Curcumin for Type 2 Diabetic Patients

January 19, 2010 updated by: Srinakharinwirot University

Antiatherogenic and Antimetabolic Effect of Curcumin in Type 2 Diabetic Patients

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

200

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Thailand
    • Nakornnayok
      • Ongkarak, Nakornnayok, Thailand, 26120
        • Recruiting
        • HRH Princess Maha Chakri Sirindhorn Medical Center
        • Contact:
          • Somlak Chuengsamarn, Medical Doctor
          • Phone Number: +6637-39-5085
          • Email: somlukc@swu.ac.th
        • Principal Investigator:
          • Somlak Chuengsamarn, Medical Doctor

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

35 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: curcumin
Curcumin capsule contains 250 mg curcuminoids, 2 capsule per time, 3 times a day for 12 months
Other Names:
  • Manufactured by Government Pharmaceutical Organization, Thailand
Experimental: Curcumin
Drug: curcumin
Curcumin capsule contains 250 mg curcuminoids, 2 capsule per time, 3 times a day for 12 months
Other Names:
  • Manufactured by Government Pharmaceutical Organization, Thailand

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
to determine the effectiveness of curcumin on reduction of atherosclerotic events and risks in Type 2 diabetic patients
Time Frame: 12 months
12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
To examine the effectiveness of curcumin on the reduction of blood sugar, glycosylated hemoglobin (HBA1c), lipid profile, and insulin resistance
Time Frame: 12 months
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Srinakharinwirot University

Collaborators

Ministry of Health, Thailand

Investigators

  • Principal Investigator: Somlak Chuengsamarn, Medical Doctor, Srinakarinwirot University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2009

Primary Completion (Anticipated)

February 1, 2010

Study Completion (Anticipated)

March 1, 2010

Study Registration Dates

First Submitted

January 19, 2010

First Submitted That Met QC Criteria

January 19, 2010

First Posted (Estimate)

January 20, 2010

Study Record Updates

Last Update Posted (Estimate)

January 20, 2010

Last Update Submitted That Met QC Criteria

January 19, 2010

Last Verified

August 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SWUEC30/2550

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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