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IRCT20230618058524N1 IRCT 2023-07-05 Islamic Azad University Comparison of the effect Of Metformin and Pioglitazone on hypertriglyceridemia(Dyslipidemia) Comparison of the effect Of Metformin and Pioglitazone on hypertriglyceridemia 2023-07-01 anticipated 68 Complete https://irct.ir/trial/70782 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Simple randomization method will be used for randomization. The number of the sample size, that is 68, will be written on special plates from one to sixty eight. The plaques will be poured into a sphere and then will be stirred. A lottery will be drawn for each person and a number will be given to him. Even numbers will be in Metformin group and odd numbers will be in Pioglitazone group. 1 Condition 1: Hypertriglyceridemia. Condition 2: Metabolic syndrom. Intervention 1: Intervention group: The group will be treated with metformin 1000 mg per day and will continue for three months, and at the end of the third month, re-evaluations will be done. Intervention 2: Intervention group: The group will be treated with pioglitazone 15 mg once a day and will continue for three months, and at the end of the third month, re-evaluations will be done. 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 no further information at this time
public Nasrin Razavianzadeh
Khatam al anbia Hospital, Daneshgah Blvd, Shahroud, Semnan province
Shahroud Iran (Islamic Republic of) 3614871151 +98 23 3233 1876 Nasrin_Razavianzadeh50@gmail.com Islamic Azad University scientific Amin Vesali
Khatam Hospital, Daneshgah Blvd, Shahroud, Semnan ptovince
Shahroud Iran (Islamic Republic of) 3614871151 +98 23 3233 1876 amin_vesaly@yahoo.com Islamic Azad University Iran (Islamic Republic of) Age : 25 - 70 ( male, female ) Triglyceride over than 150 mg/dl 25 < BMI < 40 Not using of Metformin, Pioglitazone Not using of Statin drugs 25 years 70 years Both Underlying diseases such as Diabetes, Hypothyroidism, Heart diseases, Kidney failure, Liver failure, Severe infections, Cancer, Inflammatory diseases such as Rheumatoid arthritis and Inflammatory bowel disease. Drug side effects caused by Metformin and Pioglitazone Patients with familial hypertriglyceridemia Patients with Osteoporosis Pregnancy Breastfeeding Having diabetes Alcohol consumption, Addictive drugs BMI > 40 kg/m2 Dissatisfaction with participating or continuing to attend the study Patients with special diets Users of Statins and other Fat-lowering drugs, Corticosteroids E78.1 E88.81 Pure hyperglyceridemia Metabolic syndrome Treatment - Drugs Treatment - Drugs Intervention group: The group will be treated with metformin 1000 mg per day and will continue for three months, and at the end of the third month, re-evaluations will be done. Intervention group: The group will be treated with pioglitazone 15 mg once a day and will continue for three months, and at the end of the third month, re-evaluations will be done. Triglyceride: It is one of the components of the lipid profile, which is one of the main diagnostic components and criteria in metabolic syndrome or insulin resistance syndrome, and has a direct relationship with the individual's insulin resistance conditions. Timepoint: At the beginning of the intervention and then 3 months later. Method of measurement: Laboratory, Hitachi autoanalyzer with mg/dl scale. Cholesterol: including total cholesterol, LDL, HDL, which are other components of the body's lipid profile. It has an active participation in the structure of the body and their quantity and quality is a predictive factor for cardiovascular events. Timepoint: At the beginning of the intervention and then 3 months later. Method of measurement: Laboratory, Hitachi autoanalyzer with mg/dl scale. Weight: Weight change is one of the results of treatment with some drugs. By measuring the weight in the study, results are also obtained regarding the effect of the drugs used on the weight of the patients. Timepoint: At the beginning of the intervention and then 3 months later. Method of measurement: Digital scales in the clinic. Liver function test: Including AST and ALT, which are liver function tests; Any increase in the level of these variables requires liver examination. These enzymes can increase in different cases. They also increase in fatty liver disorder in the field of metabolic syndrome. Their normal level is mostly up to 35. Timepoint: At the beginning of the intervention and then 3 months later. Method of measurement: Laboratory, Hitachi autoanalyzer with U/L scale. Islamic Azad University Approved 2023-04-04 Ethics Committee of Islamic Azad University, Damghan branch Saadi Square, Cheshme Ali Blvd Damghan Semnan Iran (Islamic Republic of)