Overview

Effects of Berberine Hydrochloride and Bifidobacterium in Prediabetes Prevention and Treatment

Status:
Withdrawn
Trial end date:
2018-04-01
Target enrollment:
0
Participant gender:
All
Summary
The aim of this study is to assess the beneficial effects of Bifidobacterium and Berberine Hydrochloride on lowering glucose and delaying progress to diabetes in patients with prediabetes and to detect the potential mechanism.
Phase:
Phase 2/Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Xijing Hospital
Criteria
Inclusion Criteria:

- Informed consent obtained before any trial-related activities

- Male or female between 18 and 70 years of age

- 19≤Body mass index(BMI)≤30kg/m2

- No participate in any clinical trial at least 3 months

- Fasting blood glucose(FBG)<7.0mmol/L and 2-hour postprandial blood
glucose(2hPBG)<11.1mmol/L

- Females in child-bearing period should be given birth control

- No severe disease about heart, lung and kidney

- Ability and willingness to adhere to the protocol including performance of
self-monitored blood glucose (SMBG) profiles according to the protocol;

- Subject is likely to comply with the Investigators instruction.

Exclusion Criteria:

- Type 2 diabetes mellitus or type 1 diabetes mellitus

- Females of childbearing potential who are pregnant,breastfeeding or intend to become
pregnant or are not using adequate contraceptive methods

- Impaired liver function, defined as Aspartate aminotransferase(AST) or Alanine
transaminase(ALT)> 2 times upper limit of normal (central laboratory)

- Impaired renal function, defined as serum-creatinine≥133μmol/L

- Uncontrolled treated/untreated severe hypertension (systolic blood pressure≥160mmHg
and /or diastolic blood pressure≥95mmHg)

- Chronic gastrointestinal diseases

- Cancer and medical history of cancer (except basal cell skin cancer or squamous cell
skin cancer)

- Any clinically significant disease or disorder, which in the Investigator's opinion
could interfere with the results of the trial

- Mental incapacity, psychiatric disorder, unwillingness or language barriers precluding
adequate understanding or co-operation, including subjects not able to read and write

- Previous participation in this trial. Participation is defined as randomized.
Re-screening of screening failures is allowed only once within the limits of the
recruitment period

- Known or suspected hypersensitivity to trial products or related products

- Known or suspected abuse of alcohol, narcotics or illicit drugs.