- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02529982
Curcumin Supplementation and Patients With Type 2 Diabetes
February 24, 2019 updated by: Dr Azita Hekmatdoost, National Nutrition and Food Technology Institute
The Effect of Curcumin Supplementation on Anthropometric Indices, Insulin Resistance and Oxidative Stress in Patients With Type 2 Diabetes
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
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
44
Phase
- Not Applicable
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
-
-
-
Tehran, Iran, Islamic Republic of, 19435
- NNFTRI clinic
-
-
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
40 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
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: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: intervention
500 mg curcumin capsule
|
|
Placebo Comparator: control
placebo
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
fasting blood sugar
Time Frame: 10 weeks
|
10 weeks
|
Insulin
Time Frame: 10 week
|
10 week
|
HbA1c
Time Frame: 10 week
|
10 week
|
Homeostatic Model Assessment of Insulin Resistance
Time Frame: 10 week
|
10 week
|
Change in pancreatic B-cell function
Time Frame: 10 week
|
10 week
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
total capacity antioxidant
Time Frame: 10 weeks
|
10 weeks
|
Malondialdehyde
Time Frame: 10 week
|
10 week
|
Body mass index
Time Frame: 10 week
|
10 week
|
Waist circumference
Time Frame: 10 week
|
10 week
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
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 (Actual)
July 1, 2015
Primary Completion (Actual)
January 1, 2016
Study Completion (Actual)
April 1, 2016
Study Registration Dates
First Submitted
August 19, 2015
First Submitted That Met QC Criteria
August 19, 2015
First Posted (Estimate)
August 20, 2015
Study Record Updates
Last Update Posted (Actual)
February 26, 2019
Last Update Submitted That Met QC Criteria
February 24, 2019
Last Verified
February 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Glucose Metabolism Disorders
- Metabolic Diseases
- Endocrine System Diseases
- Diabetes Mellitus
- Diabetes Mellitus, Type 2
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Peripheral Nervous System Agents
- Enzyme Inhibitors
- Analgesics
- Sensory System Agents
- Anti-Inflammatory Agents, Non-Steroidal
- Analgesics, Non-Narcotic
- Anti-Inflammatory Agents
- Antirheumatic Agents
- Antineoplastic Agents
- Curcumin
Other Study ID Numbers
- 1370
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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