Prevention of pre-diabetes in adults
| ISRCTN | ISRCTN86375169 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN86375169 |
| Protocol serial number | Project No: 2009BAI77B06 (the National Key Technology R&D Program) |
| Sponsor | Ministry of Science and Technology of The People's Republic of China (China) |
| Funder | This project was funded by the National Key Technology R&D Program (2009BAI77B06). |
- Submission date
- 02/09/2013
- Registration date
- 04/10/2013
- Last edited
- 04/10/2013
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Plain English summary of protocol
Background and study aims
This study focuses on the negative emotions that play an important role in the development of type 2 diabetes mellitus (T2DM) and its complications. Drug therapy, psychological therapy and psychological health education are used in this study to improve the patients blood glucose levels. We are looking for the right scheme for the prevention and management of pre-diabetes and T2DM. We are also looking for some psychological indicators which would be an early warning for T2DM.
Who can participate?
Individuals seeing a doctor in the participating hospitals in China.
What does the study involve?
Participants are randomly assigned to one of five groups: the control group (conventional diabetes education only), the metformin group, the psychological treatment group, the anti-depressant group, or the psychological health education group. Participants receive the respective treatments according to the group to which they belong; all participants also receive conventional diabetes education. All subjects are interviewed and take an oral glucose tolerance test (OGTT) at the beginning of the study and are followed up after 1 and 2 years of the study.
What are the possible benefits and risks of participating?
In addition to helping the participants improve negative emotion and lower their blood glucose, the project helped the hospitals and government provide the right scheme for the prevention and management of pre-diabetes and T2DM. There was no significant risk to participants of the study.
Where is the study run from?
This study is run from six hospitals in China.
When is the study starting and how long is it expected to run for?
The study started in May 2011 and ends in July 2014.
Who is funding the study?
The study is funded by the National Key Technology R&D Program.
Who is the main contact?
Prof. Xueli Sun
sunxueli58@163.com
Contact information
Scientific
28th Dianxin South road, Psychological Center
West China Hospital
Sichuan University
Sichuan
Chengdu
610041
China
| sunxueli58@163.com |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Multi-center randomized controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | Early identification and intervention on psychological problems in people in pre-diabetes |
| Study objectives | To evaluate the effectiveness of an intervention on negative emotions in pre-diabetic individuals that aimed to slow down and even reverse the development process from pre-diabetes to type 2 diabetes (T2DM). To explore the optimized scheme for early prevention, and identify psychological early warning indicators for this process. |
| Ethics approval(s) | Institutional Ethics Committee of Sichuan University, 21/12/2010, ref: 72 |
| Health condition(s) or problem(s) studied | Pre-diabetes in adults |
| Intervention | 500 subjects were randomly allocated to one of five groups: Group 1: conventional diabetes education (blank control) Group 2：conventional diabetes education + metformin Group 3: conventional diabetes education + cognitive-behavioral group therapy Group 4: conventional diabetes education + antidepressant (Seroxat) Group 5: conventional diabetes education + psychological health education |
| Intervention type | Other |
| Primary outcome measure(s) |
1. Changes of indicators of the oral glucose tolerance test and glycated hemoglobin reflecting the function of glycometabolism |
| Key secondary outcome measure(s) |
1. To explore the psychological characteristics of pre-diabetes in Chinese adults, including personality, coping style, social support, emotion, life satisfaction and alexithymia |
| Completion date | 31/07/2014 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 500 |
| Key inclusion criteria | 1. Aged 30-70 years 2. Fasting plasma glucose after a 75-g oral glucose tolerance test：>5.6 mmol/L,<7.0 mmol/L; or 2 h after a 75-g oral glucose tolerance test >7.8 mmol/L, <11.1 mmol/L 3. Glycated hemoglobin <8.0% |
| Key exclusion criteria | 1. Those eligible students who refused to participate 2. Women who were pregnant during the study, planning to get pregnant or lactating 3. People with type 1 diabetes or confirm there has significant clinical complications 4. Having acute myocardial infarction, unstable angina or heart failure within 3 months before screening 5. Using drugs which significantly affect the metabolism of sugar within 4 weeks before screening 6. Having a clinical diagnosis for malignant tumors and treatment within 5 years before screening 7. Having severe mental disorder or suicidal tendencies |
| Date of first enrolment | 01/05/2011 |
| Date of final enrolment | 31/07/2014 |
Locations
Countries of recruitment
- China
Study participating centre
610041
China
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not 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 |
