Clinical trial NCT02322268: RCT Evaluating Effects of Cosmos Caudatus (Ulam Raja) in T2DM Patients
Official title: Metabolomic Profiling on The Effect of Cosmos Caudatus (Ulam Raja) Supplementation in Patients With Type 2 Diabetes: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 2 Diabetes Mellitus
Obesity
Keywords: Type 2 Diabetes Mellitus
Cosmos Caudatus
Ulam Raja
Metabolomic profiling
antioxidant
Lead sponsor: Universiti Putra Malaysia
Sponsor class: OTHER
First posted: 2014-12-23
Enrollment: 101
Sex: ALL
Minimum age (years): 30
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Glycemic control
timeFrame: 1 month
Secondary outcomes:
measure: Liver profile
timeFrame: 1 month
measure: Renal profile
timeFrame: 1 month
measure: Blood pressure
timeFrame: 1 month
measure: Metabolite profile
timeFrame: 1 month
measure: Inflammatory marker
timeFrame: 1 month
measure: Lipid profile
timeFrame: 1 month
Other outcomes:
Locations:
city: Serdang
country: Malaysia
facility: Hospital Serdang
state: Selangor
Study officials:
affiliation: Universiti Putra Malaysia
name: Shi Hui Cheng
role: PRINCIPAL_INVESTIGATOR
References:
citation: Cheng SH, Ismail A, Anthony J, Ng OC, Hamid AA, Yusof BN. Effect of Cosmos caudatus (Ulam raja) supplementation in patients with type 2 diabetes: Study protocol for a randomized controlled trial. BMC Complement Altern Med. 2016 Feb 27;16:84. doi: 10.1186/s12906-016-1047-7.