Type 2 Diabetes Mellitus (T2DM)
Conditions
Keywords
Type 2 Diabetes Mellitus (T2DM), Diabetes Remission, Lifestyle Intervention, Primary Care
Brief 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. 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
BEHAVIORALCREDOenAP 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; and receive psychological counseling and support.
Sponsors
Parc Sanitari Pere Virgili
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Signed informed consent. 2. Men and women aged 18-80 years, inclusive. 3. Confirmed diagnosis of T2DM according to recognized diagnostic criteria 4. Most recent recorded hemoglobin A1c (HbA1c) \> 6.5%. 5. Body Mass Index (BMI) greater than 27 kg/m².
Exclusion criteria
1. Failure to meet the diagnostic criteria for T2DM in the screening laboratory tests. 2. Being dependent for basic activities of daily living (Barthel score ≤ 90 points). 3. Lack of willingness to cooperate with the follow-up of the lifestyle intervention plan. 4. 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.). 5. History of ketoacidosis. 6. Presence of criteria or potential autoimmune insulinopenia (abnormal C-peptide, anti-GAD+ antibodies, pattern of basal and/or glucose-stimulated hypoinsulinemia). 7. Cognitive impairment. 8. Weight loss exceeding 5 kg in the past 6 months. 9. Significant changes in physical activity and/or dietary patterns in the past 6 months. 10. History of eating disorders. 11. History of substance abuse. 12. History of severe psychiatric disorders. 13. Pregnancy or intention to become pregnant within the study period.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Presence of T2DM remission | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Blood pressure | After 6 months of intervention and 12 months after the intervention. | 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. |
| Total cholesterol | After 6 months of intervention and 12 months after the intervention | Measured in mg/dL via blood analysis. |
| HDL cholesterol | After 6 months of intervention and 12 months after the intervention | High-density lipoprotein (HDL) cholesterol measured in mg/dL via blood analysis. |
| LDL cholesterol | After 6 months of intervention and 12 months after the intervention | Low-density lipoprotein (LDL) cholesterol measured in mg/dL via blood analysis. |
| Apolipoprotein B100 (ApoB100) | After 6 months of intervention and 12 months after the intervention | A protein involved in cholesterol transport and relevant for evaluating elevated cholesterol causes, measured in mg/dL via blood analysis. |
| Triglycerides | After 6 months of intervention and 12 months after the intervention | Measured in mg/dL via blood analysis |
| Presence and size of atherosclerotic plaques in carotid arteries | After 6 months of intervention and 12 months after the intervention | 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. |
| Weight | After 6 months of intervention and 12 months after the intervention | Measured in kilograms (kg) |
| Abdominal circumference | After 6 months of intervention and 12 months after the intervention | Measured at the midpoint between the lowest rib and the iliac crest during maximal inspiration and expiration, in centimeters (cm) |
| Insulin resistance | After 6 months of intervention and 12 months after the intervention | 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 |
| Pancreatic activity | After 6 months of intervention and 12 months after the intervention | 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). |
| Fasting insulin | After 6 months of intervention and 12 months after the intervention | 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. |
| Metabolic Syndrome Diagnosis | After 6 months of intervention and 12 months after the intervention | 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. |
| Body Mass Index (BMI) | After 6 months of intervention and 12 months after the intervention | Calculated from weight and height using the formula: BMI = weight (kg) / \[height (m)\]². |
| NAFLD Fibrosis Score | After 6 months of intervention and 12 months after the intervention | 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) |
| Physical activity | After 6 months of intervention and 12 months after the intervention | Physical activity will be assessed using the International Physical Activity Questionnaire (IPAQ) |
| Nutritional and energy composition: | After 6 months of intervention and 12 months after the intervention | The 24-hour dietary recall questionnaire will be administered at each biweekly visit |
| Smoking habits | After 6 months of intervention and 12 months after the intervention | Measured by a study-specific questionnaire |
| Alcohol consumption | After 6 months of intervention and 12 months after the intervention | Alcohol intake will be quantified using a questionnaire combined with a standardized alcohol unit conversion calculator |
| Circadian habits | After 6 months of intervention and 12 months after the intervention | Measured by a study-specific questionnaire |
| Health status | After 6 months of intervention and 12 months after the intervention | SF-36: This is a generic scale that provides a health status profile and is applicable both to patients and to the general population |
| Medication consumption | After 6 months of intervention and 12 months after the intervention | 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 |
| Number of hypoglycemia episodes | During each follow-up telephone visit throughout the intervention, after 6 months of intervention and 12 months after the intervention | Episodes of hypoglycemia detected by patients through capillary blood glucose levels and/or recorded in eCAP during the intervention (plasma glucose \<60 mg/dl) |
| Number of symptomatic hyperglycemia episodes | During each follow-up telephone visit throughout the intervention, after 6 months of intervention and 12 months after the intervention | 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) |
| Total number of healthcare visits | During each follow-up telephone visit throughout the intervention, after 6 months of intervention and 12 months after the intervention | Annual contacts with the healthcare system including Primary Care (physicians and nursing), Specialized Care, and Emergency Care |
| Number of diabetes-related emergency episodes | During each follow-up telephone visit throughout the intervention, after 6 months of intervention and 12 months after the intervention | Emergency visits related to diabetes during the intervention period |
| NAFLD Liver Fat Score | After 6 months of intervention and 12 months after the intervention | 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 |
Countries
Spain
Contacts
Primary ContactAlexandre Ternianov Principal investigator
Outcome results
None listed