Back to resultsKurCoSmart Effects on People With Type 2 DM
Primary Purpose
Diabetes Mellitus, Type 2, Insulin Resistance, Inflammation
Status
Not yet recruiting
Phase
Phase 1
Locations
Indonesia
Study Type
Interventional
Intervention
Curcumin and virgin coconut oil extract (KurCo Smart)
Sponsored by
About this trial
This is an interventional treatment trial for Diabetes Mellitus, Type 2 focused on measuring curcumin, coconut oil, diabetes mellitus
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
Sites / Locations
- UNS Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Control Group
Interventional Group
Arm Description
There is no additional intervention other than subject's standard diabetes treatment
This group will received additional supplementation of curcumin and virgin coconut oil aside from their standard treatment
Outcomes
Primary Outcome Measures
Blood glucose
Subject's fasting and prandial blood glucose
Inflammation degree
Subject's high sensitivity C-reactive protein level
insulin resistance
Subject's HOMA IR
HbA1c
Subject's glycated haemoglobin level
Secondary Outcome Measures
Body Mass Index
Subject's height and body weight
Blood Pressure
Subject's blood pressure
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05407467
Brief Title
KurCoSmart Effects on People With Type 2 DM
Official Title
KurCoSmart Effects on People With Type 2 DM: a Randomized, Open Trial
Study Type
Interventional
2. Study Status
Record Verification Date
June 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
June 2022 (Anticipated)
Primary Completion Date
August 2022 (Anticipated)
Study Completion Date
September 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universitas Sebelas Maret
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2, Insulin Resistance, Inflammation, Body Weight
Keywords
curcumin, coconut oil, diabetes mellitus
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
There is no additional intervention other than subject's standard diabetes treatment
Arm Title
Interventional Group
Arm Type
Experimental
Arm Description
This group will received additional supplementation of curcumin and virgin coconut oil aside from their standard treatment
Intervention Type
Dietary Supplement
Intervention Name(s)
Curcumin and virgin coconut oil extract (KurCo Smart)
Intervention Description
we give 2 tablets of curcumin and virgin coconut oil extract thrice a day for 30 days and evaluate the result
Primary Outcome Measure Information:
Title
Blood glucose
Description
Subject's fasting and prandial blood glucose
Time Frame
Change of Blood glucose at 1 months
Title
Inflammation degree
Description
Subject's high sensitivity C-reactive protein level
Time Frame
Change of hs-CRP at 1 Months
Title
insulin resistance
Description
Subject's HOMA IR
Time Frame
Change of HOMA IR at 1 Months
Title
HbA1c
Description
Subject's glycated haemoglobin level
Time Frame
Change of HbA1C at 1 Months
Secondary Outcome Measure Information:
Title
Body Mass Index
Description
Subject's height and body weight
Time Frame
Change of BMI at 1 Months
Title
Blood Pressure
Description
Subject's blood pressure
Time Frame
Change fof blood prssure at 1 Months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nurhasan Agung Prabowo, MD
Phone
6282328010430
Email
dr.Nurhasan21@staff.uns.ac.id
Facility Information:
Facility Name
UNS Hospital
City
Sukoharjo
State/Province
Central Java
ZIP/Postal Code
57161
Country
Indonesia
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Desy Puspa Putri, Master
Phone
+6281283284827
Email
desypuspa@staff.uns.ac.id
First Name & Middle Initial & Last Name & Degree
Nurhasan Agung Prabowo, Master
First Name & Middle Initial & Last Name & Degree
Yulia Sari, Doctor
First Name & Middle Initial & Last Name & Degree
Desy Puspa Putri, Master
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Individual participant data will be restricted for this study purpose only
Learn more about this trial
KurCoSmart Effects on People With Type 2 DM
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