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IRCT20160913029802N3 IRCT 2021-12-07 Mazandaran University of Medical Sciences Evaluation of the effect of medlar fruit molasses on blood glucose control in children and adolescents with type 1 diabetes Evaluation of the effect of medlar fruit molasses (Mespilus germanica L.) on blood glucose control in children and adolescents with type 1 diabetes - A randomized clinical trial 2021-11-11 anticipated 30 Complete https://irct.ir/trial/56475 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Crossover, Purpose: Treatment, Randomization description: In this study, we will use the restricted randomization method (the blocked randomization) using Random Allocation Software. The size of all blocks is equal and in this trial, we will have five blocks of 6 (including 3 participants in group A and 3 participants in group B). Each patient will receive a unique code and the software will randomly place the patients in groups A or B, depending on the sample size in each block. N/A Type 1 diabetes. Intervention 1: Intervention group A: After randomization allocation, in the first 45 days, group A receives a certain amount of medlar fruit molasses (the dose is determined based on the total phenol content of the product) along with the required dose of insulin. The wash out period is two weeks, during which patients do not receive any intervention other than insulin injection.During the second 45-day period, this group will receive only the insulin they need.Patient demographic information including age, sex, height and weight as well as HbA1c levels are measured at the beginning of the study, day 45 (time of group switching) and the end of the study. Intervention 2: Intervention group B: After randomization allocation, in the first 45 days, this group will receive only the insulin they need. Then the wash out period is two weeks and during this period patients do not receive any intervention except insulin injection. In the second 45-day period, group B receives a certain amount of medlar fruit molasses(the dose is determined based on the total phenol content of the product) along with the required dose of insulin. Patient demographic information including age, sex, height and weight as well as HbA1c levels are measured at the beginning of the study, day 45 (time of group switching) and the end of the study. 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 There is not any more information
public Somayeh Shahani
Faculty of Pharmacy, Mazandaran University of Medical Sciences, Km 18 of Khazarabad Road
Sari Iran (Islamic Republic of) 48471-93698 +98 11 3354 3761 so.shahani@yahoo.com Mazandaran University of Medical Sciences scientific Somayeh Shahani
Faculty of Pharmacy, Mazandaran University of Medical Sciences, Km 18 of Khazarabad Road
Sari Iran (Islamic Republic of) 48471-93698 +98 11 3354 3761 so.shahani@yahoo.com Mazandaran University of Medical Sciences Iran (Islamic Republic of) The age group of patients is between 5-18 years. Children and adolescents with poorly controlled type 1 diabetes (HbA1c≥8). The consent of the patient and parents to participate in the study has been obtained. 5 years 18 years Both Patients with syndromic disorders (such as Down syndrome, etc.) Presence of renal failure in the patient (GFR <30) Taking drugs that affect blood sugar levels (lowering blood sugar such as metformin and raising blood sugar such as corticosteroids) E10 Type 1 diabetes mellitus Treatment - Drugs Treatment - Drugs Intervention group A: After randomization allocation, in the first 45 days, group A receives a certain amount of medlar fruit molasses (the dose is determined based on the total phenol content of the product) along with the required dose of insulin. The wash out period is two weeks, during which patients do not receive any intervention other than insulin injection.During the second 45-day period, this group will receive only the insulin they need.Patient demographic information including age, sex, height and weight as well as HbA1c levels are measured at the beginning of the study, day 45 (time of group switching) and the end of the study. Intervention group B: After randomization allocation, in the first 45 days, this group will receive only the insulin they need. Then the wash out period is two weeks and during this period patients do not receive any intervention except insulin injection. In the second 45-day period, group B receives a certain amount of medlar fruit molasses(the dose is determined based on the total phenol content of the product) along with the required dose of insulin. Patient demographic information including age, sex, height and weight as well as HbA1c levels are measured at the beginning of the study, day 45 (time of group switching) and the end of the study. C-Peptide. Timepoint: To determine the level of C-Peptide in patients, a blood sample is taken from the patient on an empty stomach and at intervals of 30, 60, 90 and 120 minutes after consuming a mixture of liquid (containing 50% carbohydrates, 30% fat and 20% protein with a standard concentration of 6 ml per kg, up to 360 ml). Method of measurement: ELIZA Reader. HbA1c. Timepoint: HbA1c (using Biroex kit) is measured at the beginning of the study, day 45 (group switching time) and the end of the study, in the laboratory of Bu-Ali Sina Hospital in Sari. Method of measurement: Hemoglobin A1c analyzer. Vice chancellor for research and technology, Mazandaran University of Medical Sciences Approved 2021-09-29 Ethics committee of Mazandaran University of Medical Sciences Vice Chancellor for Research and Technology, Moallem Square Sari Mazandaran Iran (Islamic Republic of)