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An open-label, randomized, controlled, parallel-group comparative study on the effectiveness of 111-lunchbox dietary method as a dietary management in type 2 diabetic patients

Not Applicable
Conditions
Type 2 diabetes mellitus
Registration Number
JPRN-UMIN000003494
Lead Sponsor
111-lunchbox Study Group
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Complete: follow-up complete
Sex
All
Target Recruitment
60
Inclusion Criteria

Not provided

Exclusion Criteria

1.Complication by stage 3B or more severe diabetic nephropathy, or stage 3 or more severe chronic kidney disease (CKD) not associated with diabetes. 2.Malignant or acute disease. 3.Severe liver disease. 4.Decreased pancreatic function due to chronic pancreatitis, etc. 5.Past history of surgery of the gastrointestinal tract or complication by gastrointestinal disease requiring dietary restriction. 6.Heart failure. 7.Pregnant or lactating women 8.Under steroid treatment 9.Patient judged to have difficulty in performing dietetics on his/her own due to dementia, etc. 10.Other patients judged unsuitable by the attending physician.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
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