Authors
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[No authors listed]
Category
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Primary study
Registry of Trials»Iranian Registry of Clinical Trials
Year
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2017
INTERVENTION: 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. Placebo 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. 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. Treatment ‐ Other CONDITION: Diabetes Mellitus. ; Non‐insulin‐dependent diabetes mellitus Non‐insulin‐dependent diabetes mellitus PRIMARY OUTCOME: 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. Fasting Blood Sugar. Timepoint: Before Intervention and 12 weeks after Intervention. Method of measurement: Enzymatic method, mg/dl. Fat Free Mass. Timepoint: Before Intervention and 12 weeks after Intervention. Method of measurement: BIA analyzer, percentage. Fat Mass. Timepoint: Before Intervention and 12 weeks after Intervention. Method of measurement: BIA analyzer, Percentage. GLP‐1( Glucagon Like Peptide‐1). Timepoint: Before Intervention and 12 weeks after Intervention. Method of measurement: Enzyme Linked Immunosorbent Assay, pmol/l. 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. LDL Cholesterol. Timepoint: Before Intervention and 12 weeks after Intervention. Method of measurement: Enzymatic method, mg/dl. Serum Insulin. Timepoint: Before Intervention and 12 weeks after Intervention. Method of measurement: Electro ChemiLuminescence, µU/ml. Total Cholesterol. 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. Waist to hip circumference. Timepoint: Before Intervention and 12 weeks after Intervention. Method of measurement: BIA analyzer, mm. SECONDARY OUTCOME: 25 Hydroxy Vitamin D3. Timepoint: Before Intervention and 12 weeks after Intervention. Method of measurement: Electro ChemiLuminescence, ngr/ml. Diastolic Blood Pressure. Timepoint: Before Intervention and 12 weeks after Intervention. Method of measurement: Mercury Sphygmomanometer, mmHg. Systolic Blood Pressure. Timepoint: Before Intervention and 12 weeks after Intervention. Method of measurement: Mercury Sphygmomanometer, mmHg. INCLUSION 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 la
Epistemonikos ID: 94e3e23cf797a45f0c0f36c866d3261f273534d4
First added on: Jul 02, 2024