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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
120
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.
Parc Sanitari Pere Virgili
Barcelona, Spain
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
Time frame: After 6 months of intervention and 12 months after the intervention
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.
Time frame: After 6 months of intervention and 12 months after the intervention.
Total cholesterol
Measured in mg/dL via blood analysis.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: After 6 months of intervention and 12 months after the intervention
Triglycerides
Measured in mg/dL via blood analysis
Time frame: 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.
Time frame: After 6 months of intervention and 12 months after the intervention
Weight
Measured in kilograms (kg)
Time frame: 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.
Time frame: 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)
Time frame: 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
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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)
Time frame: 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)
Time frame: 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
Time frame: After 6 months of intervention and 12 months after the intervention
Smoking habits
Measured by a study-specific questionnaire
Time frame: 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
Time frame: After 6 months of intervention and 12 months after the intervention
Circadian habits
Measured by a study-specific questionnaire
Time frame: 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
Time frame: 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
Time frame: 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)
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
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)
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
Annual contacts with the healthcare system including Primary Care (physicians and nursing), Specialized Care, and Emergency Care
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
Emergency visits related to diabetes during the intervention period
Time frame: During each follow-up telephone visit throughout the intervention, after 6 months of intervention and 12 months after the intervention
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