Prevention of pre-diabetes in adults
- Conditions
- Pre-diabetes in adultsNutritional, Metabolic, EndocrineDiabetes mellitus
- Registration Number
- ISRCTN86375169
- Lead Sponsor
- Ministry of Science and Technology of The People's Republic of China (China)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 500
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%
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Changes of indicators of the oral glucose tolerance test and glycated hemoglobin reflecting the function of glycometabolism<br>2. Numerous neuroendocrine indicators reflecting the function of the hypothalamic-pituitary-adrenal axis and the hypothalamic-pituitary-thyroid axis<br>3. Numerous psychological tests reflecting personality, coping style, social support, emotion, life satisfaction and alexithymia<br><br>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
Name Time Method 1. To explore the psychological characteristics of pre-diabetes in Chinese adults, including personality, coping style, social support, emotion, life satisfaction and alexithymia<br>2. The relationship between those psychological indicators and neuroendocrine indicators or glycometabolism<br>3. At the end of study, a warning scale for T2DM should be designed and can be applied in practice