Type 2 Diabetes Mellitus (T2DM)CREDOenAPNCT07207980
Lifestyle Intervention for Type 2 Diabetes in Primary Care (CREDOenAP)
A study testing CREDOenAP intervention in people with Type 2 Diabetes Mellitus (T2DM), run by Parc Sanitari Pere Virgili at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Type 2 Diabetes Mellitus (T2DM)
- What is being tested?
- CREDOenAP intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteSpain
- Study dates
- 11 Jan 2026to 11 Jan 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site
Parc Sanitari Pere Virgili
Barcelona
Neus Carrilero Primary and Community Care Research Coordinator, + 34 659 77 29 79, ncarrilero@perevirgili.cat
Aida Veras Primary and Community Care Researcher, averas@perevirgili.cat
About this study
Official title: Lifestyle Intervention Clinical Trial for the Remission of Type 2 Diabetes Mellitus in Primary Care (CREDOenAP)
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)
- Being tested
- CREDOenAP intervention
- Keywords
- Type 2 Diabetes Mellitus (T2DM), Diabetes Remission, Lifestyle Intervention, Primary Care
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CREDOenAP interventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: CREDOenAP intervention |
| Control group | No intervention | They will receive the standard clinical treatment for diabetes |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: After 6 months of intervention and 12 months after the intervention
Secondary outcomes (27)
Blood pressure
Blood pressure will be measured three times after the participant has been seated at rest for 10 minutes with uncrossed legs. The mean of the last two measurements will be used for statistical analysis. Systolic and diastolic blood pressure will be reported in mmHg using a brachial cuff sphygmomanometer.
Measured: After 6 months of intervention and 12 months after the intervention.
Total cholesterol
Measured in mg/dL via blood analysis.
Measured: After 6 months of intervention and 12 months after the intervention
HDL cholesterol
High-density lipoprotein (HDL) cholesterol measured in mg/dL via blood analysis.
Measured: After 6 months of intervention and 12 months after the intervention
LDL cholesterol
Low-density lipoprotein (LDL) cholesterol measured in mg/dL via blood analysis.
Measured: After 6 months of intervention and 12 months after the intervention
Apolipoprotein B100 (ApoB100)
A protein involved in cholesterol transport and relevant for evaluating elevated cholesterol causes, measured in mg/dL via blood analysis.
Measured: After 6 months of intervention and 12 months after the intervention
Triglycerides
Measured in mg/dL via blood analysis
Measured: After 6 months of intervention and 12 months after the intervention
Presence and size of atherosclerotic plaques in carotid arteries
Assessed via Doppler ultrasound of the supraaortic trunks. If plaques are present, the total plaque area will be measured in cm², and changes in plaque area will be tracked throughout the study.
Measured: After 6 months of intervention and 12 months after the intervention
Weight
Measured in kilograms (kg)
Measured: After 6 months of intervention and 12 months after the intervention
Body Mass Index (BMI)
Calculated from weight and height using the formula: BMI = weight (kg) / [height (m)]².
Measured: After 6 months of intervention and 12 months after the intervention
Abdominal circumference
Measured at the midpoint between the lowest rib and the iliac crest during maximal inspiration and expiration, in centimeters (cm)
Measured: After 6 months of intervention and 12 months after the intervention
Insulin resistance
Evaluated using the HOMA-IR index (Homeostasis Model Assessment of Insulin Resistance), which estimates insulin resistance and beta-cell function. Determined via blood analysis after a minimum 8-hour fast. Values above 2.5 may indicate T2D. Calculated as: [fasting insulin (μU/mL) x glucemia basal (mmol/L)] / 22.5 = [fasting insulin (μU/mL) x (Glucemia basal (mg/dL) x 0,0555)] / 22.5
Measured: After 6 months of intervention and 12 months after the intervention
Pancreatic activity
Assessed using the HOMA-B index, which evaluates the function and activity of pancreatic beta cells. HOMA-B, together with HOMA-IR, helps in the diagnosis of T2D. Values between 167 and 175 are considered normal and not indicative of T2D. Values below this range suggest impaired beta-cell function, resulting in insufficient insulin production (insulinopenia).
