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
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 180
- 试验地点
- 1
- 主要终点
- Body Weight
研究概览
简要总结
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:
- the improvement of glycemic variability and metabolic indexes;
- the oxidative status, the endothelial anti-thrombotic activity, the inflammatory status;
- the induction of favorable changes in gut microbiota composition and intestinal permeability.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 30 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Metarecod + Diet
Patients will be given diet and they will take Metarecod 1 sachet twice daily. The diet program will be calculated to achieve a 20% caloric relative decrease from habitual intake, for an average energy deficit of 500 kcal/daily
干预措施: Diet (Other)
Metarecod + Diet
Patients will be given diet and they will take Metarecod 1 sachet twice daily. The diet program will be calculated to achieve a 20% caloric relative decrease from habitual intake, for an average energy deficit of 500 kcal/daily
干预措施: Metarecod (Dietary Supplement)
Low caloric diet
Patients will be given diet program calculated to achieve a 20% caloric relative decrease from habitual intake, for an average energy deficit of 500 kcal/daily with <30% of total calories from fat and at least 15% from proteins.
干预措施: Diet (Other)
结局指标
主要结局
Body Weight
时间窗: 12 months
Difference in body weight expressed in kg after 12 months between randomized arms
次要结局
- Interleukin (IL)-6(12 months)
- C-reactive protein(12 months)
- Waist circumference(12 months)
- Achieving the target weight loss(12 months)
- Glycemic variability(12 months)
- 8-iso-Prostaglandin (PG) F2α(12 months)
- 2,3-dinor-6-keto-PGF1α(12 months)
- Gut microbiota composition(12 months)