ITMCTR2000003781
Recruiting
Phase 1
Study on the preventive and therapeutic effect of Cordyceps militaris on patients with chronic obstructive pulmonary disease and insulin resistance based on gut microbiota
Conditionschronic obstructive pulmonary disease
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- chronic obstructive pulmonary disease
- Sponsor
- Shanghai Sixth People's Hospital East Campus
- Status
- Recruiting
- Last Updated
- 3 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Patients with chronic obstructive pulmonary disease (COPD), aged 45\-75 years, of all genders, were enrolled in the insulin resistance COPD group according to the insulin resistance index (HOMA\-IR) \>\= 2\.29, and the healthy control group was also collected.
- •in line with the 2013 edition of global initiative for chronic obstructive pulmonary disease (gold): FEV1 / FVC accounted for less than 70% of the predicted value after using bronchodilators; chronic airway symptoms, including cough, dyspnea and chronic airway obstruction, were present; all patients were in clinical stable stage. The clinical stable period was defined as: no acute exacerbation symptoms, no use of hormone or antibiotics within 6 weeks before inclusion, and the dosage of inhaled drug dosage form remained unchanged; insulin resistance index (HOMA\-IR) \>\= 2\.29\.
Exclusion Criteria
- •(1\) At the same time, patients with suspected ACOS and confirmed ACOS were also accompanied by other clinical features related to asthma and pulmonary function, suggesting that FEV1 improvement rate was more than 12% and absolute value was higher than 200 ml.
- •(2\) Pulmonary function indicated that there were restrictive ventilation dysfunction.
- •(3\) Chest CT showed pneumonia, pulmonary abscess, active pulmonary tuberculosis, bronchiectasis, lung tumor, pulmonary interstitial disease, diffuse panbronchiolitis, pleural effusion, pneumothorax and other respiratory diseases.
- •(4\) Combined with metabolic diseases: type 1 diabetes mellitus, hyperlipidemia, overweight or obesity (body mass index \>\= 24 kg/m2\), etc.
- •(5\) Combined with cardiovascular diseases: including heart failure, hypertension, atherosclerosis, etc.
- •(6\) There are no known gastrointestinal diseases including irritable bowel syndrome, ulcerative colitis, and no history of bariatric surgery or drugs known to affect the immune system
- •(7\) Other systemic diseases include cirrhosis, nonalcoholic cirrhosis and chronic kidney disease.
- •(8\) Patients with cognitive impairment or mental disorder were unable to complete the COPD assessment test (CAT) questionnaire and the modified British Medical Research Council (MMRC) respiratory questionnaire.
- •(9\) Metformin, acarbose, antibiotics, microbial preparations, lactulose, etc. within 6 weeks.
- •(10\) Serious picky food, excessive drinking and overeating.
Outcomes
Primary Outcomes
Not specified
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