Overview

A Study on the Efficacy and Gut Microbiota of Berberine and Probiotics in Patients With Newly Diagnosed Type 2 Diabetes

Status:
Unknown status
Trial end date:
2019-05-01
Target enrollment:
0
Participant gender:
All
Summary
The purpose of this study is to conduct a multicenter randomized, double-blind, placebo-controlled clinical trial, evaluating the effects and change of gut microbiota after berberine and/or probiotics administration in patients with newly diagnosed type 2 diabetes
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Shanghai Jiao Tong University School of Medicine
Treatments:
Diphenhydramine
Promethazine
Criteria
Main Inclusion Criteria:

1. Newly diagnosed type 2 diabetes defined as WHO (1999) diagnostic criteria ; Both
Genders Eligible;

2. Age: ≥20 and <70 years;

3. BMI: 19.0 ~ 35.0kg/m2;

4. Not receive previously with anti-diabetic agents (oral agents, GLP-1 or insulin);

5. Have at least 2 months of life style intervention to control blood glucose before
screening;

6. HbA1c ≥6.5% and ≤10.0%, and fasting plasma glucose≥7.0 mmol/L and ≤13.3mmol/L at
screening.

Details please see the study protocol. -

Main Exclusion Criteria:

1. Significant impaired liver function (defined as alanine transaminase (ALT)> 2.5 times
upper limit of normal); Impaired renal function (defined as serum-creatinine>
132μmol/L or eGFR <60 mL/min/1.73m2 ); Mental disease, severe infection, severe
anemia, neutropenia disease;

2. Other severe heart disease, such as congenital heart disease, rheumatic heart disease,
hypertrophic or dilated cardiomyopathy, defined as New York Heart Association class
III or IV;

3. Allergic to gentamicin or other amino glycosides antibiotics;

4. Histories of acute diabetic complications including diabetic ketoacidosis or
hyperosmolar hyperglycemic non-ketotic coma within 3 months;

5. Pregnancy;

6. Acute and chronic diarrhea or severe constipation of the digestive tract diseases;

7. Medical history of malignant tumor (except local skin basal cell carcinoma) in the
past 5 years;

8. Medical history of intestine, or other digestive tract surgery (such as
cholecystectomy) within one year, or other non gastrointestinal surgery within 6
months.

Details please see the study protocol.

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