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

This study has been completed.

Sponsor:

Information provided by:

Chinese Academy of Sciences

ClinicalTrials.gov Identifier:

NCT00363233

First received: August 10, 2006

Last updated: January 8, 2007

Last verified: January 2007

History of Changes

Purpose

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.

Condition	Intervention	Phase
Type 2 Diabetes Hypercholesterolemia	Drug: flax lignans	Phase 2 Phase 3


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Crossover Assignment Masking: Double-Blind Primary Purpose: Treatment
Official Title:	The Effects of Flax Lignans on Lipid Profile and Glucose Management in Type 2 Diabetes: a Randomized Double-Blind Cross-Over Study

Resource links provided by NLM:

MedlinePlus related topics: Cholesterol

Genetic and Rare Diseases Information Center resources: Sphingolipidosis

U.S. FDA Resources

Further study details as provided by Chinese Academy of Sciences:

Primary Outcome Measures:

Total cholesterol at 3 months

Secondary Outcome Measures:

LDL and triglycerides at 3 months; Blood glucose and HbA1C at 3 months


Estimated Enrollment:	80
Study Start Date:	March 2006
Estimated Study Completion Date:	December 2006

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.

Eligibility


Ages Eligible for Study:	50 Years to 79 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00363233

Locations


China, Shanghai
Institute for Nutritional Sciences, Chinese Academy of Sciences; Huadong Hospital
Shanghai, Shanghai, China, 200031

Sponsors and Collaborators

Chinese Academy of Sciences

Investigators


Principal Investigator:	Xu Lin, MD, PhD	Institute for Nutritional Sciences, Chinese Academy of Sciences

More Information

No publications provided by Chinese Academy of Sciences

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.


ClinicalTrials.gov Identifier:	NCT00363233 History of Changes
Other Study ID Numbers:	04DZ14007
Study First Received:	August 10, 2006
Last Updated:	January 8, 2007
Health Authority:	China: Ethics Committee

Keywords provided by Chinese Academy of Sciences:


type 2 diabetes lignans flaxseed cholesterol

Additional relevant MeSH terms:


Diabetes Mellitus, Type 2 Hypercholesterolemia Diabetes Mellitus Dyslipidemias Endocrine System Diseases	Glucose Metabolism Disorders Hyperlipidemias Lipid Metabolism Disorders Metabolic Diseases

ClinicalTrials.gov processed this record on March 03, 2015

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