Ignite Creation Date:
2025-12-24 @ 11:20 PM
Ignite Modification Date:
2026-01-05 @ 11:56 AM
Study NCT ID:
NCT02082756
Status:
WITHDRAWN
Last Update Posted:
2018-11-14
First Post:
2014-03-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Berberine Hydrochloride and Bifidobacterium in Prediabetes Prevention and Treatment
Sponsor:
Xijing Hospital
Organization:
Study Overview
Official Title:
Effects of Berberine Hydrochloride and Bifidobacterium in Prediabetes Prevention and Treatment：an Open-label, Multicenter，Randomized, Prospective，Controlled Study
Status:
WITHDRAWN
Status Verified Date:
2018-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
The sponsor have not enough money to support this trial
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
Detailed Description:
Gut microbiota may play an important role in patients with prediabetes. Berberine, which is usually used as an antibiotic drug, has been reported a potential glucose-lowering effect in vitro and in vivo studies. Bifidobacterium, as a familiar probiotics, can modulate gut microbiota and improve glucose and lipid metabolism in animal experiments. Therefore, 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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: