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IRCT20170130032293N4 IRCT 2018-03-13 Islamic Azad University Effect of cinnamon on blood glucose and lipid of Type II Diabetes. Study of the effect of cinnamon on blood glucose levels and lipid profiles of Type II Diabetes Patients 2017-12-22 anticipated 60 Complete https://irct.ir/trial/27942 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: First, 120 cards will be prepared in three colors: green, blue, and white (40 for each color). Then, patients who have criteria for entering the study are selected in a Convenience method. To allocate a group, each patient picks up one of the cards in the box and based on the color of the card, in one of the groups of cinnamon 2, cinnamon 4 or control will be placed.The card is returned to the box twice. Cards will be shuffled one more time for every patient. Sampling will be done similarly until the completion of groups, Blinding description: This study is a double-blind study. None of the patients will be informed about which group they are in. People who give medicine to patients, they will not be aware of the type of drug or group of patients. Persons who collect the data, they will also be blind to the groups, but the researcher and final analyst will not be blind. N/A Type 2 diabetes mellitus. The purpose and method of work will be explained for all patients. It is also recommended to patients do not use cinnamon 15 days before and during the study.Written consent will be taken, One intervention group will receive 2 grams and another 4 grams per day of cinnamon powder. The control group receives a placebo. To prepare cinnamon, the cinnamon shell will be turned into powder by an electric mill. Cinnamon powder will be packed in capsules of the same color and shape and size. To the control group, similar capsules containing cellulose will be given. Each participant will receive 4 capsules daily for 8 weeks. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is After the implementation of the research I will decide on its publication.
public parvaneh sarani ali abadi
University Street
zahedan Iran (Islamic Republic of) 9816743545 +98 54 3113 5570 spsarani@yahoo.com Islamic Azad University scientific parvaneh sarani ali abdi
University Street
ZAHEDAN Iran (Islamic Republic of) 9816743545 +98 54 3113 5570 spsarani@yahoo.com Islamic Azad University Iran (Islamic Republic of) The minimum duration of having diabetes mellitus should be five years The range of FBS should be 400-160 mg/dl Glycosylated hemoglobin should be upper 7% The age range should be 40 - 60 years old The patient only uses metformin to control his blood glucose 40 years 60 years Both The patient has insulin therapy. The patient has other anti_glucose drugs or herbal medicines. The patient is pregnant /the patient is lactating mothers. The patient has allergy to cinnamon. The patient has nephropathy, hepatopathy or gastroenrtopathy. The patient has not willing to continue the study E11 Type 2 diabetes mellitus Treatment - Drugs The purpose and method of work will be explained for all patients. It is also recommended to patients do not use cinnamon 15 days before and during the study.Written consent will be taken, One intervention group will receive 2 grams and another 4 grams per day of cinnamon powder. The control group receives a placebo. To prepare cinnamon, the cinnamon shell will be turned into powder by an electric mill. Cinnamon powder will be packed in capsules of the same color and shape and size. To the control group, similar capsules containing cellulose will be given. Each participant will receive 4 capsules daily for 8 weeks Fasting blood sugar levels In milligrams per deciliter, will be measured. Timepoint: Fast Blood Sugar will be measured four times; 1- Before intervention, 2- Four weeks after the intervention, 3- Eight weeks after the intervention; 4- 12 weeks after the intervention. Method of measurement: After about ten hours of fasting, 5 cc venous blood sample from each research unit will be taken.The blood serums is then isolated and glucose level will be measured by glucose oxidase method. The amount of glycosylated hemoglobin, which shows the average amount of blood sugar in the last three months. Timepoint: This variable will be measured four times; 1- Before intervention, 2- Four weeks after the intervention, 3- Eight weeks after the intervention; 4- 12 weeks after the intervention. Method of measurement: After about ten hours of fasting, 5 cc venous blood sample from each research unit will be taken.The blood serums is then isolated and Glycosylated hemoglobin by enzymatic calorimetric method and Using commercial bionic kits, Tehran Pars Azmoon Co. is will be measured. Serum insulin,blood serum insulin levels are measured. Timepoint: This variable will be measured four times; 1- Before intervention, 2- Four weeks after the intervention, 3- Eight weeks after the intervention; 4- 12 weeks after the intervention. Method of measurement: After about ten hours of fasting, 5 cc venous blood sample from each research unit will be taken.The blood serums is then isolated and insulin level will be measured by the chemiluminescence method. Insulin resistance. Timepoint: This variable will be measured four times; 1- Before intervention, 2- Four weeks after the intervention, 3- Eight weeks after the intervention; 4- 12 weeks after the intervention. Method of measurement: After about ten hours of fasting, 5 cc venous blood sample from each research unit will be taken.The blood serums is then isolated and glucose is evaluated by glucose oxidase and insulin by the chemiluminescence method and then Insulin resistance will be measured using the Homeostatic Model Assessment Insulin Resistance(HOMA-IR). Blood lipid levels include Cholesterol, HDL, LDL and Triglyceride. Timepoint: This variables will be measured four times; 1- Before intervention, 2- Four weeks after the intervention, 3- Eight weeks after the intervention; 4- 12 weeks after the intervention. Method of measurement: After ten hours of fasting, 5 cc venous blood sample from each research unit before the intervention, weeks 4, 8 and 12 after the intervention are taken.The blood serums is then isolated and Cholesterol, HDL, LDL, and triglycerides by enzymatic calorimetric method and Using commercial bionic kits, Tehran Pars Azmoon Co. is will be measured. Islamic Azad University Approved 2017-08-29 Ethics Committee of Zahedan Medical University of Sciences Zahedan University Medical Sciences, Hesabi Sq, University Street, Zahedan zahedan Sistan-va-Balouchestan Iran (Islamic Republic of)