Research on the comprehensive therapy for impaired glucose tolerance (IGT) by traditional Chinese medicine

Completed

• Conditions: Type 2 diabetes/ cardiovascular diseases; Nutritional, Metabolic, Endocrine; Non-insulin-dependent diabetes mellitus

• Registration Number: ISRCTN90063632
• Lead Sponsor: Ministry of Science and Technology of the People's Republic of China (China)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-07-10
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 2000

Inclusion Criteria

1. Both males and females
2. 25 =< age <=70
3. Intravenous plasma glucose: Fasting plasma glucose (FPG) <7.0 mmol/L and 2-hour plasma glucose (2hPG) of oral glucose tolerance test (OGTT) <11.1 mmol/L, >=7.8 mmol/L
4. Deficiency of both qi and yin syndromes accompanied by heat
5. Taking no medicine for treatment of IGT
6. 18.5 kg/m2 < body mass index (BMI) <30 kg/m2
7. Voluntariness, and signed letter of consent
8. Those who do not take part in any other trails within 3 months

Exclusion Criteria

1. Acute cardiovascular disease and myocardial infarction within 6 months
2. Proliferative retinopathy that needs to be treated by laser
3. Not compliant
4. Mental disease
5. Pregnant or lactating women; women without contraception
6. Allergic to any traditional chinese medicine
7. Co-morbid with other endocrine disease or serious protopathy
8. Systolic blood pressure (SBP) >= 160 mmHg, diastolic blood pressure (DBP) >= 100 mmHg and secondary hypertension
9. Cholesterol (CHO) >= 6.22 mmol/L(240 mg/dl) or low density lipoprotein (LDL) >= 4.14 mmol/L (160 mg/dl)
10. Patients who are treated by other hypoglycemic drug

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Blood glucose (FPG and 2hPG of OGTT) at baseline, and every 3 months during intervention (3 years) and follow-up (6 months).