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

NCT05720299 | Completed

• 1 other identifier: ZY19-202201
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

Brief 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

Prediabetes

Keywords

Akkermania muciniphila; obesity; metabolism; fecal flora; Prediabetes

Outcome Measures

Primary Outcomes (1)

• HbA1c after 12weeks

  Change from baseline in HbA1c

  Baseline , Day84

Secondary Outcomes (8)

• Weight after 12weeks

  Baseline , Day84

• Fasting and OGTT 2h blood glucose levels after 12weeks

  Baseline , Day84

• HOMA-IR after 12weeks

  Baseline , Day84

• Fasting and OGTT 2h insulin and C-peptide levels after 12weeks

  Baseline , Day84

• BMI, waist circumference, waist-to-hip ratio after 12weeks

  Baseline , Day84

Study Arms (3)

Akkermansia muciniphila group(AKK)

EXPERIMENTAL

They will be treated with one tablet of AKK, twice a day, for 12 weeks.

Drug: Akkermansia muciniphila

Berberine group

EXPERIMENTAL

They will be treated with one tablet of Berberine, twice a day, for 12 weeks.

Drug: Berberine

Placebo group

PLACEBO COMPARATOR

They will be treated with one tablet of placebo, twice a day, for 12 weeks.

Drug: Placebo

Interventions

Akkermansia muciniphila DRUG

one tablet of AKK

Akkermansia muciniphila group(AKK)

Berberine DRUG

one tablet of Berberine

Berberine group

Placebo DRUG

one tablet of placebo

Placebo group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged 18-65
• Overweight/obesity (24.0≤BMI≤40.0 kg/m\^2)
• Fasting blood glucose ≥6.1 and \<7.0 mmol/L, or 2-hour postprandial blood glucose ≥7.8 and \<11.1 mmol/L, or glycosylated hemoglobin ≥5.7% and \<6.5%
• Fertile subjects (including male and female subjects) agreed to take effective contraceptive measures that the investigator accepted during and within 3 months after the trial (e.g. intrauterine device or a condom); the fertile female subjects with serum human chorionic gonadotropin test negative results within 7 days before the investigational product administration; Infertile female must be surgically infertile or at least 1 year after menopause.
• Subjects should understand the nature, significance, potential benefits, inconvenience and risks of the study before the trial begins, fully understand and voluntarily sign the informed consent.

You may not qualify if:

• Subjects who diagnosed with diabetes mellitus, medical obesity (excluding those who have been off medication for more than 1 year), or other secondary diabetes mellitus (e.g., Cushing's syndrome, thyroid dysfunction, or acromegaly);
• Subjects who has undergone bariatric surgery;
• Subjects who has acute or chronic progressive or unstable disease, liver and kidney insufficiency, serious cardiovascular and cerebrovascular diseases;
• Subjects with acute diabetic complications such as diabetic ketoacidosis or diabetic hypertonic coma within within latest 3 months; 4.Patients with hemolytic anemia or glucose-6-phosphate dehydrogenase deficiency; 5.History of intestinal or intestinal surgery within 1 year, or non-gastrointestinal surgery within 6 months; 6.Excessive alcohol consumption in the last 10 years (more than 30 g/ day for male and 20g/ day for female) 7.Pregnant or lactating subjects 8.Subjects that the investigator considers need to excluded due to other causes.

Sponsors & Collaborators

• Yu Chen: lead

Study Sites (1)

The Seventh Affiliated Hospital of Southern Medical University

Foshan, Guangdong, 514500, China

Location

MeSH Terms

Conditions

Prediabetic State; Obesity

Interventions

Berberine

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Overweight; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Berberine Alkaloids; Benzylisoquinolines; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring

Study Officials

• Yu Chen, Doctor

  The Seventh Affiliated Hospital of Southern Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Chief of Department of Gastroenterology

Study Record Dates

• First Submitted: November 7, 2022
• First Posted: February 9, 2023
• Study Start: March 12, 2025
• Primary Completion: June 30, 2025
• Study Completion: June 30, 2025
• Last Updated: December 22, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)