Type 2 diabetes mellitus and metabolic syndrome Nutritional, Metabolic, Endocrine Non-insulin-dependent diabetes mellitus
Conditions
Interventions
The subjects enrolled in the study are randomized and consequently divided into two homogeneous groups to receive the two dietary treatments. Over a period of 21 days they are lodged in two separate h
Sponsors
UPM Un Punto Macrobiotico International Association (Italy)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint is to determine in the two study groups the percentage rate reduction of the following parameters: HbA1c, fasting blood glucose, 2 hours post-lunch blood glucose, HOMA IR, total cholesterol, cholesterol - low density lipoprotein (LDL), triglyceride, BMI, waist and hip circumference. We compare the reduction of these parameters obtained in the two study groups (Ma-Pi 2 diet vs recommended standard diet for diabetic patients according to the Italian Society of Diabetology and Italian Association of Diabetologists guidelines). 1. For HbA1c at time 0 (before dietary intervention on 05/04/2013) and after 21 days of the dietary interventions (on 27/04/2013), and then for the supplementary follow-up at 27/07/2013 and 27/10/2013. 2. For HOMA IR, total cholesterol, cholesterol - low density lipoprotein (LDL), triglyceride, BMI, waist and hip circunference at time 0 (before dietary intervention on 05/04/2013) and after 21 days of the dietary interventions (on 27/04/2013), and then for the supplementary follow-up at 27/07/2013 and 27/10/2013. 3. For fasting and 2 hours post-lunch blood glucose: daily from the 05/07/2013 to the 27/04/2012, and then for the supplementary follow-up at 27/07/2013 and 27/10/2013. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Changes in renal function biochemical parameters (blood urea nitrogen, uric acid) 2. Changes in insulin-like growth factor (IGF1) 3. Changes in markers of inflammation (PCR, WBC, IL-6, TNF-alpha) 4. Changes in gut microbiota composition 5. Changes in body composition Changes in renal function biochemical parameters (blood urea nitrogen, uric acid), changes in insulin-like growth factor (IGF1), changes in markers of inflammation (PCR, WBC, IL-6, TNF-alpha), changes in gut microbiota composition, changes in body composition: at time 0 (before dietary intervention on 05/04/2013) and after 21 days of the dietary interventions (on 27/04/2013). | — |
Countries
Italy
Outcome results
None listed