RecruitingNot ApplicableNCT07017127

Remission of Type 2 Diabetes With Lifestyle Intervention

Remission of Type 2 Diabetes With Mediterranean Diet, Physical Activity and Psychological Support: a Randomized Clinical Trial

Sponsor

University of Split, School of Medicine

Enrollment

120 participants

Start Date

May 1, 2025

Study Type

INTERVENTIONAL

Conditions

Diabetes Mellitus, Type 2 Obese Diabetics

Summary

The goal of this clinical trial is to achieve diabetes type 2 (DM2) remission using intensive lifestyle intervention. The main questions it aims to answer are: * Does intensive lifestyle intervention (including Mediterranean diet with a caloric deficit, daily physical activity, increase in stress resilience and group support) lead to DM2 remission (HbA1c\<6.5%, without medications) * Can intensive lifestyle intervention (including Mediterranean diet with a caloric deficit, daily physical activity, increase in stress resilience and group support) result to weight loss of \>15 kg * Does intensive lifestyle intervention result in any side effects (secondary outcome) Researchers will compare intensive lifestyle intervention to the usual clinical care (control group). Participants in the experimental group will: * eat Mediterranean diet with a caloric deficit * perform daily physical activity * increase their stress resilience with psychosocial support of the group * enroll weekly in individual and group counseling and workshops for 6 months, following with 1.5 years of follow-up

Eligibility

Min Age: 20 YearsMax Age: 69 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether an intensive lifestyle intervention — focused on diet and weight loss — can lead to full remission (reversal) of type 2 diabetes in people who were recently diagnosed or have had the condition for fewer than 7 years. **You may be eligible if...** - You have been diagnosed with type 2 diabetes within the past 7 years - Your BMI is between 27 and 45 kg/m² (overweight to obese range) - You are managing diabetes without insulin - Your HbA1c (blood sugar control measure) is below 12% **You may NOT be eligible if...** - You require insulin therapy - You have had a heart attack or stroke in the past year - You have severe kidney disease - You are pregnant or planning to become pregnant - You have mobility restrictions - You have active cancer, severe depression, or an eating disorder - You have lost more than 5 kg in the last 6 months Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BEHAVIORALMediterranean diet

Exclusion of highly processed food products and beverages, introduction of a diet according to the modern pyramid of the Mediterranean diet (44). Subjects will be recommended to reduce as much as possible the use of plastic food and drinks containers. The nutritionist will create personalized nutritional recommendation, with a moderate reduction in caloric intake (quantified by calculating the basal metabolism and ideal body mass of each subject, and the whole day's energy consumption). The goal of this part of the intervention is to achieve a weight loss of at least 0.5 kg every week, by reducing caloric intake by 300-500 kcal. The nutritionist will create sample menus throughout the day, for 30 days, to make it easier for subjects to follow this part of the intervention. In addition, each subject of the experimental group will receive a total of six liters of extra virgin olive oil (one liter per month for 6 months).

BEHAVIORALPhysical activity intervention

Participants will be involved in aerobic activities expertly guided by kinesiologist (Nordic walking) every day for 45-60 minutes, spent in nature or indoors in case of unfavorable weather. Along with Nordic walking, participants will be involved in organized muscle strength and endurance exercises twice a week for 60 minutes with the use of external loads (elastic bands, small weights), and mobility, balance and coordination will also be developed. All training programs will be conducted by trained kinesiologists who will instruct, monitor and correct participants in order to perform the exercises correctly and get the maximum effect on the targeted motor skills. Nordic walking, resistance exercise, and a combination of aerobic activity and resistance exercise have been shown to be effective in improving cardiometabolic parameters, physical fitness, and quality of life in people with DM2.

BEHAVIORALPsychological intervention

Support group meetings discussing mental health topics and encouraging change through the adoption of healthy lifestyle habits. Psycho-educational component, stimulating group environment for sharing personal experiences, motivation and becoming aware of emotions and resistance. The specific topics of individual group meetings will be: stress and stress management, relaxation techniques (breathing techniques, autogenic training, progressive muscle relaxation techniques and guided fantasies), emotion management (recognition of negative beliefs and thought patterns, awareness and management of emotional reactions), interpersonal skills in the function of self-care (awareness and communication of one's own needs through assertive communication techniques), self-care through the adoption of healthy habits (motivation, adoption of habits and planning), conscious eating and the alike, creating a list of SMART goals (45).