NCT00337337

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for phase_4 diabetes-mellitus

Timeline
Completed

Started Apr 2005

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2005

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

June 14, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 15, 2006

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2007

Completed
Last Updated

October 18, 2006

Status Verified

June 1, 2006

First QC Date

June 14, 2006

Last Update Submit

October 17, 2006

Conditions

Diabetes Mellitus

Keywords

Diabetesricefiber

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (2)

  • Changes in body weight

  • Acceptabiliy and tolerability

Interventions

Multiple grainBEHAVIORAL
Ordinary Asian- riceBEHAVIORAL

Eligibility Criteria

Age25 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Cheng-Kung University Hospital

Tainan, 704, Taiwan

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • T-J Wu, MD

    National Cheng-Kung University Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

HY Ou, MD

CONTACT

886-6-2353535wahoryi@mail.ncku.edu.tw

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 14, 2006

First Posted

June 15, 2006

Study Start

April 1, 2005

Study Completion

February 1, 2007

Last Updated

October 18, 2006

Record last verified: 2006-06

Locations

TW(1)