Prediabetes
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1) Stable weight (less than or equal to 5% change in weight over the past 3 months) and obesity as defined by the Chinese standard BMI > 28 kg/m2; 2) PSQ score > 11 with one or more of the following sleep problems: difficulty falling asleep (sleep latency > 30 min), sleep maintenance disorders (>= 2 awakenings throughout the night), early awakenings, reduced sleep quality and reduced total sleep time (usually less than 6.5 h) with concomitant daytime dysfunction; 3) Absence of any cardiovascular disease and no infectious disease within the past 1 month; 4) not have taken any diets or medications, especially antibiotics and probiotics, within the past month that may interfere with glucose homeostasis and the microbiota. 5) Have and be able to use a smartphone with Apple iOS or Android operating system. 6) Have normal blood clotting. 7) Be between 18 and 65 years of age (including borderline values); 8) Voluntarily sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1) Regular use of drugs affecting body weight and blood glucose such as hypoglycaemic agents, glucocorticoids, niacin, ß-adrenergic agonists, thyroid hormones, contraceptive pills, diazepam, diuretics, phenytoin sodium, gamma-interferon, simethicone, etc., in the 1 month prior to screening; 2) Combination of various diseases that may significantly shorten life expectancy, such as malignant tumours, severe failure of various organ functions, etc; 3) Combination of various diseases that may seriously affect the subject's participation in this trial, such as psychosis, severe motor system abnormalities, etc; 4) Combination of ALT or AST > 2.5 times the upper limit of normal value, or blood creatinine > 1.5 mg/dl; 5) Pregnant or breastfeeding women, or women with pregnancy plans during the study period; 6) Chronic diarrhoea due to a combination of inflammatory bowel disease and irritable bowel syndrome; 7) those who, in the opinion of the investigator, should not be included in this trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| HbA1c;GLU; | — |
Secondary
| Measure | Time frame |
|---|---|
| Insulin;c-peptide;NA; | — |
Countries
China
Contacts
The First Affiliated Hospital of Xiamen University