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NCT Number: NCT06970834

Explore the Effect of Bitter Melon Peptides on Glycemic Control and Metabolic Indicators in Diabetic Patients

The goal of this clinical trial is to learn the potential of bitter melon peptides in stabilizing blood glucose in diabetic adults. It will also learn about the effects of bitter melon peptides on metabolic parameters. The main questions it aims to answer are:

* the regulatory effects of bitter melon peptides on glycemic variability * impact on glycemic and metabolic indicators Researchers will compare bitter melon peptides to a placebo (a look-alike capsule that contains Microcrystalline Cellulose) to see if bitter melon peptides works to stabilizing blood glucose.

Participants will:

* Take bitter melon peptides or a placebo every day for 12 weeks * Visit the clinic on day 0, day 7, day 28 and day 84 for checkups and tests * Glucose levels were monitored continuously by CGMs in the first 7 days and fasting blood samples were drawn at first visit (day0), third visit (day 28) and fourth visits (day 84)

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Key information

Conditions

Diabetes Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Participants were diagnosed with type 2 DM based on criteria recommended by the American Diabetes Association and required to have fasting plasma glucose of ≥126 mg/dl or an HbA1c of

≥ 6.5%, as measured on two separate occasions

Exclusion criteria

cancer, active liver disease, current pregnancy , acute illness and autoimmune thyroid disease.

Treatment and study plan

bitter melon peptides

Dietary Supplement

Momordica charantia extract

Primary outcomes

  1. glycemic variability

    Time frame: From enrollment (day0) to day7

    mean amplitude of glucose excursions and coefficient of variation, using CGM

Secondary outcomes

  1. glycemic control

    Time frame: From enrollment (day0) to the end (day84)

    Glycated hemoglobulin A1C

Other outcomes

  1. metabolic indicator

    Time frame: From enrollment (day0) to the end (day84)

    C-peptide

Study contacts

Contact information is provided by the study sponsor or research team.

PEI-YUNG LIAO, M.D.

CONTACT

[email protected]

+88647238595

Sponsors and collaborators

Lead sponsor

Changhua Christian Hospital

Other

Collaborators

  • China Medical University, Taiwan

Registry information

Official study title

Using Continuous Glucose Monitoring Tools to Explore the Effect of Bitter Melon Peptides on Glycemic Control and Metabolic Indicators in Diabetic Patients

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
May 14, 2025
Registry last updated
May 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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