Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
2006BAI04A04-02
Study information
Scientific title
Acronym
Study hypothesis
Some randomised controlled trials have specifically examined the effects of lifestyle and drug interventions on the prevention of type 2 diabetes. The aim of our randomised controlled trial is to study the effects of traditional Chinese medicine on the prevention of type 2 diabetes, which has not yet been carried out to date.
Hypothesis:
Lifestyle intervention combined with traditional Chinese medicine could reverse IGT to normal, and decrease associated risks of type 2 diabetes and cardiovascular diseases.
Ethics approval
Medical Ethics Committee, Guang'an Men Hospital, China Academy of Chinese Medical Sciences. on 28/02/2008
Study design
Randomised double-blind placebo-controlled clinical trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Patient information can be found at: http://www.gamh.com.cn/tangniaobing/zqtys.htm (in Chinese)
Condition
Type 2 diabetes/ cardiovascular diseases
Intervention
1. Traditional Chinese medicine Tian-qi Jiang-tang Capsule™, 5 capsules three times a day, combined with lifestyle interventions
2. Placebo combined with lifestyle interventions
Lifestyle interventions: Diabetes experts will give a talk on physical exercise and diet to a group of participants at baseline, lasting about 45 minutes. In addition, the researchers (usually doctors) will give advice to the participants individually at baseline and every 3 months. We will examine the results of the lifestyle interventions every 3 month by questionnaires, and will adjust the individual advice according to the results of the questionnaires.
Total duration of interventions: 3 years
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measure
Blood glucose (FPG and 2hPG of OGTT) at baseline, and every 3 months during intervention (3 years) and follow-up (6 months).
Secondary outcome measures
Risk of cardiovascular disease, assessed by the following:
1. Blood lipid, assessed at baseline, 6, 12, 18, 24, 30 and 36 months
2. Blood pressure, measured at baseline and then every 3 months during the intervention (3 years) and follow-up (6 months)
3. BMI, measured every 3 months during the intervention (3 years) and follow-up (6 months)
4. Electrocardiogram (ECG), carried out every 6 months during the intervention (3 years)
The following will be assessed in a sub-group of approximately 500 participants:
1. HbA1c, assessed every 6 months during the intervention (3 years)
2. Urinary albumin excretion rate (UAER), assessed at baseline, at 3, 6, 12 and 36 months
3. High-sensitivity C-reactive protein (hs-CRP) baseline, 12 and 36 months
4. Adiponection, baseline, 12 and 36 months
5. OGTT:
5.1. At baseline (0 hour), assessed at baseline and every 3 month during the intervention (3 years) and follow-up (6 months)
5.2. 0.5 hours, assessed at baseline, 6, 12, 24 and 36 months
5.3. 1 hour, assessed at baseline, 12 and 36 months
5.4. 2 hours, assessed at baseline and then every 3 months during the intervention (3 years) and follow-up (6 months)
6. Insulin level:
6.1. Baseline insulin level, measured at baseline (0 month) and every three months until 12 months, and then 24 and 36 months
6.2. Insulin level at 0.5 hours, measured at baseline (0 month) and every three months until 12 months, and then 24 and 36 months
6.3. Insulin level at 1 hour, measured at baseline (0 month), 12 and 36 months
6.4. Insulin level at 2 hours, measured at baseline, every three months until 12 months, and then 24 and 36 months
Note: We will choose the participants who will likely to be compliant for the sub-group study.
Overall trial start date
01/03/2008
Overall trial end date
31/12/2010
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
2,000 (As of 03/05/2011; 804 particpated)
Participant 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
Recruitment start date
01/03/2008
Recruitment end date
31/12/2010
Locations
Countries of recruitment
China
Trial participating centre
Guang'an Men Hospital
Beijing
100053
China
Sponsor information
Organisation
Ministry of Science and Technology of the People's Republic of China (China)
Sponsor details
Yi NO.15
Fu-xing Street
Beijing
100862
China
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
Ministry of Science and Technology of the People's Republic of China, National Key Technology R&D Programme (China)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list