Condition category
Nutritional, Metabolic, Endocrine
Date applied
10/06/2008
Date assigned
10/07/2008
Last edited
03/05/2011
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Xiao-Lin Tong

ORCID ID

Contact details

Guang'an Men Hospital
China Academy of Chinese Medical Sciences
No.5 Beixian Ge
Xuan Wu District
Beijing
100053
China

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 measures

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

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

http://www.most.gov.cn

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes