Remission of Type 2 Diabetes With Lifestyle Intervention

NCT07017127 | Recruiting

• 4 other identifiers: HRZZ-IP-2024-05-37572181-198-03-04-24-01172181-147/01-06/LJ.Z.-24-022181-149-18-24-002
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

diabetes remission; Mediterranean diet; physical activity; stress; weight loss; healthy lifestyle

Outcome Measures

Primary Outcomes (1)

• Remission of diabetes mellitus type 2

  Change of HbA1c to \<6.5%, without the use of blood glucose lowering therapy for the past 3 months

  24 months

Secondary Outcomes (2)

• Weight loss

  24 months

• Adverse events

  24 months

Other Outcomes (2)

• Additional benefits

  24 months

• Additional benefits

  24 months

Study Arms (2)

Lifestyle intervention group

EXPERIMENTAL

The intervention will consist of the following elements: 1. Mediterranean diet - personalized nutritional recommendation based on the modern pyramid of the Mediterranean diet (44), additionally adjusted based on the current nutritional status of the subjects (tested through anthropometric and body composition parameters), and considering the level of physical activity during free time and professional requirements 2. Physical activity - emphasis on reducing sedentary behavior and including a daily regime of aerobic exercises, and exercises for muscle strength and endurance 2 times a week 3. Psychological support and intervention - group and individual counselling of subjects on effective ways of coping with stress 4. Positive and supportive interpersonal relationships - implementation of the intervention in small groups, which will be formed primarily as support groups (12 subjects per group) - weekly meetings, counselling and workshops, group exercise (walking)

Behavioral: Mediterranean diet; Behavioral: Physical activity intervention; Behavioral: Psychological intervention

Control group

NO INTERVENTION

Subjects in the control group will receive a short brochure that will be created for the purposes of this project on the importance of healthy lifestyle habits in people diagnosed with DM2, as well as advice and recommendations from a specialists for practicing healthy eating and physical activity. Furthermore, the subjects of the control group will receive regular clinical care within the framework of the health care system. At the same time intervals as the subjects of the experimental group, these subjects will be invited for a clinical examination, carrying out all measurements and tests, filling out questionnaires and providing biological samples (fasting blood and urine).

Interventions

Mediterranean diet BEHAVIORAL

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).

Lifestyle intervention group

Physical activity intervention BEHAVIORAL

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.

Lifestyle intervention group

Psychological intervention BEHAVIORAL

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).

Lifestyle intervention group

Eligibility Criteria

• Age: 20 Years - 69 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• type 2 diabetes diagnosis
• incident cases or diagnosed not more than 7 years ago
• body mass index of 27-45 kg/m²

You may not qualify if:

• mobility restriction
• use of mobility aids
• insulin therapy
• HbA1c \>12%
• TSH \>10 mU/L
• heart failure (NYHA III, NYHA IV)
• use of obesity pharmacotherapy (orlistat, GLP-1 receptor agonists, GLP-1/GIP dual agonists) for less than 6 months
• weight loss greater than 5 kg in the last 6 months
• chronic kidney disease and estimated glomerular filtration rate \<30 ml/min/1.73 m2
• active treatment of proliferative diabetic retinopathy with anti-VEGF
• heart attack or stroke in the past 1 year
• active malignant disease diagnosed in the past 1 year
• eating disorders
• pregnancy or pregnancy planning
• substance abuse

Sponsors & Collaborators

• University of Split, School of Medicine: lead
• Croatian Science Foundation: collaborator

Study Sites (1)

University of Split School of Medicine

Split, 21000, Croatia

RECRUITING

Related Publications (30)

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MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Motor Activity; Weight Loss

Interventions

Diet, Mediterranean; Psychosocial Intervention

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Behavior; Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diet, Plant-Based; Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Ivana Kolčić, Prof, MD, PhD

  University of Split, School of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ivana Kolčić, Professor

CONTACT

+38515762263; ikolcic@mefst.hr

Lana Barać, PhD

CONTACT

lana.barac@mefst.hr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 8, 2025
• First Posted: June 12, 2025
• Study Start: May 1, 2025
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): December 17, 2027
• Last Updated: June 12, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

CR (1)