Plain English Summary
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
Trial website
Contact information
Type
Scientific
Primary contact
Prof Sun Xueli
ORCID ID
Contact details
28th Dianxin South road
Psychological Center
West China Hospital
Sichuan University
Sichuan
Chengdu
610041
China
sunxueli58@163.com
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
Project No: 2009BAI77B06 (the National Key Technology R&D Program)
Study information
Scientific title
Early identification and intervention on psychological problems in people in pre-diabetes
Acronym
Study hypothesis
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
Institutional Ethics Committee of Sichuan University, 21/12/2010, ref: 72
Study design
Multi-center randomized controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
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
Phase
Not Applicable
Drug names
Primary outcome measures
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 trial start date
01/05/2011
Overall trial end date
31/07/2014
Reason abandoned
Eligibility
Participant 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%
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
A total of 500 subjects were enrolled in the programme
Participant 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
Recruitment start date
01/05/2011
Recruitment end date
31/07/2014
Locations
Countries of recruitment
China
Trial participating centre
28th Dianxin South road, Psychological Center
Chengdu
610041
China
Sponsor information
Organisation
Ministry of Science and Technology of The People's Republic of China (China)
Sponsor details
B15th Fuxing road Beijing
Beijing
100862
China
bzxx@most.gov.cn
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
This project was funded by the National Key Technology R&D Program (2009BAI77B06).
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