KurCoSmart Effects on People With Type 2 DM

Study Overview
=================
Brief Summary
-----------------
The investigators aim to evaluate the effect of curcumin and virgin coconut oil extract supplementation on people with type 2 DM, including blood glucose, HbA1c levels, inflammation, body weight and insulin resistance evaluation

Detailed Description
-----------------
The investigators give Kurcosmart supplementation aside from diabetes standard treatment to evaluate its benefits on people with type 2 DM, considering its effect on controlling fasting and prandial blood glucose, reducing HbA1c level, controlling inflammation degree; and repairing insulin resistance

Official Title
-----------------
KurCoSmart Effects on People With Type 2 DM: a Randomized, Open Trial

Conditions
-----------------
Diabetes Mellitus, Type 2, Insulin Resistance, Inflammation, Body Weight

Intervention / Treatment
-----------------
* Dietary Supplement: Curcumin and virgin coconut oil extract (KurCo Smart)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Confirmed Type 2 DM Signing consent form Exclusion Criteria: Pregnant or breastfeeding Multiple organ failure History of hypersensitivity reaction to curcumin and virgin coconut oil Cancer, renal insufficiency, hematological disease, acute heart failure, chronic liver disease

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control Group<br>There is no additional intervention other than subject's standard diabetes treatment | |
| Experimental: Interventional Group<br>This group will received additional supplementation of curcumin and virgin coconut oil aside from their standard treatment | Dietary Supplement: Curcumin and virgin coconut oil extract (KurCo Smart)<br>* we give 2 tablets of curcumin and virgin coconut oil extract thrice a day for 30 days and evaluate the result<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood glucose | Subject's fasting and prandial blood glucose | Change of Blood glucose at 1 months | 
| Inflammation degree | Subject's high sensitivity C-reactive protein level | Change of hs-CRP at 1 Months | 
| insulin resistance | Subject's HOMA IR | Change of HOMA IR at 1 Months | 
| HbA1c | Subject's glycated haemoglobin level | Change of HbA1C at 1 Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body Mass Index | Subject's height and body weight | Change of BMI at 1 Months | 
| Blood Pressure | Subject's blood pressure | Change fof blood prssure at 1 Months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
curcumin, coconut oil, diabetes mellitus