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Multiple Grain in Type 2 Diabetes

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ClinicalTrials.gov Identifier: NCT00337337
Recruitment Status : Unknown
Verified June 2006 by National Cheng-Kung University Hospital.
Recruitment status was:  Recruiting
First Posted : June 15, 2006
Last Update Posted : October 18, 2006
Sponsor:
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus Behavioral: Multiple grain Behavioral: Ordinary Asian- rice Phase 4

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  (Clinical Trial)
Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effect of Reconstitute Multiple Grain on Glucose and Lipid Metabolism in Patients With Type 2 Diabetes
Study Start Date : April 2005
Study Completion Date : February 2007

Resource links provided by the National Library of Medicine

U.S. FDA Resources




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

Secondary Outcome Measures :
  1. Changes in body weight
  2. Acceptabiliy and tolerability


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Ages Eligible for Study:   25 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

ClinicalTrials.gov Identifier: NCT00337337     History of Changes
Other Study ID Numbers: NCKU-94-032
First Posted: June 15, 2006    Key Record Dates
Last Update Posted: October 18, 2006
Last Verified: June 2006

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

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