Investigating biochemical parameters and functional capacity in obese patients with coronary artery occlusive disease trained with a short-term diet

Determining the effect of short-term dietary intervention on biochemical parameters and functional capacity in obese patients with obstructive coronary artery disease.

A clinical trial with a control group, double-blind, simple randomization based on the block method on 100 patients.

All obese patients with coronary artery occlusive disease, who were divided into two control and intervention groups based on simple randomization using the block method, and the patients of each group were invited to the ground floor of Razi Hospital on an empty stomach according to the previous invitation, and the group Intervention After taking the initial tests and performing the functional capacity test (6-minute walk), they are referred to the nutritionist clinic to receive a diet, and the control group is not subjected to any diet.

Eligibility criteria: Coronary patient confirmed to have at least 50% narrowing of the artery; BMI greater than 30; Consent to participate in the study. Exclusion criteria: People with hyperthyroidism; Any type of musculoskeletal disease that prevents patients from walking; Any known cancers in patients; Known 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);

Intervention group: diet recipient Control group: no diet

Distance traveled in the 6 Minutes walking test; Level of fasting blood sugar; Level of lipid profile (LDL, Chol, TG, HDL); SGOT serum level; SGPT serum level; BMI and waist circumference; HbA1C; Systolic and diastolic blood pressure

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.

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.

All data is potentially shareable after de-identifying individuals.

The access period starts 6 months after the results are published.

Researchers working in scientific-university institutions (with reference to the source).

The use of the documentation of the article for other research works is unimpeded by mentioning the source.

Dr. Azadeh Akbari, Cardiac Resident, Birjand University of Medical Sciences, 09154448212

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.

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