Using Continuous Glucose Monitoring Tools to Explore the Effect of Bitter Melon Peptides on Glycemic Control and Metabolic Indicators in Diabetic Patients
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Changhua Christian Hospital
- Enrollment
- 160
- Primary Endpoint
- glycemic variability
Study Overview
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)
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Care Provider, Investigator)
Eligibility Criteria
- Ages
- 20 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
bitter melon peptides
Bitter melon peptide contains various active substances such as bitter melon saponins and bitter melon polysaccharides.
Intervention: bitter melon peptides (Dietary Supplement)
Placebo group
The placebo capsule containing microcrystalline cellulose. The placebo is identical in appearance, color, and dosage schedule to the intervention product, but does not contain any active ingredients.
Intervention: bitter melon peptides (Dietary Supplement)
Outcomes
Primary Outcomes
glycemic variability
Time Frame: From enrollment (day0) to day7
mean amplitude of glucose excursions and coefficient of variation, using CGM
Secondary Outcomes
- glycemic control(From enrollment (day0) to the end (day84))
Investigators
PEI-YUNG LIAO
Chief of Division of Endocrinology and Metabolism, Department of Internal Medicine
Changhua Christian Hospital