The effect of Curcuminoids and Vitamin D3 oral supplementation on Glucagon-like peptide-1, Serum glycemic and lipid profiles, Blood pressure and Body composition in Diabetic Type 2 patients.
Objective: Evaluating the effects of Curcuminoids and Vitamin D3 oral supplementation on Glucagon Like Peptide- 1 (GLP- 1) and serum glycemic and lipid profiles, blood pressure and body composition in diabetic type 2 patients; double-blind randomized study; 80 patients will be selected with inclusion and exclusion criteria and will randomly be divided into 4 groups for the 12 weeks of intervention. The first group will receive a Vitamin D3 50,000 IU supplement per week, the second group will receive a supplement that contains 500 milligrams of Curcuminoids per day plus one Vitamin D3 50,000 IU supplement per week, the third group will receive one Curcuminoids supplement daily and The control group will receive a placebo capsule that is similar to Curcuminoids supplements but contains Maltodextrin daily and they also will receive a placebo of Vitamin D3 per week. (each supplement of Curcuminoids contains 500 mg of Turmeric extract that consists of 475 mg Curcuminoids and each capsule of placebo contains 500 mg of Maltodextrin) .
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017041213678N22
Registration date:2017-06-08, 1396/03/18
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-06-08, 1396/03/18
Registrant information
Name
Saeed Ghavamzadeh
Name of organization / entity
Urmia University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 44 1278 0803
Email address
ghavamzadeh_s@umsu.ac.ir
Recruitment status
Recruitment complete
Funding source
Investigator and Vice chancellor for research, Urmia University of Medical Sciences
Expected recruitment start date
2016-09-28, 1395/07/07
Expected recruitment end date
2016-12-20, 1395/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Curcuminoids and Vitamin D3 oral supplementation on Glucagon-like peptide-1, Serum glycemic and lipid profiles, Blood pressure and Body composition in Diabetic Type 2 patients.
Public title
The effect of Curcuminoids and Vitamin D3 oral supplementation on the improvement of glycemia and helping the treatment of Diabetic Type 2 patients.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Subjects diagnosed with Type 2 Diabetes (subjects who are positive for any one of these following criteria: FPG level equal or greater than 126 mg/dL, OGTT at 2 h equal or greater than 200 mg/dL and HbA1c equal or greater than 6.5% or in patients with classic hyperlipidemic signs that their random serum glucose level are equal or greater than 200 mg/dL); older than 18 years old; consumption of Glibenclamide, Metformin, Metformin+ Repaglinide drugs or are under treatment regimen. Exclution criteria; Insulin Therapy and consumption of Sitagliptin, Saxagliptin, Byetta and Victosa drugs; changing in the amount of the drugs for the control of pressure or serum lipids in the past 3 months; Use of herbal medicines and anticoagulants (anti- clotting effects are due to curcuminoids); Change the type and dose of medication during intervention; patients on Dialysis or Hemodialysis (they lack the ability to activate vitamin D in the kidneys); pregnant and lactating women (according to the physiological status of the patients and also different needs for vitamin D); The use of alcohol (low and medium risk of type 2 diabetes is associated with lower risk); People with liver disease (liver plays a key role in the activation of vitamin D); Use of calcium supplements and vitamin D in the last 3 months; People with thyroid disease (due to the fact that thyroid hormones in the regulation of lipids, cholesterol and glucose metabolism play an important role, Therefore it is expected that hypothyroidism is involved in the pathogenesis and progression of diabetes); People who have undergone Cholecystectomy surgery and Gall Bladder stone disease (due to stimulation of curcumin on smooth muscle contraction and stimulate the production of bile); People who use Anti epileptic drugs, Thiazide diuretics, Thyroxine, Digoxin, Corticosteroids, Estrogen, Calcitonin (drugs interfering with the homeostasis of vitamin D); acute gastrointestinal problems (decreased absorption); patients with pancreatic cancer and receiving steroids (secondary causes of hyperglycemia); patients with severe heart disease; People with cancer; People with levels higher than allowed 25- (OH) D, 50ng / ml and higher; People with allergies to turmeric; people who did not eat more than 20 percent of the supplements.
Age
From 18 years old to 75 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Table of randomized numbers, has used to randomize subjects into groups.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Urmia University of Medical Sciences
Street address
Orjhans Street, Resalat Blvd, Urmia , Iran
City
Urmia
Postal code
5714783734
Approval date
2016-09-28, 1395/07/07
Ethics committee reference number
IR.UMSU.rec.1395.255
Health conditions studied
1
Description of health condition studied
Diabetes Mellitus
ICD-10 code
E11
ICD-10 code description
Non-insulin-dependent diabetes mellitus
Primary outcomes
1
Description
Total Cholesterol
Timepoint
Before Intervention and 12 weeks after Intervention
Method of measurement
Enzymatic method, mg/dl
2
Description
Fasting Blood Sugar
Timepoint
Before Intervention and 12 weeks after Intervention.
Method of measurement
Enzymatic method, mg/dl
3
Description
Triglyceride
Timepoint
Before Intervention and 12 weeks after Intervention.
