Clinical trial NCT00337337: Multiple Grain in Type 2 Diabetes
Official title: Effect of Reconstitute Multiple Grain on Glucose and Lipid Metabolism in Patients With Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Diabetes Mellitus
Keywords: Diabetes
rice
fiber
Lead sponsor: National Cheng-Kung University Hospital
Sponsor class: OTHER
First posted: 2006-06-15
Enrollment: 30
Sex: ALL
Minimum age (years): 25
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Changes in glycemic parameters including fasting plasma glucose, postprandial plasma glucose, insulin sensitivity and lipid profile
Secondary outcomes:
measure: Changes in body weight
measure: Acceptabiliy and tolerability
Other outcomes:
Locations:
city: Tainan
country: Taiwan
facility: National Cheng-Kung University Hospital
Study officials:
affiliation: National Cheng-Kung University Hospital
name: T-J Wu, MD
role: PRINCIPAL_INVESTIGATOR
References: