RCT Evaluating Effects of Cosmos Caudatus (Ulam Raja) in T2DM Patients

Obesity Clinical Trial

Official title:

Metabolomic Profiling on The Effect of Cosmos Caudatus (Ulam Raja) Supplementation in Patients With Type 2 Diabetes: A Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02322268
• Other study ID #: 6370700
• Status: Completed
• Phase: N/A
• First received: December 20, 2014
• Last updated: November 30, 2015
• Start date: August 2014
• Est. completion date: November 2015

Study information

• Verified date: November 2015
• Source: Universiti Putra Malaysia
• Contact: n/a
• Is FDA regulated: No
• Health authority: Malaysia: National Medical Research RegisterMalaysia: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine whether Cosmos caudatus is effective as an adjuvant therapy for type 2 Diabetes Mellitus.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 101
• Est. completion date: November 2015
• Est. primary completion date: November 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Obesity
• Type 2 Diabetes Mellitus

Intervention

Dietary Supplement:
• Cosmos Caudatus
15g of Cosmos caudatus consumed with lunch or dinner

Locations

Country	Name	City	State
Malaysia	Hospital Serdang	Serdang	Selangor

Sponsors (1)

Lead Sponsor	Collaborator
Universiti Putra Malaysia

Country where clinical trial is conducted

Malaysia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Glycemic control		1 month	No
Secondary	Liver profile		1 month	Yes
Secondary	Renal profile		1 month	Yes
Secondary	Blood pressure		1 month	Yes
Secondary	Metabolite profile		1 month	No
Secondary	Inflammatory marker		1 month	No
Secondary	Lipid profile		1 month	No

External Links

•   Medlineplus
•   Type 2 Diabetes