Multiple Grain in Type 2 Diabetes

Diabetes Mellitus Clinical Trial

Official title:

Effect of Reconstitute Multiple Grain on Glucose and Lipid Metabolism in Patients With Type 2 Diabetes

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00337337
• Other study ID #: NCKU-94-032
• Status: Recruiting
• Phase: Phase 4
• First received: June 14, 2006
• Last updated: October 17, 2006
• Start date: April 2005
• Est. completion date: February 2007

Study information

• Verified date: June 2006
• Source: National Cheng-Kung University Hospital
• Contact: HY Ou, MD
• Phone: 886-6-2353535
• Email: wahoryi[@]mail.ncku.edu.tw
• Is FDA regulated: No
• Health authority: Taiwan: Department of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: February 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 25 Years to 75 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus

Intervention

Behavioral:
• Multiple grain

• Ordinary Asian- rice

Locations

Country	Name	City	State
Taiwan	National Cheng-Kung University Hospital	Tainan

Sponsors (1)

Lead Sponsor	Collaborator
National Cheng-Kung University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in glycemic parameters including fasting plasma glucose, postprandial plasma glucose, insulin sensitivity and lipid profile
Secondary	Changes in body weight
Secondary	Acceptabiliy and tolerability