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

ISRCTN ISRCTN90063632
DOI https://doi.org/10.1186/ISRCTN90063632
Protocol serial number 2006BAI04A04-02
Sponsor Ministry of Science and Technology of the People's Republic of China (China)
Funder Ministry of Science and Technology of the People's Republic of China, National Key Technology R&D Programme (China)
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

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

Study information

Primary study designInterventional
Study designRandomised double-blind placebo-controlled clinical trial
Secondary study designRandomised controlled trial
Study type Participant information sheet
Scientific title
Study objectivesSome 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) studiedType 2 diabetes/ cardiovascular diseases
Intervention1. 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 typeOther
Primary outcome measure(s)

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

Key secondary outcome measure(s)

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.

Completion date31/12/2010

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexAll
Target sample size at registration2000
Key inclusion criteria1. 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 criteria1. 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 enrolment01/03/2008
Date of final enrolment31/12/2010

Locations

Countries of recruitment

  • China

Study participating centre

Guang'an Men Hospital
Beijing
100053
China

Results and Publications

Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Participant information sheet Participant information sheet 11/11/2025 11/11/2025 No Yes
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