Curcumin Therapy in Patients With Impaired Glucose Tolerance and Insulin Resistance

January 19, 2010 updated by: Srinakharinwirot University

Antiatherogenic and Antimetabolic Effect of Curcumin Therapy in the Prevention and Delay of Type 2 Diabetic in Patients With Impaired Glucose Tolerance and Insulin Resistance

The incidence rate of type 2 diabetes in Thai populations is high and increasing every year. Cardiovascular disease is the main complication of this disease, which has been defined as an important cause of death among Diabetic patients. This disease is now becoming a major health problem and causes a great economic loss to the country. Evidence shows that Curcumin, Thai herbal medicine, has the effectiveness of prevention and delay of type 2 diabetes. However, there is no scientific study that aims to prove the efficacy of this herb particularly for prevention and delay the disease in Patients with impaired glucose tolerance (pre-diabetes) 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 Contact

  • Name: Somlak Chuengsamarn, Medical Doctor
  • Phone Number: 11001 +663739-5085
  • Email: somlukc@swu.ac.th

Study Locations

  • Thailand
    • Nakornnayok
      • Ongkarak, Nakornnayok, Thailand, 26120
        • Recruiting
        • HRH Princess Maha Chakri Sirindhorn Medical Center
        • Principal Investigator:
          • Somlak Chuengsamarn, Medical Doctor
        • Contact:
          • Somlak Chuengsamarn, Medical Doctor
          • Phone Number: 11001 +663739-5085
          • Email: somlukc@swu.ac.th

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:

  • Patients aged 35 years or older with an abnormal fasting plasma glucose (100-125 mg/dl) or with insulin resistance (140-199 mg/dl) by using 75 mg of glucose OGTT.

Exclusion Criteria:

  • Have been diagnosed with diabetes by the results of FPG >/=126 mg/dl
  • Present with secondary peripheral arterial disease (PAD)
  • Present with cardiovascular diseases such as coronary arterial disease and cerebrovascular disease
  • Receive anticoagulant drugs that have an effect on the measurement of pulse wave velocity (PWV)
  • Receive antihypertensive or lipid-lowering drugs (ARB, ACEI, fenofibrate, atorvastatin, rosuvastatin, fluvastatin) that have an effect on the measurement of C-reactive protein (CRP)
  • Present with kidney failure (serum creatinine > 2.0 mg/dl) or in the process of renal dialysis
  • Present with hepatitis (ALT level >/= 3 times the upper limit)
  • Receive any herbal medications or curcumin
  • Present with high blood sugar from other causes apart from type 2 diabetes such as receiving steroid drugs, cancer or pancreatic cyst
  • Present with infection or inflammation that have effect on the level of CRP
  • Pregnancy or breastfeeding
  • Have a history of gall bladder diseases or removal

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: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Placebo
Experimental: Curcumin
curcumin capsule contains 250 mg curcuminoiods, 3 capsules per time, 2 times a day before meal for 12 months
Drug: Curcumin
curcumin capsule contains 250 mg curcuminoiods, 3 capsules per time, 2 times a day before meal for 12 months
Other Names:
  • Curcumin capsules are manufactured by Government Pharmaceutical Organization, Thailand

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To examine the efficacy of curcumin on the delay of degenerative beta-cells in pancrease for protection of Type 2 Diabetes in patients with impaired glucose tolerance (Pre-diabetes)
Time Frame: 12 months
12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
To examine the efficacy of curcumin on the reduction of blood sugar level, lipid profile, insulin resistance status and oxidative stress status in Pre-diabetes patients
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

August 1, 2009

Primary Completion (Anticipated)

March 1, 2010

Study Completion (Anticipated)

April 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

March 1, 2009

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SWUEC9/2552

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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