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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

Study Description
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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

Condition or disease Intervention/treatment Phase
Non Insulin Dependent Diabetes Dietary Supplement: Curcumin Dietary Supplement: Placebo Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 44 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: The Effect of Curcumin Supplementation on Anthropometric Indices, Insulin Resistance and Oxidative Stress in Patients With Type 2 Diabetes
Actual Study Start Date : July 2015
Actual Primary Completion Date : January 2016
Actual Study Completion Date : April 2016

Resource links provided by the National Library of Medicine

Drug Information available for: Curcumin

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: intervention
500 mg curcumin capsule
 Dietary Supplement: Curcumin
Placebo Comparator: control
placebo
 Dietary Supplement: Placebo


Outcome Measures
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Primary Outcome Measures :
  1. fasting blood sugar [ Time Frame: 10 weeks ]
  2. Insulin [ Time Frame: 10 week ]
  3. HbA1c [ Time Frame: 10 week ]
  4. Homeostatic Model Assessment of Insulin Resistance [ Time Frame: 10 week ]
  5. Change in pancreatic B-cell function [ Time Frame: 10 week ]

Secondary Outcome Measures :
  1. total capacity antioxidant [ Time Frame: 10 weeks ]
  2. Malondialdehyde [ Time Frame: 10 week ]
  3. Body mass index [ Time Frame: 10 week ]
  4. Waist circumference [ Time Frame: 10 week ]

Eligibility Criteria
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Ages Eligible for Study:   40 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02529982


Locations
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Iran, Islamic Republic of
NNFTRI clinic
Tehran, Iran, Islamic Republic of, 19435
Sponsors and Collaborators
National Nutrition and Food Technology Institute
More Information
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Responsible Party: Dr Azita Hekmatdoost, Principal Investigator, National Nutrition and Food Technology Institute
ClinicalTrials.gov Identifier: NCT02529982    
Other Study ID Numbers: 1370
First Posted: August 20, 2015    Key Record Dates
Last Update Posted: February 26, 2019
Last Verified: February 2019
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Curcumin
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
 Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action