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Multiple Grain in Type 2 Diabetes

NCT ID: NCT00337337

Last Updated: 2006-10-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-04-30

Study Completion Date

2007-02-28

Brief Summary

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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

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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.

Conditions

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Diabetes Mellitus

Keywords

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Diabetes rice fiber

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Multiple grain

Intervention Type BEHAVIORAL

Ordinary Asian- rice

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

25 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Cheng-Kung University Hospital

OTHER

Sponsor Role lead

Principal Investigators

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T-J Wu, MD

Role: PRINCIPAL_INVESTIGATOR

National Cheng-Kung University Hospital

Locations

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National Cheng-Kung University Hospital

Tainan City, , Taiwan

Site Status RECRUITING

Countries

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Taiwan

Central Contacts

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HY Ou, MD

Role: CONTACT

Phone: 886-6-2353535

Email: [email protected]

Other Identifiers

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NCKU-94-032

Identifier Type: -

Identifier Source: org_study_id