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ClinicalTrials.gov Identifier: NCT00337337
Verified June 2006 by National Cheng-Kung University Hospital. Recruitment status was: Recruiting
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 patients.
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 frequently associated with low GI. In many single-blind cross-over study, short term consumption of high fiber meal has been shown to enhance postprandial insulin sensitivity in healthy subjects. We presume that increasing daily consumption of fiber would improve the insulin resistance and therefor glycemic parameters patients with DM. Patients with type 2 diabetes with stable dose of hypoglycemic medication control will be recruited, two types of meals will be given, type A is a general Asian rice-meal and type B consists of the same rice with multiple-grain-fiber added. Both type of meals will be consumed for 3 months by each patients.
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Ages Eligible for Study:
25 Years to 75 Years (Adult, Senior)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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.
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