NCT07207980Not yet recruiting
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)
Source: ClinicalTrials.gov · Last updated 6 Oct 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 120 (estimated)
- First submitted
- 16 Sept 2025
- Start date
- 11 Jan 2026
- Primary completion date
- 30 Jun 2027
- Lead sponsor
- Parc Sanitari Pere Virgili
- Diseases
- Type 2 diabetes
- NCT number
- NCT07207980
What you commit to
- Study type: Interventional
- Planned participants: 120
- From 11 Jan 2026 to the primary completion date, 30 Jun 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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.
- Cognitive impairment.
- History of eating disorders.
- History of substance abuse.
- History of severe psychiatric disorders.
Lab values
- Failure to meet the diagnostic criteria for T2DM in the screening laboratory tests.
- Presence of criteria or potential autoimmune insulinopenia (abnormal C-peptide, anti-GAD+ antibodies, pattern of basal and/or glucose-stimulated hypoinsulinemia).
Other
- 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.
- Weight loss exceeding 5 kg in the past 6 months.
- Significant changes in physical activity and/or dietary patterns in the past 6 months.
- Pregnancy or intention to become pregnant within the study period.
Who the study is looking for
- 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.
Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Parc Sanitari Pere Virgili Coordinator of this site? Confirm its status | Barcelona | Spain | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.