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

Last updated: April 28, 2025
Sponsor: Yu Chen
Overall Status: Active - Recruiting

Phase

N/A

Condition

Diabetes (Pediatric)

Diabetes And Hypertension

Diabetes Prevention

Treatment

Berberine

AKK Placebo

Akkermansia muciniphila

Clinical Study ID

NCT05720299
ZY19-202201
  • Ages 18-65
  • All Genders

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Aged 18-65

  2. Overweight/obesity (24.0≤BMI≤40.0 kg/m^2)

  3. 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%

  4. Fertile subjects (including male and female subjects) agreed to take effectivecontraceptive measures that the investigator accepted during and within 3 monthsafter the trial (e.g. intrauterine device or a condom); the fertile female subjectswith serum human chorionic gonadotropin test negative results within 7 days beforethe investigational product administration; Infertile female must be surgicallyinfertile or at least 1 year after menopause.

  5. Subjects should understand the nature, significance, potential benefits,inconvenience and risks of the study before the trial begins, fully understand andvoluntarily sign the informed consent.

Exclusion

Exclusion Criteria:

  1. Subjects who diagnosed with diabetes mellitus, medical obesity (excluding those whohave been off medication for more than 1 year), or other secondary diabetes mellitus (e.g., Cushing's syndrome, thyroid dysfunction, or acromegaly);

  2. Subjects who has undergone bariatric surgery;

  3. Subjects who has acute or chronic progressive or unstable disease, liver and kidneyinsufficiency, serious cardiovascular and cerebrovascular diseases;

3.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.

Study Design

Total Participants: 90
Treatment Group(s): 4
Primary Treatment: Berberine
Phase:
Study Start date:
March 12, 2025
Estimated Completion Date:
February 10, 2026

Connect with a study center

  • The Seventh Affiliated Hospital of Southern Medical University

    Foshan, Guangdong 514500
    China

    Active - Recruiting

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