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IRCT20230114057122N1 IRCT 2023-02-13 Shahid Beheshti University of Medical Sciences Effect of Empagliflozin and Topiramate co-administration in individuals with excess weight on a calorie restricted diet Effect of Empagliflozin and Topiramate co-administration on anthropometric indices and metabolic markers in individuals with excess weight on a calorie restricted diet 2022-07-23 anticipated 44 Complete https://irct.ir/trial/68026 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: For randomized allocation performing, permuted block randomization will be used by blocks with size of 4. According to the sample size of 44 subjects, 11 blocks will be generated using the online site (www.sealedenvelope.com). In order to allocation concealment in the randomized process, unique codes will be used on the drug boxes that is generated by the software. Participants will be entered into the study based on the produced sequence. The drug packets will be allocated to the individual with code on them. Therefore, participants will be unaware of the type of intervention that will receive, as well as the random sequence which will be hidden and unpredictable, Blinding description: In order to performing the double-blinded of the study, before the study beginning, the containers containing tablets will be provided by someone other than the researchers, and the placebo tablets in appearance are similar to the tables and the researchers are not aware about the allocation of studied subjects in each group during the evaluation of the outcomes until the end of the intervention period. 3 Obesity. Intervention 1: Intervention group: A calorie restricted diet (with 500 kcal less than energy required) with an empagliflozin (10 mg) and topiramate (25 mg/day in the first week of intervention and if tolerated by the participants, the dose will increase to 50 mg/day (BD) from the second week till end of the intervention), daily. Intervention 2: Control group: A calorie restricted diet (with 500 kcal less than energy required) with a placebo of empagliflozin and topiramate, which are similar in appearance to empagliflozin and topiramate, daily. Yes - There is a plan to make this available What will be shared: A part of the data will be shared, such as primary outcomes When: Six months after the publication of the results To whom: Researchers and students of university Conditions: Six months after the publication of this study papers, the obtained data will be available to the applicant researchers and students for further analysis. Where to obtain: Applicants can be contacted with corresponding author by e-mail or postal address to receive the requested data. Postal address: Obesity Research Center, Research Institute for Endocrine Sciences, Shahid Beheshti University of Medical Sciences, Tehran. Phone number: 0098 21 22432500. E-mail: valizadeh@endocrine.ac.ir How to obtain: Applicants can be contacted with corresponding author by e-mail or postal address to receive the requested data. Postal address: Obesity Research Center, Research Institute for Endocrine Sciences, Shahid Beheshti University of Medical Sciences, Tehran. Phone number: 0098 21 22432500. E-mail: valizadeh@endocrine.ac.ir Comments:
public Majid Valizadeh
Arabi Street, Velenjak
Tehran Iran (Islamic Republic of) 1985717413 +98 21 2243 2500 valizadeh@endocrine.ac.ir Shahid Beheshti University of Medical Sciences scientific Majid Valizadeh
Arabi Street, Velenjak
Tehran Iran (Islamic Republic of) 1985717413 +98 21 2243 2500 valizadeh@endocrine.ac.ir Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Inclusion criteria: Men and women over 18 years of age; with body mass index 30-40 kg/m2 with or without hypertension and/or dislipidemia, or body mass index 27-30 kg/m2 with hypertension and/or dislipidemia; without diabetes or eating disorders; not taking vitamin and mineral supplements; not being pregnant or breastfeeding. 18 years no limit Both Exclusion criteria: Any type of acute illness during the study; not comply with intervention or diet (less than 80% compliance) E66 Overweight and obesity Treatment - Drugs Placebo Intervention group: A calorie restricted diet (with 500 kcal less than energy required) with an empagliflozin (10 mg) and topiramate (25 mg/day in the first week of intervention and if tolerated by the participants, the dose will increase to 50 mg/day (BD) from the second week till end of the intervention), daily. Control group: A calorie restricted diet (with 500 kcal less than energy required) with a placebo of empagliflozin and topiramate, which are similar in appearance to empagliflozin and topiramate, daily. Anthropometric indices. Timepoint: Before the intervention and 12 weeks after intervention. Method of measurement: The height will be measured with a stadiometer at a standing position, body weight will be measured using a Beurer scale (Beurer, Germany), The waist circumference is measured with inflexible tape measure. The percentage of body fat mass will be determined by bioelectrical impedance analysis (Quad scan 4000; Bodystat). Fasting blood glucose. Timepoint: Before the intervention and 12 weeks after intervention. Method of measurement: Fasting blood glucose levels will be measured using ELISA method. Shahid Beheshti University of Medical Sciences Approved 2022-06-26 Ethics Committee of Shahid Beheshti University of Medical Sciences Arabi Street, Velenjak Tehran Tehran Iran (Islamic Republic of)