Diabetes
Conditions
Keywords
bitter melon peptides
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)
Interventions
DIETARY_SUPPLEMENTbitter melon peptides
Momordica charantia extract
Sponsors
China Medical University, Taiwan
Changhua Christian Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Intervention model description
A total of 160 diabetic patients on Metformin monotherapy will be recruited and randomized into either the bitter melon peptide group or the placebo group for a 12-week clinical intervention
Eligibility
Sex/Gender
ALL
Age
20 Years to 80 Years
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| glycemic variability | From enrollment (day0) to day7 | mean amplitude of glucose excursions and coefficient of variation, using CGM |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| glycemic control | From enrollment (day0) to the end (day84) | Glycated hemoglobulin A1C |
Other
| Measure | Time frame | Description |
|---|---|---|
| metabolic indicator | From enrollment (day0) to the end (day84) | C-peptide |
Contacts
Primary ContactPEI-YUNG LIAO, M.D.
Outcome results
None listed