MADIAB study: To assess the effect of the Ma-Pi 2 MAcrobiotic DIet on the improvement of metabolic control in patients with type 2 diABetes and metabolic syndrome

Completed

• Conditions: Type 2 diabetes mellitus and metabolic syndrome; Nutritional, Metabolic, Endocrine; Non-insulin-dependent diabetes mellitus

• Registration Number: ISRCTN10467793
• Lead Sponsor: PM Un Punto Macrobiotico International Association (Italy)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-09-27
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 58

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified