Prevention of pre-diabetes in adults
| ISRCTN | ISRCTN86375169 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN86375169 |
| Secondary identifying numbers | Project No: 2009BAI77B06 (the National Key Technology R&D Program) |
- 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
| Study design | Multi-center randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient 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 | 1. Changes of indicators of the oral glucose tolerance test and glycated hemoglobin reflecting the function of glycometabolism 2. Numerous neuroendocrine indicators reflecting the function of the hypothalamic-pituitary-adrenal axis and the hypothalamic-pituitary-thyroid axis 3. Numerous psychological tests reflecting personality, coping style, social support, emotion, life satisfaction and alexithymia Outcome measures were assessed at baseline (T0) before the intervention, reassessed at 1 year and 2 years after the intervention, and then analyzed the psychological warning indicator of psychosomatic disease and optimization scheme for prevention of psychosomatic disease such as T2DM. |
| Secondary outcome measures | 1. To explore the psychological characteristics of pre-diabetes in Chinese adults, including personality, coping style, social support, emotion, life satisfaction and alexithymia 2. The relationship between those psychological indicators and neuroendocrine indicators or glycometabolism 3. At the end of study, a warning scale for T2DM should be designed and can be applied in practice |
| Overall study start date | 01/05/2011 |
| Completion date | 31/07/2014 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | A total of 500 subjects were enrolled in the programme |
| 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
Sponsor information
Government
B15th Fuxing road Beijing
Beijing
100862
China
| bzxx@most.gov.cn | |
| Website | http://www.most.gov.cn/bszn/index.htm |
"ROR" |
https://ror.org/027s68j25 |
Funders
Funder type
Government
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 |
