Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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:
Participants will:
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Control group | No Intervention | They will receive the standard clinical treatment for diabetes |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | After 6 months of intervention and 12 months after the intervention. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Alexandre Ternianov Principal investigator | Contact | +34 932 21 37 85 | aternianov@perevirgili.cat |
| Name | Affiliation | Role |
|---|---|---|
| Alexandre Ternianov | Parc Sanitari Pere Virgili | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Parc Sanitari Pere Virgili | Barcelona | Spain |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Sep 4, 2025 | Sep 16, 2025 | Prot_000.pdf |
Not provided
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Total cholesterol | Measured in mg/dL via blood analysis. | 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. | 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. | 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. | After 6 months of intervention and 12 months after the intervention |
| Triglycerides | Measured in mg/dL via blood analysis | 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. | After 6 months of intervention and 12 months after the intervention |
| Weight | Measured in kilograms (kg) | 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. | 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) | 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 | 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). | 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. | 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:
| 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 | 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) | 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) | 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 | After 6 months of intervention and 12 months after the intervention |
| Smoking habits | Measured by a study-specific questionnaire | 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 | After 6 months of intervention and 12 months after the intervention |
| Circadian habits | Measured by a study-specific questionnaire | 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 | 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 | 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) | 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) | 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 | 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 | During each follow-up telephone visit throughout the intervention, after 6 months of intervention and 12 months after the intervention |
| D004700 | Endocrine System Diseases |