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Not yet recruiting NCT06970834

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

No phase Interventional Diabetes

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: bitter melon peptides.
Who it may be relevant to
Registry conditions: Diabetes. Basic parameters: 20 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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)

Interventions

  • Dietary supplement bitter melon peptides
    Momordica charantia extract

Primary outcome measures

  • glycemic variability [Time frame: From enrollment (day0) to day7]
Secondary outcome measures (1)
  • glycemic control [Time frame: From enrollment (day0) to the end (day84)]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Triple blind
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT06970834 · CCH IRB 250121

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