Diabetes Mellitus Type 2
Conditions
Keywords
Propolis, Diabetes Mellitus Type 2, Low Density Lipoprotein, High Density Lipoprotein
Brief summary
The goal of this clinical trial is to learn if propolis administration works to change the level of Low Density Lipoprotein (LDL) and High Density Lipoprotein cholesterol (HDL) in diabetic type 2 patients. The main questions it aims to answer are: \- Is giving 1 drops/ 10kg/ times, twice daily for 8 weeks will change the level of LDL and HDL level in diabetic type 2 patients compared to placebo? Researchers will compare propolis to a placebo (a look-alike substance that contains no drug) to see if propolis works to change LDL and HDL cholesterol level. Participants will: * Take propolis or a placebo, 2 times daily with given dose (1 drops/10 kg/times) every day for 2 months * Visit the sub-district health centre once every 2 weeks for checkups * Get their blood checked before and after intervention
Detailed description
Subject allocation into groups will be made by third party to ensure masking/ blinding protocol. Data that will be taken from participants : * Private information * Medication history (for type 2 Diabetes Mellitus) * Food intake (calories, fats, carbohydrate, protein, and flavonoid intake) * Physical activity status
Interventions
DRUGPropolis drops
The intervention given is propolis drops that are approved by Indonesian Food and Drug Authority
OTHERPlacebo
The given placebo are look-alike substance with no effect
Sponsors
Indonesia University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
The participants will be randomly allocated into two groups that will recieve either propolis or plasebo. The study model is double-blinded trial. The participants are patients undergoing treatment for type 2 diabetes in multiple sub-dictrict health centre in Central Jakarta and will be screened based on inclusion and exclusion criteria.
Eligibility
Sex/Gender
ALL
Age
35 Years to 59 Years
Healthy volunteers
No
Inclusion criteria
* Controlled Diabetes Mellitus type 2 with HbA1c \<7.5% * BMI 23-35 kg/m2 * On anti-cholesterol therapy
Exclusion criteria
* Using injection therapy (insulin or GLP-1 RA) * History of bees product allergy * Active smoker * Consuming alcohol * Altered liver (ALT\>35 IU/L) and kidney (eGFR\<90 mL/min) function * Pregnant and breastfeeding women * History of cardiovascular disease (heart attack, stroke)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Low Density Lipoprotein | 8 weeks | LDL level will be measured twice, before and after intervention |
| High Density Lipoprotein | 8 weeks | HDL will be measured twice, before and after intervention |
Countries
Indonesia
Contacts
Primary ContactDwirini R Gunarti, Biomed Science
Backup ContactWiryani Sentosa, MD
Outcome results
None listed