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临床试验/NCT07017127
NCT07017127招募中不适用

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

University of Split, School of Medicine1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2025年5月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
120
试验地点
1
主要终点
Remission of diabetes mellitus type 2

研究概览

简要总结

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

详细描述

Type 2 diabetes (diabetes mellitus type 2, DM2) is a leading clinical and public health problem, with a global prevalence that is rapidly increasing and reaching pandemic proportions. According to the International Diabetes Federation (IDF), 537 million adults between the ages of 20 and 79 in the world have type 2 diabetes (DM2), and it is predicted that this number will increase to 643 million by 2030 and 783 million by 2045. According to the data of the National Register of Persons with DM2 (CroDiab) 337,774 persons with DM2 type 2 were registered in Croatia in 2022.

DM2 increases the risk for cardiovascular diseases, blindness, kidney failure and amputation of the lower limbs, thereby significantly affecting the quality of life of the patients. Additionally, it is well known that people with DM2 often have obstructive sleep apnea (OSA). Therefore, active screening for an OSA diagnosis and its treatment in patients with DM2 is extremely important for the prognosis and successful treatment of DM2, especially since it has been shown that CPAP treatment, along with body weight reduction, is associated with a reduction in HbA1c in morbidly obese patients with severe OSA.

The increased prevalence of DM2 is inextricably linked to the change in lifestyle and the transition to a "western" lifestyle, which implies an abundance of energy-rich foods and reduced physical activity, with a subsequent increase in obesity. Looking at individual components of the diet, it has been shown that sweetened beverages, refined grains and processed meat increase the risk of developing DM2. On the other hand, green leafy vegetables, dairy products, whole grains, nuts, legumes, moderate amounts of alcohol and coffee are associated with a reduction in this risk. Considering not only the individual nutrients in the diet but the entire nutrition pattern, the Mediterranean diet stands out with its numerous protective effects on the health of the organism. Epidemiological and interventional studies have shown the protective effect of the Mediterranean diet in chronic inflammation, insulin resistance, and metabolic syndrome. The Mediterranean diet is best known for its protective cardiovascular effect, which has been shown in a number of studies, meta-analyses and systematic reviews. Among other things, this type of diet supports healthy aging (reaching the age of 70 and over without chronic diseases, such as DM2, kidney disease, respiratory diseases, cancer or Parkinson's disease, and without significant decline in mental and cognitive function).

Losing excess body weight is a key factor in achieving remission of DM2, therefore it is important to look at the evidence of how different dietary patterns can promote weight loss. Comparing low-carbohydrate, low-fat, and Mediterranean diet showed that both the Mediterranean diet and the low-carbohydrate diet were superior in achieving weight loss compared to the low-fat diet. Moreover, these two dietary patterns also showed significant metabolic benefits, such as reduced CRP, reduced fasting glucose and increased insulin sensitivity. In the PREDIMED study, it was shown that a Mediterranean diet supplemented with nuts or extra virgin olive oil reduces the risk of death from stroke by 30%. In addition, there was a significant reduction in the incidence of DM2 in subjects on the Mediterranean diet, independent of weight loss or the subjects' physical activity. Hence, besides weight loss, the quality of nutrition is a valuable factor in the prevention of DM2. The Mediterranean diet is based primarily on unprocessed food of plant origin (vegetables, fruits, legumes, whole grains, nuts). Moderate consumption of fish, seafood and dairy products is encouraged, as well as avoiding red and processed meat. The main source of fat in the Mediterranean diet is extra virgin olive oil. Apart from water as the main drink, wine can be enjoyed in moderation with a meal.

DM2 is considered to be an incurable, chronic and progressive disease. However, several studies recently showed that it is possible to achieve a remission of the disease. It is considered that the remission of DM2 has been achieved if Hba1c is less than 6.5%, without the use of blood glucose-lowering drugs for at least 3 months. Body weight control is the most important aspect of DM2 treatment, with weight reduction leading to reduced morbidity and mortality in these patients. The results of several studies have shown that weight loss of at least 10-15 kg leads to normalization of blood glucose levels in people who were relatively recently diagnosed with DM2. The DIRECT study showed that an intensive and structured weight management program delivered in primary care can result in significant weight loss and diabetes remission among adults with newly diagnosed diabetes. Remission of DM2 was achieved in 46% of subjects who lost an average of 10 kg, after one year. After two years, 36% of subjects were still in remission, with an average of 8 kg lost.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
20 Years 至 69 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

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

排除标准

  • •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
  • •learning disabilities
  • •acute episode of severe depression
  • •current use of antipsychotics
  • •food allergy

研究组 & 干预措施

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)

干预措施: Psychological intervention (Behavioral)

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)

干预措施: Mediterranean diet (Behavioral)

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)

干预措施: Physical activity intervention (Behavioral)

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).

结局指标

主要结局

Remission of diabetes mellitus type 2

时间窗: 24 months

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

次要结局

  • Weight loss(24 months)
  • Adverse events(24 months)

研究者

发起方
University of Split, School of Medicine
申办方类型
Other
责任方
Principal Investigator
主要研究者

Ivana Kolcic

Professor

University of Split, School of Medicine

研究点 (1)

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