Multiple Grain in Type 2 Diabetes

Phase 4

• Conditions: Diabetes Mellitus

• Registration Number: NCT00337337
• Lead Sponsor: National Cheng-Kung University Hospital

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.

Study Timeline

• Study Start: 2005-04
• Status Verified: 2006-06
• Study First Submitted: 2006-06-14
• Study First Submitted QC: 2006-06-14
• Study First Posted: 2006-06-15
• Last Update Submitted: 2006-10-17
• Last Update Posted: 2006-10-18
• Study Completion: 2007-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Changes in glycemic parameters including fasting plasma glucose, postprandial plasma glucose, insulin sensitivity and lipid profile

Secondary Outcome Measures

Name	Time	Method
Changes in body weight
Acceptabiliy and tolerability

Trial Locations

Locations (1)

National Cheng-Kung University Hospital; 🇨🇳 Tainan, Taiwan