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Clinical Trials/ISRCTN10467793
ISRCTN10467793
Completed
Not Applicable

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 sites58 target enrollmentSeptember 27, 2013
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Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Not specified
Sponsor
PM Un Punto Macrobiotico International Association (Italy)
Enrollment
58
Status
Completed
Last Updated
11 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
September 27, 2013
End Date
TBD
Last Updated
11 years ago
Study Type
Interventional
Sex
All

Investigators

Sponsor
PM Un Punto Macrobiotico International Association (Italy)

Eligibility 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

  • •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

Outcomes

Primary Outcomes

Not specified

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