Remission of Type 2 Diabetes With Lifestyle Intervention

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age20-69
SponsorUniversity of Split, School of Medicine

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

type 2 diabetes diagnosis

incident cases or diagnosed not more than 7 years ago

body mass index of 27-45 kg/m²

Disqualifiers

mobility restriction

use of mobility aids

insulin therapy

HbA1c >12%

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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).

  • 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.

  • 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).

Treatment groups

120 Participants
are divided into 2 treatment groups
Group A: Lifestyle intervention groupExperimental treatment 3 interventions
Group B: Control groupNo intervention 0 interventions

Trial outcomes

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

Time frame
24 months

Secondary outcomes

1

Weight loss

Loss of body weight of ≥15 kg

Time frame
24 months
2

Adverse events

Any adverse event associated with each of the interventions (nutritional, physical activity, psychological)

Time frame
24 months

Other outcomes

1

Additional benefits

change in arterial function measured as pulse wave velocity (PWV)

Time frame
24 months
2

Additional benefits

change in Advanced Glycation End Products measured using AGE Reader mu (DiagnOptics)

Time frame
24 months

Sponsors and contacts

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University of Split, School of Medicine

Lead sponsor

Croatian Science Foundation

Collaborator