Multiple Grain in Type 2 Diabetes

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2006 by National Cheng-Kung University Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
National Cheng-Kung University Hospital
ClinicalTrials.gov Identifier:
NCT00337337
First received: June 14, 2006
Last updated: October 17, 2006
Last verified: June 2006
  Purpose

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.


Condition Intervention Phase
Diabetes Mellitus
Behavioral: Multiple grain
Behavioral: Ordinary Asian- rice
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Effect of Reconstitute Multiple Grain on Glucose and Lipid Metabolism in Patients With Type 2 Diabetes

Resource links provided by NLM:


Further study details as provided by National Cheng-Kung University Hospital:

Primary Outcome Measures:
  • Changes in glycemic parameters including fasting plasma glucose, postprandial plasma glucose, insulin sensitivity and lipid profile

Secondary Outcome Measures:
  • Changes in body weight
  • Acceptabiliy and tolerability

Estimated Enrollment: 30
Study Start Date: April 2005
Estimated Study Completion Date: February 2007
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

Ages Eligible for Study:   25 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00337337

Contacts
Contact: HY Ou, MD 886-6-2353535 ext 2177 wahoryi@mail.ncku.edu.tw

Locations
Taiwan
National Cheng-Kung University Hospital Recruiting
Tainan, Taiwan, 704
Sub-Investigator: H-Y Ou, MD         
Sponsors and Collaborators
National Cheng-Kung University Hospital
Investigators
Principal Investigator: T-J Wu, MD National Cheng-Kung University Hospital
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00337337     History of Changes
Other Study ID Numbers: NCKU-94-032
Study First Received: June 14, 2006
Last Updated: October 17, 2006
Health Authority: Taiwan: Department of Health

Keywords provided by National Cheng-Kung University Hospital:
Diabetes
rice
fiber

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on July 20, 2014