Diabetes Mellitus
Conditions
Keywords
Diabetes, rice, fiber
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 patients.
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 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.
Interventions
BEHAVIORALMultiple grain
BEHAVIORALOrdinary Asian- rice
Sponsors
National Cheng-Kung University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
25 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* 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 criteria
* 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in glycemic parameters including fasting plasma glucose, postprandial plasma glucose, insulin sensitivity and lipid profile | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes in body weight | — |
| Acceptabiliy and tolerability | — |
Countries
Taiwan
Contacts
Primary ContactHY Ou, MD
Outcome results
None listed