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IRCT2017041213678N22 IRCT 2017-06-08 Vice chancellor for research, Urmia University of Medical Sciences The effect of Curcuminoids and Vitamin D3 oral supplementation on the improvement of glycemia and helping the treatment of Diabetic Type 2 patients. 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. 2016-09-28 anticipated 80 Complete https://irct.ir/trial/13467 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Other design features: Table of randomized numbers, has used to randomize subjects into groups. N/A Diabetes Mellitus. Intervention 1: The first group will receive a Vitamin D3 50,000 IU supplement per week for the period of 12 weeks. Intervention 2: 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. Intervention 3: The third group will receive a supplement that contains 500 milligrams of Curcuminoids per day for the period of 12 weeks. Intervention 4: 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.
public Dr Saeed Ghavamzadeh
Nutrition Department, Faculty of Medicine, Urmia University of Medical Science, 11th km of Nazloo Road, Urmia
Urmia Iran (Islamic Republic of) +98 44 3278 0803 Ghavamzadeh_s@yahoo.com; Ghavamzadeh@hotmail.com Urmia University of Medical Sciences scientific Dr Saied Ghavamzadeh
Nutrition Department, Faculty of Medicine, Urmia University of Medical Science, 11th km of Nazloo Road, Urmia
Urmia Iran (Islamic Republic of) +98 44 3278 0803 ghavamzadeh_s@yahoo.com; ghavamzadeh@hotmail.com Urmia University of Medical Sciences Iran (Islamic Republic of) 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. 18 years 75 years Both E11 Non-insulin-dependent diabetes mellitus Treatment - Other Treatment - Other Treatment - Other Placebo The first group will receive a Vitamin D3 50,000 IU supplement per week for the period of 12 weeks. 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. The third group will receive a supplement that contains 500 milligrams of Curcuminoids per day for the period of 12 weeks. 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. Total Cholesterol. Timepoint: Before Intervention and 12 weeks after Intervention. Method of measurement: Enzymatic method, mg/dl. Fasting Blood Sugar. Timepoint: Before Intervention and 12 weeks after Intervention. Method of measurement: Enzymatic method, mg/dl. Triglyceride. Timepoint: Before Intervention and 12 weeks after Intervention. Method of measurement: Enzymatic method, mg/dl. LDL Cholesterol. Timepoint: Before Intervention and 12 weeks after Intervention. Method of measurement: Enzymatic method, mg/dl. HDL Cholesterol. Timepoint: Before Intervention and 12 weeks after Intervention. Method of measurement: Enzymatic method, mg/dl. Hemoglobin A1C. Timepoint: Before Intervention and 12 weeks after Intervention. Method of measurement: HPLC method, Percentage. Insulin Resistance. Timepoint: Before Intervention and 12 weeks after Intervention. Method of measurement: Fasting Blood Sugar (mg/dl) × Serum Insulin (µu/ml) ÷405. Serum Insulin. Timepoint: Before Intervention and 12 weeks after Intervention. Method of measurement: Electro ChemiLuminescence, µU/ml. Fat Mass. Timepoint: Before Intervention and 12 weeks after Intervention. Method of measurement: BIA analyzer, Percentage. Fat Free Mass. Timepoint: Before Intervention and 12 weeks after Intervention. Method of measurement: BIA analyzer, percentage. Body composition. Timepoint: Before intervention and 12 weeks after intervention. Method of measurement: Body composition analyzer (BIA). Body Mass Index. Timepoint: Before Intervention and 12 weeks after Intervention. Method of measurement: BIA, Weight (kg) / [Height (m)]2, kg/m2. Waist to hip circumference. Timepoint: Before Intervention and 12 weeks after Intervention. Method of measurement: BIA analyzer, mm. GLP-1( Glucagon Like Peptide-1). Timepoint: Before Intervention and 12 weeks after Intervention. Method of measurement: Enzyme Linked Immunosorbent Assay, pmol/l. Systolic Blood Pressure. Timepoint: Before Intervention and 12 weeks after Intervention. Method of measurement: Mercury Sphygmomanometer, mmHg. Diastolic Blood Pressure. Timepoint: Before Intervention and 12 weeks after Intervention. Method of measurement: Mercury Sphygmomanometer, mmHg. 25 Hydroxy Vitamin D3. Timepoint: Before Intervention and 12 weeks after Intervention. Method of measurement: Electro ChemiLuminescence, ngr/ml. Student Vice chancellor for research, Urmia University of Medical Sciences Student Approved 2016-09-28 Ethics Committee of Urmia University of Medical Sciences Orjhans Street, Resalat Blvd, Urmia , Iran Urmia Iran (Islamic Republic of)