The Potential Effects and Mechanisms of Flax Lignans on T... | NCT00363233

Studies
The Potential Effects and Mechanisms of Flax Lignans on Type 2 Diabetes Mellitus

NCT00363233

Sponsor

Chinese Academy of Sciences

Status

Completed

Last Update Posted

Jan 9, 2007Estimated

Enrollment

Phase

Phase 2Phase 3

Conditions

Type 2 Diabetes
Hypercholesterolemia

Interventions

flax lignans

Countries

China

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

Jan 2007

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2006

Primary Completion Date

Not provided

Completion Date

Dec 2006

First Submitted Date

Aug 10, 2006

First Submission Date that Met QC Criteria

Aug 11, 2006

First Posted Date

Aug 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

Jan 8, 2007

Last Update Posted Date

Jan 9, 2007Estimated

Description Module

Brief Summary

The purpose of the study is to improving the lipid profile and glucose control in type 2 diabetic patients with supplementation of flax lignans. We hypothesize that flax lignans supplement will improve the cholesterol profile and glucose control in type 2 diabetic patients.

Detailed Description

The prevalence of type 2 diabetes is increasing dramatically in the last decade in China. Hyperlipidemia is a comorbid condition in type 2 diabetes and increase the adverse health outcomes. Flax lignans, a phytoestrogen found in flaxseed is thought to be the compound responsible for cholesterol-lowering effect of flaxseed. Our purpose is to improving the lipid profile in type 2 diabetic patients with supplementation of flax lignans.

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 2Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

Name	Type	Description	Arm Group Labels	Other Names
flax lignans	Drug

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Total cholesterol at 3 months

Secondary Outcomes

Measure	Description	Time Frame
LDL and triglycerides at 3 months; Blood glucose and HbA1C at 3 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Diagnosed type 2 diabetes
Age: 50-79 years old
LDL-cholesterol more than 2.9 mmol/l

Exclusion Criteria:

Current or previous (within 6 months) use of estrogen therapy
Cancer
Chronic gastrointestinal diseases
Current use of antibiotics
Any severe liver or renal diseases
Systolic blood pressure more than 180 mmHg or phase 3 hypertension
Any severe mental diseases
Severe cardio- or cerebro-vascular diseases

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

50 Years

Maximum Age

79 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Xu Lin, MD, PhD	Institute for Nutritional Sciences, Chinese Academy of Sciences	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Institute for Nutritional Sciences, Chinese Academy of Sciences; Huadong Hospital		Shanghai	Shanghai Municipality	200031	China

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
17987126	Derived	Pan A, Sun J, Chen Y, Ye X, Li H, Yu Z, Wang Y, Gu W, Zhang X, Chen X, Demark-Wahnefried W, Liu Y, Lin X. Effects of a flaxseed-derived lignan supplement in type 2 diabetic patients: a randomized, double-blind, cross-over trial. PLoS One. 2007 Nov 7;2(11):e1148. doi: 10.1371/journal.pone.0001148.

ID	Term
D003924	Diabetes Mellitus, Type 2
D006937	Hypercholesterolemia

ID	Term
D003920	Diabetes Mellitus
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases