Status:
UNKNOWN
Response of Gut Microbiota in Type 2 Diabetes to Hypoglycemic Agents
Lead Sponsor:
Peking Union Medical College Hospital
Collaborating Sponsors:
Chinese Academy of Sciences
Conditions:
Type2 Diabetes Mellitus
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
Brief Summary
Intestinal microflora refers to the trillions of microorganisms living in our gut, which is considered as an independent endocrine organ of human body. Intestinal microbiota plays a very important rol...
Detailed Description
In this study, T2DM patients who were free of anti-diabetic drugs or those have taken hypoglycemic drugs and ready to add a new drug were recruited, they were treated with metformin, α - glucosidase i...
Eligibility Criteria
Inclusion
- According to the diagnostic criteria of World Health Organization (WHO) in 1999, type 2 diabetes mellitus was diagnosed clinically
- The age ranged from 18 to 65 years (including 18 and 65 years)
- Free of hypoglycemic drugs in the past 3 months; or have taken hypoglycemic drugs, and other hypoglycemic drugs need to be added at present.
- Sign written consent form voluntarily
Exclusion
- Other types of diabetes mellitus
- At least in the last 1 month, no antibiotics or microbial agents have been used
- History of infectious diseases such as tuberculosis, viral hepatitis, HIV, and periodontal disease; history of dental disease
- Acute complications of diabetes mellitus within 6 months
- History of myocardial infarction or stroke within 6 months, or existing severe cardiovascular disease and risk
- Abnormal liver function \[i.e. serum alanine aminotransferase (ALT) or aspartate aminotransferase (AST) is 1.5 times higher than the upper limit of normal value\]；Abnormal renal function \[glomerular filtration rate≤60 ml/min\]
- Severe hypertension that defined as systolic blood pressure ≥160 mmHg, diastolic blood pressure ≥90 mmHg with drug therapy, or hypotension (resting seat blood pressure \< 90/50 mmHg)
- History of acute and chronic gastroenteritis or gastrointestinal surgery
- psychosis, alcohol dependence or history of drug abuse, lactation women, participation in other studies three months before the trial, allergic constitution or allergic to a variety of drug and those researchers think inappropriate to the research.
Key Trial Info
Start Date :
March 2 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 2 2021
Estimated Enrollment :
180 Patients enrolled
Trial Details
Trial ID
NCT04287387
Start Date
March 2 2020
End Date
March 2 2021
Last Update
February 27 2020
Active Locations (1)
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1
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China, 100730