Research on the comprehensive therapy for impaired glucose tolerance (IGT) by traditional Chinese medicine
| ISRCTN | ISRCTN90063632 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN90063632 |
| Secondary identifying numbers | 2006BAI04A04-02 |
- Submission date
- 10/06/2008
- Registration date
- 10/07/2008
- Last edited
- 03/05/2011
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Xiao-Lin Tong
Scientific
Scientific
Guang'an Men Hospital
China Academy of Chinese Medical Sciences
No.5 Beixian Ge
Xuan Wu District
Beijing
100053
China
Study information
| Study design | Randomised double-blind placebo-controlled clinical trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Participant information sheet | Patient information can be found at: http://www.gamh.com.cn/tangniaobing/zqtys.htm (in Chinese) |
| Scientific title | |
| Study objectives | 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(s) | Medical Ethics Committee, Guang'an Men Hospital, China Academy of Chinese Medical Sciences. on 28/02/2008 |
| Health condition(s) or problem(s) studied | 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 |
| 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 study start date | 01/03/2008 |
| Completion date | 31/12/2010 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 2,000 (As of 03/05/2011; 804 particpated) |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/03/2008 |
| Date of final enrolment | 31/12/2010 |
Locations
Countries of recruitment
- China
Study participating centre
Guang'an Men Hospital
Beijing
100053
China
100053
China
Sponsor information
Ministry of Science and Technology of the People's Republic of China (China)
Government
Government
Yi NO.15
Fu-xing Street
Beijing
100862
China
| Website | http://www.most.gov.cn |
|---|---|
"ROR" |
https://ror.org/027s68j25 |
Funders
Funder type
Government
Ministry of Science and Technology of the People's Republic of China, National Key Technology R&D Programme (China)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
