Back to resultsCurcumin Supplementation and Patients With Type 2 Diabetes
Primary Purpose
Non Insulin Dependent Diabetes
Status
Completed
Phase
Not Applicable
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
Curcumin
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Non Insulin Dependent Diabetes
Eligibility 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
Sites / Locations
- NNFTRI clinic
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
intervention
control
Arm Description
500 mg curcumin capsule
placebo
Outcomes
Primary Outcome Measures
fasting blood sugar
Insulin
HbA1c
Homeostatic Model Assessment of Insulin Resistance
Change in pancreatic B-cell function
Secondary Outcome Measures
total capacity antioxidant
Malondialdehyde
Body mass index
Waist circumference
Full Information
NCT ID
NCT02529982
First Posted
August 19, 2015
Last Updated
February 24, 2019
Sponsor
National Nutrition and Food Technology Institute
1. Study Identification
Unique Protocol Identification Number
NCT02529982
Brief Title
Curcumin Supplementation and Patients With Type 2 Diabetes
Official Title
The Effect of Curcumin Supplementation on Anthropometric Indices, Insulin Resistance and Oxidative Stress in Patients With Type 2 Diabetes
Study Type
Interventional
2. Study Status
Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
July 2015 (Actual)
Primary Completion Date
January 2016 (Actual)
Study Completion Date
April 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National Nutrition and Food Technology Institute
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non Insulin Dependent Diabetes
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
44 (Actual)
8. Arms, Groups, and Interventions
Arm Title
intervention
Arm Type
Active Comparator
Arm Description
500 mg curcumin capsule
Arm Title
control
Arm Type
Placebo Comparator
Arm Description
placebo
Intervention Type
Dietary Supplement
Intervention Name(s)
Curcumin
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
fasting blood sugar
Time Frame
10 weeks
Title
Insulin
Time Frame
10 week
Title
HbA1c
Time Frame
10 week
Title
Homeostatic Model Assessment of Insulin Resistance
Time Frame
10 week
Title
Change in pancreatic B-cell function
Time Frame
10 week
Secondary Outcome Measure Information:
Title
total capacity antioxidant
Time Frame
10 weeks
Title
Malondialdehyde
Time Frame
10 week
Title
Body mass index
Time Frame
10 week
Title
Waist circumference
Time Frame
10 week
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
NNFTRI clinic
City
Tehran
ZIP/Postal Code
19435
Country
Iran, Islamic Republic of
12. IPD Sharing Statement
Learn more about this trial
Curcumin Supplementation and Patients With Type 2 Diabetes
We'll reach out to this number within 24 hrs