Status:
UNKNOWN
Multiple Grain in Type 2 Diabetes
Lead Sponsor:
National Cheng-Kung University Hospital
Conditions:
Diabetes Mellitus
Eligibility:
All Genders
25-75 years
Phase:
PHASE4
Brief Summary
We aim to investigate the beneficial effect of adding grain fiber to daily rice meal in type 2 diabetic patients. We anticipate this intervention will improve glycemia and lipid profile in these patie...
Detailed Description
Resistance of insulin-mediated glucose transport is a fundamental early defect in the pathogenesis of type 2 diabetes mellitus (DM). It has been found that high fiber concentration in meal is frequent...
Eligibility Criteria
Inclusion
- Mentally competent adults of either sex with age 30-75 years old
- Patients have type 2 diabetes mellitus diagnosed after 25 years of age
- Patients have been in inadequate but stable glycemic control by diet. Inadequate glycemic control isdefined as: HbA1c 7.1-11.0%
- Patients have signed the written informed consent.
Exclusion
- Patients with type 1 diabetes mellitus
- Patients with alcohol, drugs or medications abuse considered by the investigator
- Patients with impaired liver function (AST, ALT\>2.5× upper limit of normal)
- Patients with impaired kidney function (serum creatinine\>3.0 mg/dl)
- Patients with emphysema or chronic bronchitis
- Patients with hepatic cirrhosis
- Patients with chronic intestinal diseases related to marked disorders of digestion or absorption
- Patients participated investigational drug trial within 1 month before entering this study
- Patients with any other serious diseases considered by the investigator not in the condition to enter the trial
Key Trial Info
Start Date :
April 1 2005
Trial Type :
INTERVENTIONAL
End Date :
February 1 2007
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00337337
Start Date
April 1 2005
End Date
February 1 2007
Last Update
October 18 2006
Active Locations (1)
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1
National Cheng-Kung University Hospital
Tainan, Taiwan, 704