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A Clinical Study to Evaluate the Effects of Akkermansia Muciniphila and Berberine on Prediabetes Among Obese Subjects.

NCT05720299 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 110

Last updated 2025-12-22

No results posted yet for this study

Summary

The Akkermania muciniphila may play an important role in the occurrence and development of Prediabetes. The purpose of this study was to evaluate the safety and efficacy of AKK in the treatment of Prediabetes among obese patients. In this study, a single center, randomized, double-blind, placebo-controlled design is adopted. 90 obese subjects with Prediabetes are included in this study, and are allocated to AKK group, BBR group, and placebo group at a ratio of 1:1:1. The study treatment lasts for 12 weeks. The changes of body fat, glucose metabolism, lipid metabolism indicators compared with the baseline at the end of the treatment will be analyzed. In addition, glucagon like peptide-1 (GLP-1) and inflammatory markers (hsCRP、TNF-α、IL-6、IL-8、IL-1β) in blood will be analyzed before and after treatment. The changes in fecal flora structure and the AKK bacteria also will be analyzed.

Conditions

Interventions

DRUG

Akkermansia muciniphila

one tablet of AKK

DRUG

Berberine

one tablet of Berberine

DRUG

Placebo

one tablet of placebo

Sponsors & Collaborators

  • Yu Chen

    lead OTHER

Principal Investigators

  • Yu Chen, Doctor · The Seventh Affiliated Hospital of Southern Medical University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-03-12
Primary Completion
2025-06-30
Completion
2025-06-30

Countries

  • China

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05720299 on ClinicalTrials.gov