Measured: After 6 months of intervention and 12 months after the intervention
Fasting insulin
Measures the amount of insulin in a blood sample. Insulin is a hormone produced by the pancreas. Normal values range between 5-25 U/mL. It will be measured via blood analysis after a minimum 8-hour fast.
Measured: After 6 months of intervention and 12 months after the intervention
Metabolic Syndrome Diagnosis
Metabolic Syndrome Diagnosis is established if at least three of the following five criteria are present:
- Abdominal circumference: Men of European descent > 94 cm; Women of European descent > 80 cm. For other ethnicities, cut-off points are defined according to the International Diabetes Federation (IDF). (López De La Torre et al., 2010)
- Fasting glucose: > 100 mg/dL or receiving pharmacological treatment for hyperglycemia.
- Triglycerides: > 150 mg/dL or receiving lipid-lowering therapy.
- HDL cholesterol: < 40 mg/dL in men; < 50 mg/dL in women, or receiving lipid-lowering therapy.
- Blood pressure: Systolic > 130 mmHg or Diastolic > 85 mmHg, or receiving antihypertensive treatment.
Measured: After 6 months of intervention and 12 months after the intervention
NAFLD Liver Fat Score
Non-alcoholic fatty liver disease (NAFLD) is a condition characterized by excessive fat accumulation in the liver. Its severity can vary according to the score: < -1.455 low risk, -1.455 to 0.675 intermediate risk, > 0.675 high risk (Angulo et al., 2007; Kotronen et al., 2009).
The calculation is determined using the following formula:
-2.89 + 1.18 × Metabolic Syndrome (Yes = 1 / No = 0) + 0.45 × T2DM (Yes = 2 / No = 0) + 0.15 × Fasting Insulin (mU/L) + 0.04 × Fasting Serum AST (U/L) - 0.94 × AST/ALT ratio
Measured: After 6 months of intervention and 12 months after the intervention
NAFLD Fibrosis Score
The identification and quantification of fibrosis are clinically relevant since fibrosis is associated with an unfavorable clinical prognosis. An NFS > 0.676 indicates the presence of advanced fibrosis (Angulo et al., 2007; Kotronen et al., 2009). The calculation is determined using the following formula:
-1.675 + 0.037 × Age (years) + 0.094 × BMI (kg/m²) + 1.13 × IFG/diabetes (Yes = 1 / No = 0) + 0.99 × AST/ALT ratio - 0.013 × Platelets (×10⁹/L) - 0.66 × Albumin (g/dL)
Measured: After 6 months of intervention and 12 months after the intervention
Physical activity
Physical activity will be assessed using the International Physical Activity Questionnaire (IPAQ)
Measured: After 6 months of intervention and 12 months after the intervention
Nutritional and energy composition:
The 24-hour dietary recall questionnaire will be administered at each biweekly visit
Measured: After 6 months of intervention and 12 months after the intervention
Smoking habits
Measured by a study-specific questionnaire
Measured: After 6 months of intervention and 12 months after the intervention
Alcohol consumption
Alcohol intake will be quantified using a questionnaire combined with a standardized alcohol unit conversion calculator
Measured: After 6 months of intervention and 12 months after the intervention
Circadian habits
Measured by a study-specific questionnaire
Measured: After 6 months of intervention and 12 months after the intervention
Health status
SF-36: This is a generic scale that provides a health status profile and is applicable both to patients and to the general population
Measured: After 6 months of intervention and 12 months after the intervention
Medication consumption
Defined Daily Dose (DDD) by active substance: DDDs of the active substances consumed will be classified according to ATC7. Each ATC classification has a defined daily dose based on international standards, which determine the recommended maximum daily amount for the approved indication of the active substance
Measured: After 6 months of intervention and 12 months after the intervention
Number of hypoglycemia episodes
Episodes of hypoglycemia detected by patients through capillary blood glucose levels and/or recorded in eCAP during the intervention (plasma glucose <60 mg/dl)
Measured: During each follow-up telephone visit throughout the intervention, after 6 months of intervention and 12 months after the intervention
Number of symptomatic hyperglycemia episodes
Episodes of hyperglycemia recorded in eCAP during the intervention (plasma glucose >350 mg/dl accompanied by compatible symptoms such as general malaise, nausea, asthenia, among others)
Measured: During each follow-up telephone visit throughout the intervention, after 6 months of intervention and 12 months after the intervention
Total number of healthcare visits
Annual contacts with the healthcare system including Primary Care (physicians and nursing), Specialized Care, and Emergency Care
Measured: During each follow-up telephone visit throughout the intervention, after 6 months of intervention and 12 months after the intervention
Number of diabetes-related emergency episodes
Emergency visits related to diabetes during the intervention period
Measured: During each follow-up telephone visit throughout the intervention, after 6 months of intervention and 12 months after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2025
- Study start11 Jan 2026 (estimated)
- Primary completion30 Jun 2027 (estimated)
- Study completion11 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 Diabetes Mellitus (T2DM)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Parc Sanitari Pere Virgili
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alexandre Ternianov, Principal investigator, Parc Sanitari Pere Virgili
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07207980
- Sponsor's protocol ID
- CREDOenAP
- Acronym
- CREDOenAP
- Status last verified
- Sep 2025
- First submitted
- 16 Sep 2025
- Last updated
- 6 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lifestyle Intervention Clinical Trial for the Remission of Type 2 Diabetes Mellitus in Primary Care (CREDOenAP)
- ClinicalTrials.gov ID
- NCT07207980
- Acronym / sponsor ID
- CREDOenAP / CREDOenAP
- Conditions
- Type 2 Diabetes Mellitus (T2DM)
- Keywords
- Type 2 Diabetes Mellitus (T2DM), Diabetes Remission, Lifestyle Intervention, Primary Care
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Parc Sanitari Pere VirgiliUniversity, hospital or other
- Study start
- 11 Jan 2026 (estimated)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 11 Jan 2028 (estimated)
- First posted
- 6 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Behavioral: CREDOenAP interventionThe 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. |
| Control group | No intervention | –They will receive the standard clinical treatment for diabetes |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CREDOenAP interventionIntervention 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. | Behavioural | Intervention group |
Primary outcome
Presence of T2DM remission
Time frame: After 6 months of intervention and 12 months after the intervention
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
27 secondary outcomes
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
Fasting insulin
Time frame: After 6 months of intervention and 12 months after the intervention
Metabolic Syndrome Diagnosis
Time frame: After 6 months of intervention and 12 months after the intervention
NAFLD Liver Fat Score
Time frame: After 6 months of intervention and 12 months after the intervention
NAFLD Fibrosis Score
Time frame: After 6 months of intervention and 12 months after the intervention
Physical activity
Time frame: After 6 months of intervention and 12 months after the intervention
Nutritional and energy composition:
Time frame: After 6 months of intervention and 12 months after the intervention
Smoking habits
Time frame: After 6 months of intervention and 12 months after the intervention
Alcohol consumption
Time frame: After 6 months of intervention and 12 months after the intervention
Circadian habits
Time frame: After 6 months of intervention and 12 months after the intervention
Health status
Time frame: After 6 months of intervention and 12 months after the intervention
Medication consumption
Time frame: After 6 months of intervention and 12 months after the intervention
Number of hypoglycemia episodes
Time frame: During each follow-up telephone visit throughout the intervention, after 6 months of intervention and 12 months after the intervention
Number of symptomatic hyperglycemia episodes
Time frame: During each follow-up telephone visit throughout the intervention, after 6 months of intervention and 12 months after the intervention
Total number of healthcare visits
Time frame: During each follow-up telephone visit throughout the intervention, after 6 months of intervention and 12 months after the intervention
Number of diabetes-related emergency episodes
Time frame: During each follow-up telephone visit throughout the intervention, after 6 months of intervention and 12 months after the intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Alexandre Ternianov principal investigator
Parc Sanitari Pere Virgili
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CREDOenAP intervention in people with Type 2 Diabetes Mellitus (T2DM), run by Parc Sanitari Pere Virgili at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 6 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alexandre Ternianov Principal investigator (+34 932 21 37 85, aternianov@perevirgili.cat), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Presence of T2DM remission (time frame: After 6 months of intervention and 12 months after the intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2025.