A randomised controlled trial to assess the short-term effect of the macrobiotic diet Ma-Pi 2 in patients with type 2 diabetes and metabolic syndrome

PM Un Punto Macrobiotico International Association (Italy)0 个研究点目标入组 58 人开始时间: 2013年9月27日最近更新: 2015年1月13日

试验速览

暂无简介。

•1. Subjects affected by type 2 diabetes and metabolic syndrome
•2. Subjects of both genders, aged 40 to 80 years
•3. Subjects who able to sign the informed consent and to follow the study requests
•4. Subjects with body mass index (BMI) >25 kg/m2 but <45 kg/m2
•5. DM treated with diet only or oral hypoglycemic agents [sulfonylureas (SU), metformin (MF)] and / with GLP-1 (injecting or orally) alone and/or in combination but not insulin therapy

•1. Patients affected by type 1 diabetes mellitus or type 2 diabetes on insulin therapy
•2. Patients with serious underlying medical conditions such as cancer, severe infections, severe psychiatric disorders
•3. Patients who have done other clinical trials in the prior three months of this study
•4. Known or suspected hypersensitivity to one or more ingredients of the diets
•5. Patients undergoing cortico-therapy or other drugs that may interfere with the metabolism of carbohydrates
•6. Patients undergoing antibiotic therapy

发起方

PM Un Punto Macrobiotico International Association (Italy)