KurCoSmart Effects on People With Type 2 DM

Phase 1

• Conditions: Inflammation; Diabetes Mellitus, Type 2; Insulin Resistance; Body Weight
• Interventions: Dietary Supplement: Curcumin and virgin coconut oil extract (KurCo Smart)

• Registration Number: NCT05407467
• Lead Sponsor: Universitas Sebelas Maret

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

Study Timeline

• Study First Submitted: 2022-05-18
• Status Verified: 2022-06
• Study Start: 2022-06
• Study First Submitted QC: 2022-06-01
• Last Update Submitted: 2022-06-01
• Study First Posted: 2022-06-07
• Last Update Posted: 2022-06-07
• Primary Completion: 2022-08
• Study Completion: 2022-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Interventional Group	Curcumin and virgin coconut oil extract (KurCo Smart)	This group will received additional supplementation of curcumin and virgin coconut oil aside from their standard treatment

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Body Mass Index	Change of BMI at 1 Months	Subject's height and body weight
Blood Pressure	Change fof blood prssure at 1 Months	Subject's blood pressure

Trial Locations

Locations (1)

UNS Hospital; 🇮🇩 Sukoharjo, Central Java, Indonesia