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Trial record 87 of 167 for:    curcumin

Curcumin Supplementation and Patients With Type 2 Diabetes

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02529982
Recruitment Status : Completed
First Posted : August 20, 2015
Last Update Posted : February 26, 2019
Sponsor:
Information provided by (Responsible Party):
Dr Azita Hekmatdoost, National Nutrition and Food Technology Institute

Tracking Information
First Submitted Date  ICMJE August 19, 2015
First Posted Date  ICMJE August 20, 2015
Last Update Posted Date February 26, 2019
Actual Study Start Date  ICMJE July 2015
Actual Primary Completion Date January 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 24, 2019)
  • fasting blood sugar [ Time Frame: 10 weeks ]
  • Insulin [ Time Frame: 10 week ]
  • HbA1c [ Time Frame: 10 week ]
  • Homeostatic Model Assessment of Insulin Resistance [ Time Frame: 10 week ]
  • Change in pancreatic B-cell function [ Time Frame: 10 week ]
Original Primary Outcome Measures  ICMJE
 (submitted: August 19, 2015)
fasting blood sugar [ Time Frame: 12 weeks ]
Change History Complete list of historical versions of study NCT02529982 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: February 24, 2019)
  • total capacity antioxidant [ Time Frame: 10 weeks ]
  • Malondialdehyde [ Time Frame: 10 week ]
  • Body mass index [ Time Frame: 10 week ]
  • Waist circumference [ Time Frame: 10 week ]
Original Secondary Outcome Measures  ICMJE
 (submitted: August 19, 2015)
total capacity antioxidant [ Time Frame: 12 weeks ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Curcumin Supplementation and Patients With Type 2 Diabetes
Official Title  ICMJE The Effect of Curcumin Supplementation on Anthropometric Indices, Insulin Resistance and Oxidative Stress in Patients With Type 2 Diabetes
Brief Summary Diabetes mellitus is the most common endocrine disorder, causes many complications such as micro- and macro-vascular diseases. Various kinds of antidiabetic drugs have been developed, but most of them have side effects. Recently, the use of natural plant products has gained more attention among scientists in order to prevent diabetic vascular complications. Curcumin is a natural yellow product derived from the turmeric rhizome which has shown to be non-toxic and exhibits various bio¬logical activities such as anti-oxidant, anti-inflammatory, anti-carcinogenic, and anti-diabetic effects. Curcumin is effective in reducing glycemic index and hyperlipidemia in rodent models and is relatively inexpensive and safe. Most of the studies conducted on animal model, and just a few of them are on human model. The present study was planned to evaluate the effects of curcumin supplementation The effect of curcumin supplementation on anthropometric indices, insulin resistance and oxidative stress in patients with type 2 diabetes
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Non Insulin Dependent Diabetes
Intervention  ICMJE
  • Dietary Supplement: Curcumin
  • Dietary Supplement: Placebo
Study Arms  ICMJE
  • Active Comparator: intervention
    500 mg curcumin capsule
    Intervention: Dietary Supplement: Curcumin
  • Placebo Comparator: control
    placebo
    Intervention: Dietary Supplement: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 24, 2019)
44
Original Estimated Enrollment  ICMJE
 (submitted: August 19, 2015)
50
Actual Study Completion Date  ICMJE April 2016
Actual Primary Completion Date January 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

insulin Inclusion Criteria:

  • a) Tendency to participate b) Age range of 40-65 c) Suffering from diabetes type 2 ( between 1 to 10 yeares) d) BMI 18/5-30 e) Patients with diabetes who administer oral hypoglycemic agents and do not use

Exclusion Criteria:

  • a) patients with liver diseases b) patients with kidney diseases c) patients with inflammatory diseases d) patients with liver diseases e) Administering herbal agents f) Administering multivitamins and minerals in past 3 months
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 40 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Iran, Islamic Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02529982
Other Study ID Numbers  ICMJE 1370
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Dr Azita Hekmatdoost, National Nutrition and Food Technology Institute
Study Sponsor  ICMJE National Nutrition and Food Technology Institute
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account National Nutrition and Food Technology Institute
Verification Date February 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP