Pre-diabetes in adults Nutritional, Metabolic, Endocrine Diabetes mellitus
Conditions
Interventions
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
Sponsors
Ministry of Science and Technology of The People's Republic of China (China)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Aged 30-70 years 2. Fasting plasma glucose after a 75-g oral glucose tolerance test:>5.6 mmol/L,7.8 mmol/L, <11.1 mmol/L 3. Glycated hemoglobin <8.0%
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
China
Outcome results
None listed