Curcumin for Type 2 Diabetic Patients

Sponsor
Srinakharinwirot University (Other)
Overall Status
Unknown status
CT.gov ID
NCT01052597
Collaborator
Ministry of Health, Thailand (Other)
200
1
2
8
25.1

Study Details

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.

Condition or Disease Intervention/Treatment Phase
Phase 4

Study Design

Study Type:
Interventional
Anticipated Enrollment :
200 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Investigator)
Primary Purpose:
Treatment
Official Title:
Antiatherogenic and Antimetabolic Effect of Curcumin in Type 2 Diabetic Patients
Study Start Date :
Jul 1, 2009
Anticipated Primary Completion Date :
Feb 1, 2010
Anticipated Study Completion Date :
Mar 1, 2010

Arms and Interventions

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
  • Outcome Measures

    Primary Outcome Measures

    1. to determine the effectiveness of curcumin on reduction of atherosclerotic events and risks in Type 2 diabetic patients [12 months]

    Secondary Outcome Measures

    1. To examine the effectiveness of curcumin on the reduction of blood sugar, glycosylated hemoglobin (HBA1c), lipid profile, and insulin resistance [12 months]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    35 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 HRH Princess Maha Chakri Sirindhorn Medical Center Ongkarak Nakornnayok Thailand 26120

    Sponsors and Collaborators

    • Srinakharinwirot University
    • Ministry of Health, Thailand

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT01052597
    Other Study ID Numbers:
    • SWUEC30/2550
    First Posted:
    Jan 20, 2010
    Last Update Posted:
    Jan 20, 2010
    Last Verified:
    Aug 1, 2007

    Study Results

    No Results Posted as of Jan 20, 2010