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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:

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   (Adult, Senior)
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

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

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

ClinicalTrials.gov processed this record on September 23, 2016