Obesity, Type 2 Diabetes Mellitus
Conditions
Keywords
Type 2 Diabetes Mellitus, Cosmos Caudatus, Ulam Raja, Metabolomic profiling, antioxidant
Brief summary
The purpose of this study is to determine whether Cosmos caudatus is effective as an adjuvant therapy for type 2 Diabetes Mellitus.
Detailed description
Background: Cosmos caudatus (C. caudatus) ethanol extract has been reported to have extraordinary high antioxidant capacity compared to other plants. Furthermore it has been shown to reduce the plasma blood glucose and lipid profile significantly in an animal model. However, no study has been reported on its effectiveness in human. Therefore, we plan to conduct a randomized controlled trial to evaluate the effectiveness and safety of C. caudatus on glycemic status, oxidative stress markers, inflammatory markers, lipid profile in patients with type 2 diabetes. Besides, metabolomics approach will be carried out to compare the metabolite changes between diabetic C. caudatus treated and control patients. Methods: A single-center randomized, controlled, two-arm parallel design clinical trial will be carried out in Malaysia. This study enrol 92 patients diagnosed with type 2 diabetes. Diabetic patients who meet eligibility criteria will be randomly allocated to two groups, which are C. caudatus treatment group and control group. Both groups will be compared on the primary and secondary outcomes at baseline, 4, 8, and 12 weeks. The serum and urine metabolome of both groups will be examined using proton NMR spectroscopy. Discussion: The study will provide insights into the potential beneficial effect of C. caudatus in type 2 diabetic patients. In addition, the therapeutic effect of C. caudatus towards type 2 diabetes will reflect as a change of metabolite profile in urine and serum.
Interventions
DIETARY_SUPPLEMENTCosmos Caudatus
15g of Cosmos caudatus consumed with lunch or dinner
Sponsors
Universiti Putra Malaysia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
30 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1. Confirmed type 2 diabetes with at least 6 months diagnosis 2. BMI between 18.5-40 kg/ m2 3. Able to comply to the study protocol 4. They are treated with stabilized dose of oral diabetic agents
Exclusion criteria
1. Pregnant and lactating 2. Have any gastrointestinal disorder that interferes the bowel function, severe hepatic or renal disease (dialysis), an infection that requires antibiotics within three weeks 3. They are currently on insulin regimen. 4. Individuals on the following drugs which will possibly have herb-drug interaction: anticoagulant such as warfarin and aspirin, corticosteroids (Prednisolone), fluoroquinolones (ciprofloxacin, levofloxacin), doxorubicin, cisplatin, cyclosporine, and digoxin
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Glycemic control | 1 month |
Secondary
| Measure | Time frame |
|---|---|
| Renal profile | 1 month |
| Blood pressure | 1 month |
| Liver profile | 1 month |
| Inflammatory marker | 1 month |
| Lipid profile | 1 month |
| Metabolite profile | 1 month |
Countries
Malaysia
Outcome results
None listed