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IRCT20170202032367N11 IRCT 2025-03-16 Tehran University of Medical Sciences The effects of melatonin supplementation on lipid profile, glycemic index, oxidative stress and inflammatory biomarkers in obese patients with type 2 diabetes The effects of melatonin supplementation on lipid profile, glycemic index, oxidative stress and inflammatory biomarkers in obese patients with type 2 diabetes 2024-11-21 anticipated 46 Complete https://irct.ir/trial/80025 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Randomization description: 46 patients are randomly assigned to each group (A/B) using block randomization stratified by age (category 1: under 30/category 2: over 30) and gender (male/female). Random sequences were generated by generating a block random list from www.sealedenvelope.com in 12 blocks of size 4. Treatment allocation of participants, study personnel and outcome wishes were masked and concealed in sealed, opaque numbered envelopes with sequential publication. Patients were randomly divided into two groups in a ratio of 1:1, Blinding description: Due to the fact that the placebo capsule is similar to melatonin in terms of appearance, color, smell, taste, and shape, the people participating in the experiment will not be able to differentiate between the melatonin capsule and the placebo. Blinding of the researcher will be done through the codes included in the packaging of the supplements. 3 Non-insulin-dependent type 2 diabetes. Intervention 1: Intervention group: Intervention group: Before starting the main intervention, all the selected people enter the Run-in period for two weeks, to collect complete information about the patients' food intake. Then, using a general questionnaire, information about age, gender, socio-economic status, education level, history of diseases and hospitalization, surgery and history of taking medicines, supplements and duration of disease will be taken from all people. At the beginning of the study and at the end of the 6th and 12th weeks of the study, in order to investigate the intervening factors of the diet, 24-hour food memory, which includes two non-holiday days and one holiday day, will be taken from the patients through interviews. At the end of the run-in period, people in the intervention group will receive 10 mg melatonin supplement (Karen company) in the form of two 5 mg supplements per day. Intervention 2: Control group: Control group: Before starting the main intervention, all the selected people enter the Run-in period for two weeks, to collect complete information about the patients' food intake. Then, using a general questionnaire, information about age, gender, socio-economic status, education level, history of diseases and hospitalization, surgery and history of taking medicines, supplements and duration of disease will be taken from all people. At the beginning of the study and at the end of the fifth and tenth weeks of the study, in order to investigate the intervening factors of the diet, 24-hour food memory, which includes two non-holiday days and one holiday day, will be taken from the patients through interviews. At the end of the run-in period, people in the control group will receive 2 placebo capsules, which are similar to melatonin in terms of appearance, color, smell, taste and shape, for 10 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 Lack of sufficient information
public Hossein Imani
No. 44, Keshavarz Boulevard, Naderi St., Shahid Hojat Dost Alley
Tehran Iran (Islamic Republic of) 1416643931 +9821889900285 h_imani@sina.tums.ac.ir Tehran University of Medical Sciences scientific Hossein Imani
No. 4, Keshavarz Boulevard, Naderi St., Shahid Hojat Dost Alley
Tehran Iran (Islamic Republic of) 1416643931 0098 21 889900285 h_imani@sina.tums.ac.ir Tehran University of Medical Sciences Iran (Islamic Republic of) At least 6 months and a maximum of 10 years have passed since the diagnosis of the disease by a doctor. Having diabetes diagnosed based on laboratory findings and the opinion of an endocrinologist. Willingness to cooperate in this study Age above 30 and less than 60 years Body mass index above 30 and below 40 kg/m2 Patients who are not candidates for bariatric surgery 30 years 60 years Both At least 6 months and at most 10 years have passed since the diagnosis of the disease by a doctor. Having diabetes diagnosed based on laboratory findings and the opinion of an endocrinologist. Being willing to cooperate in this study Being willing to cooperate in this study Body mass index above 30 and below 40 kg/m2 Patients who are not candidates for bariatric surgery E08 Diabetes mellitus due to underlying condition Rehabilitation Placebo Intervention group: Intervention group: Before starting the main intervention, all the selected people enter the Run-in period for two weeks, to collect complete information about the patients' food intake. Then, using a general questionnaire, information about age, gender, socio-economic status, education level, history of diseases and hospitalization, surgery and history of taking medicines, supplements and duration of disease will be taken from all people. At the beginning of the study and at the end of the 6th and 12th weeks of the study, in order to investigate the intervening factors of the diet, 24-hour food memory, which includes two non-holiday days and one holiday day, will be taken from the patients through interviews. At the end of the run-in period, people in the intervention group will receive 10 mg melatonin supplement (Karen company) in the form of two 5 mg supplements per day. Control group: Control group: Before starting the main intervention, all the selected people enter the Run-in period for two weeks, to collect complete information about the patients' food intake. Then, using a general questionnaire, information about age, gender, socio-economic status, education level, history of diseases and hospitalization, surgery and history of taking medicines, supplements and duration of disease will be taken from all people. At the beginning of the study and at the end of the fifth and tenth weeks of the study, in order to investigate the intervening factors of the diet, 24-hour food memory, which includes two non-holiday days and one holiday day, will be taken from the patients through interviews. At the end of the run-in period, people in the control group will receive 2 placebo capsules, which are similar to melatonin in terms of appearance, color, smell, taste and shape, for 10 weeks. Serum levels of lipid parameters (T.G, T.C, LDL, HDL). Timepoint: Before the intervention and 12 weeks later. Method of measurement: Pars test kit and spectrophotometry method. Serum levels of blood sugar profiles (FBS, HbA1C, HOMA-IR, HOMA-B). Timepoint: Before the intervention and 12 weeks later. Method of measurement: Diagnostic kits. Serum levels of oxidative stress markers (MDA). Timepoint: Before the intervention and 12 weeks later. Method of measurement: Pars test kit and spectrophotometry method. Serum levels of inflammatory markers (hs-CRP, IL-6, TNF-α). Timepoint: Before the intervention and 12 weeks later. Method of measurement: kit Eliza. Systolic and diastolic blood pressure. Timepoint: Before the intervention and 12 weeks later. Method of measurement: Sphygmomanometer and calibrated stethoscope. Sleep quality score. Timepoint: Before the intervention and 12 weeks later. Method of measurement: Sleep quality questionnaire. Carbohydrate, protein, fat and fiber intake. Timepoint: Before the intervention and 12 weeks later. Method of measurement: 24-hour food recall questionnaire. New anthropometric indices (Tyg, WT, VAI, WT). Timepoint: Before the intervention and 12 weeks later. Method of measurement: Calculate. Calculating the risk of chronic diseases using the ASCVD and Framingham criteria. Timepoint: Before the intervention and 12 weeks later. Method of measurement: Calculate. Tehran University of Medical Sciences Approved 2024-09-23 Ethics Committee of Tehran University of Medical Sciences Faculty of Nutrition Sciences and Dietetics, Hojat Dost Alley, Khanaderi, Keshavarz Blvd., Tehran Tehran Tehran Iran (Islamic Republic of)