Remission of Type 2 Diabetes With Lifestyle Intervention

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

Conditions

• Diabetes Mellitus Type 2
• Obese Diabetics

Interventions

BEHAVIORAL

Mediterranean 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).

BEHAVIORAL

Physical 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.

BEHAVIORAL

Psychological 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).

Sponsors & Collaborators

• Croatian Science Foundation

  collaborator OTHER_GOV

• University of Split, School of Medicine

  lead OTHER

Principal Investigators

• Ivana Kolčić, Prof, MD, PhD · University of Split, School of Medicine

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

20 Years

Max Age

69 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-05-01

Primary Completion

2027-06-01

Completion

2027-12-17

Countries

• Croatia

Study Locations