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IRCT20230731058983N1 IRCT 2023-11-14 Birjand University of Medical Sciences Investigating biochemical parameters and functional capacity in obese patients with coronary artery occlusive disease trained with a short-term diet Investigating biochemical parameters and functional capacity in obese patients with coronary artery occlusive disease trained with a short-term diet 2023-11-17 anticipated 100 Complete https://irct.ir/trial/71683 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: The method of randomization of patients in this study will be block randomization and the blocks will be considered quadruple in this study. The tool for randomization and creating a random sequence will be Excel software. The random between function will be used to create a random sequence. Random blocks will be placed in numbered sealed envelopes. After randomly selecting each envelope, the desired block will be removed from the statistical sample and the sampling will continue until the work is completed, Blinding description: The blinding used in this study will be double-blind. In other words, in this study, the patients and the person evaluating the study will not know the assignment of the group to the studied arms, and it will be specified as A and B in the data collection form. In this study, we do not have a placebo, but the studied groups are not related to each other, because in the call, conditions are provided in such a way that it is not possible for people to meet each other. In terms of physical activity, the two groups will have routine conditions so that it is possible to examine the effect of diet closer to reality. In this study, the outcomes studied will include biochemical factors and the 6-minute walk test, which is observed by a third person (a person who not the principal investigator of the study) will be done to avoid detection bias. N/A Condition 1: coronary artery disease. Condition 2: obesity. Condition 3: blood pressure. Condition 4: diabet. Intervention 1: Intervention group: All patients in the intervention group are provided with a three-month short-term balanced diet by a nutritionist. This visit will last for at least half an hour and a short-term diet will be provided to each patient based on a balanced diet, and the necessity of following the diet and the importance of weight loss will be explained to the patient, and it will be emphasized to them that During this period, do not make any other changes in your lifestyle, such as starting a club sports program. Patients are followed up monthly to ensure compliance with the diet. Intervention 2: Control group: all patients of the control group refer to the study site according to the previous call and the aforementioned tests and the 6-minute walk test are taken from them and without receiving a special diet and advice not to change their daily diet, again after three months. They will be called and the mentioned tests and the 6-minute walk test will be taken from them again. Yes - There is a plan to make this available What will be shared: All data is potentially shareable after de-identifying individuals. When: The access period starts 6 months after the results are published. To whom: Researchers working in scientific-university institutions (with reference to the source). Conditions: The use of the documentation of the article for other research works is unimpeded by mentioning the source. Where to obtain: Dr. Azadeh Akbari, Cardiac Resident, Birjand University of Medical Sciences, 09154448212 How to obtain: Non-identifiable data of individuals as well as the study protocol will be available to other researchers (with reference to the source) 6 months after the publication of the article. Comments: .
public Azadeh Akbari
Razi Hospital, Ghaffari Blvd
Birjand Iran (Islamic Republic of) 9717844471 +98 56 3162 6000 Akbari.Azad@gmail.com Birjand University of Medical Sciences scientific Azadeh Akbari
Razi Hospital, Ghaffari Blvd
Birjand Iran (Islamic Republic of) 9717844471 +98 56 3162 6000 Akbari.Azad@gmail.com Birjand University of Medical Sciences Iran (Islamic Republic of) coronary artery disease with at least 50% stenosis BMI more than 30 patient satisfaction Age above 18 years 18 years no limit Both coronary artery disease with less than 50% stenosis BMI less than 30 patients with hyperthyroidism Any type of musculoskeletal and rheumatologic disease that prevents patients from walking Age under 18 years Any known cancers in patients Known chronic kidney disease in patients (such as types of glomerulonephritis or patients undergoing routine dialysis) Known liver disease in patients (such as types of viral hepatitis and autoimmune hepatitis) Immunocompromised patients People with disabilities Bedridden people I25.1 E66.0 Z01.3 E11 Atherosclerotic heart disease of native coronary artery Obesity due to excess calories Examination of blood pressure Type 2 diabetes mellitus Lifestyle N/A Intervention group: All patients in the intervention group are provided with a three-month short-term balanced diet by a nutritionist. This visit will last for at least half an hour and a short-term diet will be provided to each patient based on a balanced diet, and the necessity of following the diet and the importance of weight loss will be explained to the patient, and it will be emphasized to them that During this period, do not make any other changes in your lifestyle, such as starting a club sports program. Patients are followed up monthly to ensure compliance with the diet. Control group: all patients of the control group refer to the study site according to the previous call and the aforementioned tests and the 6-minute walk test are taken from them and without receiving a special diet and advice not to change their daily diet, again after three months. They will be called and the mentioned tests and the 6-minute walk test will be taken from them again. Distance covered in the 6 Minutes Walking test. Timepoint: at 0 and 3 months after the intervention in the two investigated groups. Method of measurement: Checking the distance traveled during 6 minutes. Level of fasting blood sugar. Timepoint: Time zero and 3 months after the intervention in the two studied groups. Method of measurement: Hospital laboratory kit. Serum level of lipid profile (LDL, Chol, TG, HDL). Timepoint: Time zero and 3 months after the intervention in the two studied groups. Method of measurement: Hospital laboratory kit. Serum levels of SGOT and SGPT. Timepoint: Time zero and3 months after the intervention in the two studied groups. Method of measurement: Hospital laboratory kit. BMI and waist circumference. Timepoint: Time zero and 3 months after the intervention in the two studied groups. Method of measurement: scale and meter. HbA1C. Timepoint: Time zero and 3 months after the intervention in the two studied groups. Method of measurement: Hospital laboratory kit. Average systolic and diastolic blood pressure. Timepoint: Time zero and 3 months after the intervention in the two studied groups. Method of measurement: blood pressure device. Birjand University of Medical Sciences Approved 2023-07-24 Ethics committee of Birjand University of Medical Science Faculty of medicine,University of Medical Science, Ghaffari Blvd Birjand South Khorasan Iran (Islamic Republic of)