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The Potential Effects and Mechanisms of Flax Lignans on Type 2 Diabetes Mellitus
This study has been completed.
Sponsor:
Chinese Academy of Sciences
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
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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 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:
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 |
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) |
| 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 Contacts provided below.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00363233
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 |
Keywords provided by Chinese Academy of Sciences:
|
type 2 diabetes lignans flaxseed cholesterol |
Additional relevant MeSH terms:
|
Diabetes Mellitus Diabetes Mellitus, Type 2 Hypercholesterolemia Glucose Metabolism Disorders Metabolic Diseases |
Endocrine System Diseases Hyperlipidemias Dyslipidemias Lipid Metabolism Disorders |
ClinicalTrials.gov processed this record on July 21, 2017