: After 6 months of intervention and 12 months after the intervention]
  • Pancreatic activity [Time frame: After 6 months of intervention and 12 months after the intervention]

Eligibility criteria

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Spain · 1 center
  • Parc Sanitari Pere Virgili — Barcelona

Identifiers

NCT: NCT07207980 · CREDOenAP

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