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The Study of the Effects of Soy Isoflavones on the Metabolism of Glucose and Lipids in Postmenopausal Chinese Women With Impaired Glucose Regulation


N/A
30 Years
70 Years
Not Enrolling
Female
Type 2 Diabetes Mellitus

Thank you

Trial Information

The Study of the Effects of Soy Isoflavones on the Metabolism of Glucose and Lipids in Postmenopausal Chinese Women With Impaired Glucose Regulation


Subjects were Chinese adult women, age 30-70 year, with an FG concentration ranging from 5.6
to 7.0 mmol/L or 2-h PG concentration ranging from 7.8-11.0 mmol/L or with newly diagnosed
diabetes not requiring medication treatment according to a doctor's suggestion or
participants did not willing to take medication themselves, and managed their diabetes just
with a stable diet and exercise. Women were excluded if they had a history of coronary heart
disease, stoke, thyroid disease, severe liver, lung, or gastrointestinal tract diseases;
were currently or in the past 8 weeks used hypoglycemic or lipid-lowering or
weight-reduction agents; were occurrence of diabetic complications; use of hormone
replacement therapy; allergy to soy;were long-term antibiotics users.


Inclusion Criteria:



- Chinese women aged 30-70 y

- Fasting glucose >=5.6 mmol/l; post-load glucose >=7.8 mmol/l

Exclusion Criteria:

- Diabetes renal diseases

- Confirmed CVD, chronic liver,kidney diseases,Thyroid disease

- Medications affecting glucose or lipid metabolism

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Outcome Measure:

Percentage Change in Fasting Plasma Glucose

Outcome Description:

(6th month value-baseline value)/baseline value*100%

Outcome Time Frame:

Baseline,6 months

Safety Issue:

No

Principal Investigator

Yan-bin Ye, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Sun Yat-sen University

Authority:

China: Ministry of Health

Study ID:

yanbinye

NCT ID:

NCT00951912

Start Date:

August 2009

Completion Date:

September 2011

Related Keywords:

  • Type 2 Diabetes Mellitus
  • genistein
  • daidzein
  • impaired glucose regulation
  • glucose metabolism
  • lipids metabolism
  • inflammation
  • women
  • Diabetes Mellitus
  • Diabetes Mellitus, Type 2

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