Multiple Grain in Type 2 Diabetes

October 17, 2006 updated by: National Cheng-Kung University Hospital

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment

30

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Tainan, Taiwan, 704
        • Recruiting
        • National Cheng-Kung University Hospital
        • Sub-Investigator:
          • H-Y Ou, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Changes in glycemic parameters including fasting plasma glucose, postprandial plasma glucose, insulin sensitivity and lipid profile

Secondary Outcome Measures

Outcome Measure
Changes in body weight
Acceptabiliy and tolerability

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Cheng-Kung University Hospital

Investigators

  • Principal Investigator: T-J Wu, MD, National Cheng-Kung University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2005

Study Completion

February 1, 2007

Study Registration Dates

First Submitted

June 14, 2006

First Submitted That Met QC Criteria

June 14, 2006

First Posted (Estimate)

June 15, 2006

Study Record Updates

Last Update Posted (Estimate)

October 18, 2006

Last Update Submitted That Met QC Criteria

October 17, 2006

Last Verified

June 1, 2006

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NCKU-94-032

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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