Multiple Grain in Type 2 Diabetes | NCT00337337

Studies
Multiple Grain in Type 2 Diabetes

NCT00337337

Sponsor

National Cheng-Kung University Hospital

Status

Unknown status

Last Update Posted

Oct 18, 2006Estimated

Enrollment

Phase

Phase 4

Conditions

Diabetes Mellitus

Interventions

Multiple grain
Ordinary Asian- rice

Countries

Taiwan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2006

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2005

Primary Completion Date

Not provided

Completion Date

Feb 2007

First Submitted Date

Jun 14, 2006

First Submission Date that Met QC Criteria

Jun 14, 2006

First Posted Date

Jun 15, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 17, 2006

Last Update Posted Date

Oct 18, 2006Estimated

Description Module

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.

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
Changes in body weight
Acceptabiliy and tolerability

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

25 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
HY Ou, MD	Contact	886-6-2353535	2177	wahoryi@mail.ncku.edu.tw

Overall Officials

Name	Affiliation	Role
T-J Wu, MD	National Cheng-Kung University Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
National Cheng-Kung University Hospital	Recruiting	Tainan		704	Taiwan

Condition Browse Module

MeSH Terms

ID	Term
D003920	Diabetes Mellitus

Ancestor Terms

ID	Term
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases
D004700	Endocrine System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Name	Type	Description	Arm Group Labels	Other Names
Multiple grain	Behavioral
Ordinary Asian- rice	Behavioral