Method of measurement
Enzymatic method, mg/dl
4
Description
LDL Cholesterol
Timepoint
Before Intervention and 12 weeks after Intervention.
Method of measurement
Enzymatic method, mg/dl
5
Description
HDL Cholesterol
Timepoint
Before Intervention and 12 weeks after Intervention.
Method of measurement
Enzymatic method, mg/dl
6
Description
Hemoglobin A1C
Timepoint
Before Intervention and 12 weeks after Intervention.
Method of measurement
HPLC method, Percentage
7
Description
Insulin Resistance
Timepoint
Before Intervention and 12 weeks after Intervention.
Before Intervention and 12 weeks after Intervention.
Method of measurement
Electro ChemiLuminescence, µU/ml
9
Description
Fat Mass
Timepoint
Before Intervention and 12 weeks after Intervention.
Method of measurement
BIA analyzer, Percentage
10
Description
Fat Free Mass
Timepoint
Before Intervention and 12 weeks after Intervention.
Method of measurement
BIA analyzer, percentage
11
Description
Body composition
Timepoint
Before intervention and 12 weeks after intervention.
Method of measurement
Body composition analyzer (BIA)
12
Description
Body Mass Index
Timepoint
Before Intervention and 12 weeks after Intervention.
Method of measurement
BIA, Weight (kg) / [Height (m)]2, kg/m2
13
Description
Waist to hip circumference
Timepoint
Before Intervention and 12 weeks after Intervention.
Method of measurement
BIA analyzer, mm
14
Description
GLP-1( Glucagon Like Peptide-1)
Timepoint
Before Intervention and 12 weeks after Intervention
Method of measurement
Enzyme Linked Immunosorbent Assay, pmol/l
Secondary outcomes
1
Description
Systolic Blood Pressure
Timepoint
Before Intervention and 12 weeks after Intervention.
Method of measurement
Mercury Sphygmomanometer, mmHg
2
Description
Diastolic Blood Pressure
Timepoint
Before Intervention and 12 weeks after Intervention.
Method of measurement
Mercury Sphygmomanometer, mmHg
3
Description
25 Hydroxy Vitamin D3
Timepoint
Before Intervention and 12 weeks after Intervention.
Method of measurement
Electro ChemiLuminescence, ngr/ml
Intervention groups
1
Description
The first group will receive a Vitamin D3 50,000 IU supplement per week for the period of 12 weeks.
Category
Treatment - Other
2
Description
The second group will receive a supplement that contains 500 milligrams of Curcuminoids per day plus one Vitamin D3 50,000 IU supplement per week for the period of 12 weeks.
Category
Treatment - Other
3
Description
The third group will receive a supplement that contains 500 milligrams of Curcuminoids per day for the period of 12 weeks.
Category
Treatment - Other
4
Description
The control group will receive a placebo capsules that is similar to Curcuminoids supplements but contains Maltodextrin daily and they also will receive a placebo of Vitamin D3 per week for the period of 12 weeks.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Number 2 clinic of Imam Khomeini Hospital
Full name of responsible person
Shirin Ebrahimkhani
Street address
Number 2 clinic of Imam Khomeini Hospital, Ammar street ,Modarres Blvd ,Urmia
City
Urmia
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Urmia University of Medical Sciences
Full name of responsible person
Dr Iraj Mohebbi
Street address
Urmia University of Medical Sciences staffs department, Orjhans Street, Resalat Blvd, Urmia, Iran
City
Urmia
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Urmia University of Medical Sciences
Proportion provided by this source
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
2
Sponsor
Name of organization / entity
Student
Full name of responsible person
Shirin Ebrahimkhani
Street address
Nutrition Department, Faculty of Medicine, Urmia University of Medical Science, 11th km of Nazloo Road, Urmia
City
Urmia
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Student
Proportion provided by this source
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Urmia University of Medical Sciences
Full name of responsible person
Dr Saeed Ghavamzadeh
Position
PhD in Nutrition Science and Associate Professor
Other areas of specialty/work
Street address
Nutrition Department, Faculty of Medicine, Urmia University of Medical Science, 11th km of Nazloo Road, Urmia
City
Urmia
Postal code
Phone
+98 44 3278 0803
Fax
Email
Ghavamzadeh_s@yahoo.com; Ghavamzadeh@hotmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Urmia University of Medical Sciences
Full name of responsible person
Dr Saied Ghavamzadeh
Position
PhD in Nutrition Science and Associate Professor
Other areas of specialty/work
Street address
Nutrition Department, Faculty of Medicine, Urmia University of Medical Science, 11th km of Nazloo Road, Urmia
City
Urmia
Postal code
Phone
+98 44 3278 0803
Fax
Email
ghavamzadeh_s@yahoo.com; ghavamzadeh@hotmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Urmia University of Medical Sciences
Full name of responsible person
Shirin Ebrahimkhani
Position
Masters student
Other areas of specialty/work
Street address
Nutrition Department, Faculty of Medicine, Urmia University of Medical Science, 11th km of Nazloo Road, Urmia
City
Urmia
Postal code
Phone
Fax
Email
shirin.ebrahimkhani@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)