Explore the Effect of Bitter Melon Peptides on Glycemic Control and Metabolic Indicators in Diabetic Patients
- Conditions
- Diabetes
- Registration Number
- NCT06970834
- Lead Sponsor
- Changhua Christian Hospital
- Brief Summary
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)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 160
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
cancer, active liver disease, current pregnancy , acute illness and autoimmune thyroid disease.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method glycemic variability From enrollment (day0) to day7 mean amplitude of glucose excursions and coefficient of variation, using CGM
- Secondary Outcome Measures
Name Time Method glycemic control From enrollment (day0) to the end (day84) Glycated hemoglobulin A1C