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Curcumin for Type 2 Diabetic Patients

Primary Purpose

Type 2 Diabetes Mellitus, Cardiovascular Abnormalities

Status

Unknown status

Phase

Phase 4

Locations

Thailand

Study Type

Interventional

Intervention

curcumin

About this trial

This is an interventional treatment trial for Type 2 Diabetes Mellitus focused on measuring Type 2 diabetes, Metabolic syndrome, cardiovascular risk

Eligibility Criteria

35 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Diabetic patients aged 35 years or older and did not use insulin during the first 5 years of treatment after being diagnosed (with or without symptoms listed in the following inclusion criteria)
Patient with hyperlipidemia (Cholesterol ≥ 200 mg/dl, TG ≥ 150 mg/dl, LDL ≥ 100 mg/dl and HDL ≥ 35 mg/dl)
Patient with hypertension (Blood pressure ≥ 130/85 mmHg or take hypertensive drugs)
Obesity (BMI ≥ 25)

Exclusion Criteria:

Current diagnosis of secondary peripheral arterial disease (PAD) (except listed in the inclusion criteria item 1-4)
Current diagnosis of cardiovascular disease, i.e., coronary arterial disease and cerebrovascular disease
Current diagnosis of end stage renal function with serum creatinine > 2.0 mg/dl or on renal dialysis
Current diagnosis of cirrhosis with ALT ≥ 3 times of normal range

Sites / Locations

HRH Princess Maha Chakri Sirindhorn Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo

Curcumin

Arm Description

Outcomes

Primary Outcome Measures

to determine the effectiveness of curcumin on reduction of atherosclerotic events and risks in Type 2 diabetic patients

Secondary Outcome Measures

To examine the effectiveness of curcumin on the reduction of blood sugar, glycosylated hemoglobin (HBA1c), lipid profile, and insulin resistance

Full Information

NCT ID

NCT01052597

First Posted

January 19, 2010

Last Updated

January 19, 2010

Sponsor

Srinakharinwirot University

Collaborators

Ministry of Health, Thailand

1. Study Identification

Unique Protocol Identification Number

NCT01052597

Brief Title

Curcumin for Type 2 Diabetic Patients

Official Title

Antiatherogenic and Antimetabolic Effect of Curcumin in Type 2 Diabetic Patients

Study Type

Interventional

2. Study Status

Record Verification Date

August 2007

Overall Recruitment Status

Unknown status

Study Start Date

July 2009 (undefined)

Primary Completion Date

February 2010 (Anticipated)

Study Completion Date

March 2010 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor

Srinakharinwirot University

Collaborators

Ministry of Health, Thailand

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

There are evidence that there is an association between insulin resistance and prolonged hyperinsulinemia or hyperglycemia in Type 2 diabetic patients. This will trigger oxidative stress system via reactive oxygen species (ROS) and lead to a high level of Nitric oxide. This can contribute to a significant change in blood vessel and could end up with the complications from cardiovascular disease and increased mortality rate of type 2 diabetic patients. The purpose of the present study was to examine the effectiveness of the curcumin in type 2 diabetic patients on the reduction of atherosclerosis events by examining pulse-wave velocity (PWV) and plasma high-sensitivity C-reactive protein (CRP) test and on blood sugar lowering, glycosylated hemoglobin (HBA1c), lipid profile, and insulin resistance.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Type 2 Diabetes Mellitus, Cardiovascular Abnormalities

Keywords

Type 2 diabetes, Metabolic syndrome, cardiovascular risk

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

Investigator

Allocation

Randomized

Enrollment

200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Title

Curcumin

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

curcumin

Other Intervention Name(s)

Manufactured by Government Pharmaceutical Organization, Thailand

Intervention Description

Curcumin capsule contains 250 mg curcuminoids, 2 capsule per time, 3 times a day for 12 months

Primary Outcome Measure Information:

Title

to determine the effectiveness of curcumin on reduction of atherosclerotic events and risks in Type 2 diabetic patients

Time Frame

12 months

Secondary Outcome Measure Information:

Title

To examine the effectiveness of curcumin on the reduction of blood sugar, glycosylated hemoglobin (HBA1c), lipid profile, and insulin resistance

Time Frame

12 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

35 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Diabetic patients aged 35 years or older and did not use insulin during the first 5 years of treatment after being diagnosed (with or without symptoms listed in the following inclusion criteria) Patient with hyperlipidemia (Cholesterol ≥ 200 mg/dl, TG ≥ 150 mg/dl, LDL ≥ 100 mg/dl and HDL ≥ 35 mg/dl) Patient with hypertension (Blood pressure ≥ 130/85 mmHg or take hypertensive drugs) Obesity (BMI ≥ 25) Exclusion Criteria: Current diagnosis of secondary peripheral arterial disease (PAD) (except listed in the inclusion criteria item 1-4) Current diagnosis of cardiovascular disease, i.e., coronary arterial disease and cerebrovascular disease Current diagnosis of end stage renal function with serum creatinine > 2.0 mg/dl or on renal dialysis Current diagnosis of cirrhosis with ALT ≥ 3 times of normal range

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Somlak Chuengsamarn, Medical Doctor

Phone

+6637-39-5085

somlukc@swu.ac.th

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Somlak Chuengsamarn, Medical Doctor

Organizational Affiliation

Srinakarinwirot University

Official's Role

Principal Investigator

Facility Information:

Facility Name

HRH Princess Maha Chakri Sirindhorn Medical Center

City

Ongkarak

State/Province

Nakornnayok

ZIP/Postal Code

26120

Country

Thailand

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Somlak Chuengsamarn, Medical Doctor

Phone

+6637-39-5085

somlukc@swu.ac.th

First Name & Middle Initial & Last Name & Degree

Somlak Chuengsamarn, Medical Doctor

12. IPD Sharing Statement

Citations:

PubMed Identifier

24445038

Citation

Chuengsamarn S, Rattanamongkolgul S, Phonrat B, Tungtrongchitr R, Jirawatnotai S. Reduction of atherogenic risk in patients with type 2 diabetes by curcuminoid extract: a randomized controlled trial. J Nutr Biochem. 2014 Feb;25(2):144-50. doi: 10.1016/j.jnutbio.2013.09.013. Epub 2013 Nov 6.

Results Reference

derived

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Curcumin for Type 2 Diabetic Patients

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