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

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ClinicalTrials.gov Identifier: NCT00363233
Recruitment Status : Completed
First Posted : August 15, 2006
Last Update Posted : January 9, 2007
Sponsor:
Information provided by:
Chinese Academy of Sciences

Study Description
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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.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Hypercholesterolemia Drug: flax lignans Phase 2 Phase 3

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double
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
Study Start Date : March 2006
Study Completion Date : December 2006

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Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. Total cholesterol at 3 months

Secondary Outcome Measures :
  1. LDL and triglycerides at 3 months; Blood glucose and HbA1C at 3 months

Eligibility Criteria
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Ages Eligible for Study:   50 Years to 79 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00363233


Locations
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China, Shanghai
Institute for Nutritional Sciences, Chinese Academy of Sciences; Huadong Hospital
Shanghai, Shanghai, China, 200031
Sponsors and Collaborators
Chinese Academy of Sciences
Investigators
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Principal Investigator: Xu Lin, MD, PhD Institute for Nutritional Sciences, Chinese Academy of Sciences
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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ClinicalTrials.gov Identifier: NCT00363233    
Other Study ID Numbers: 04DZ14007
First Posted: August 15, 2006    Key Record Dates
Last Update Posted: January 9, 2007
Last Verified: January 2007
Keywords provided by Chinese Academy of Sciences:
type 2 diabetes
lignans
flaxseed
cholesterol
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Hypercholesterolemia
Glucose Metabolism Disorders
Metabolic Diseases
 Endocrine System Diseases
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders