Diet With or Without Metarecod® in Obese Subjects With Type 2 Diabetes

Официальное название

Diet With or Without Metarecod® in Obese Subjects With Type 2 Diabetes: Effect on Body Weight, in Vivo Oxidative Stress, Endothelial Function, Low-grade Inflammation and Gut Microbiota

Обзор

Obesity is considered the largest chronic non-communicable disease (globesity) worldwide with a growing trend in the near future. Weight loss programs are strongly recommended in obese patients, especially with type 1 diabetes mellitus (T2DM), although the majority of subjects do not reach or maintain the recommended weight loss target with nutritional intervention alone and one-third of those who achieve a significant weight loss returns to original body weight within one year. Metarecod® (Neopolicaptil Gel Retard) is a substance based medical device consisting of a macromolecule complex derived from high-fiber raw materials, whose mode of action consists in creating an endoluminal gel in the gut that limits glucose and lipids absorption. The primary aim of the present study is to assess whether the combination of Metarecod® and standard diet as compared to diet alone can achieve a superior weight loss over 12 months of treatment. The present study will also compare the effects of the combination of Metarecod® and diet vs diet alone on: 1. the improvement of glycemic variability and metabolic indexes; 2. the oxidative status, the endothelial anti-thrombotic activity, the inflammatory status; 3. the induction of favorable changes in gut microbiota composition and intestinal permeability.

Вмешательства

• Пищевая добавка Metarecod
  Policaptil Gel Retard: Metarecod®. The medical device will be given as 1 sachet twice daily
• Другое Diet
  Diet program will be planned to achieve a ≥8% body weight relative reduction over 12 months and tailored calculating a 20% caloric relative decrease from habitual energy intake, corresponding to an average energy deficit of approximately 500 kcal/daily (approximately a total of 1,200-1,500/daily Kcal for women and 1,500-1,800/daily Kcal for men), with \<30% of total calories from fat (\<10% from satured fats) and at least 15% of total calories from proteins. For carbohydrate intake, low glycemic

Первичные конечные точки

• Body Weight [Срок оценки: 12 months]

Вторичные конечные точки (8)

• Glycemic variability [Срок оценки: 12 months]
• 8-iso-Prostaglandin (PG) F2α [Срок оценки: 12 months]
• 2,3-dinor-6-keto-PGF1α [Срок оценки: 12 months]
• Interleukin (IL)-6 [Срок оценки: 12 months]
• C-reactive protein [Срок оценки: 12 months]
• Waist circumference [Срок оценки: 12 months]
• Achieving the target weight loss [Срок оценки: 12 months]
• Gut microbiota composition [Срок оценки: 12 months]

Критерии участия

Критерии включения

• Signed Informed consent at study entry;
• Age: 30-70 years;
• T2DM diagnosis according to the American Diabetes Association criteria since ≥6 months;
• Stable metabolic control as indicated by levels of glycated hemoglobin (HbA1c) <7.5% on two consecutive measurements before study enrollment;
• Body mass index (BMI) level ≥30 Kg/m2 during the 3 months preceding randomization.

Критерии исключения

• Chronic treatment with corticosteroids and/or chronic treatment with non-steroidal inflammatory drugs, defined as ≥3 times/week with the rationale that these drugs independently impact on the whole inflammatory state;
• Clear indication for dual antiplatelet therapy and/or anticoagulant therapy (full dose);
• Active cancer or cancer in complete remission from less than one year, except for treated early-stage squamous or basal cell skin carcinomas;
• For women with childbearing potential, pregnancy.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Поддерживающая терапия

Центры проведения

Италия · 1 центр

• Fondazione Policlinico Universitario A. Gemelli IRCCS; UOC Diabetologia — Rome

Публикации

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Идентификаторы

NCT: NCT06813170 · 6264

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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