Effect of Empagliflozin and Topiramate co-administration on anthropometric indices and metabolic markers in individuals with excess weight on a calorie restricted diet

Determining the effect of Empagliflozin and Topiramate co-administration on anthropometric indices and metabolic markers in individuals with excess weight on a calorie restricted diet

Clinical trial with control group, with parallel groups, double-blind, randomized, phase 3 on 44 patients

In this study, individuals with excess wight referring to the obesity clinic, Tehran are asked to complete a written informed consent form. Individuals will be randomly assigned to one of the intervention or placebo groups. At baseline and end of the study, anthropometric indices will be measured. Also, 10 cc of blood will be taken from participants and glucose and lipid profiles as well as inflammatory factors will be determined. Empagliflozin and topiramate tablets and their placeboes will be placed into identical containers.

Inclusion criteria: Men and women >18 years; with body mass index 30-40 kg/m2 with or without hypertension and/or dyslipidemia, or body mass index 27-30 kg/m2 with hypertension and/or dyslipidemia; without diabetes. Exclusion criteria: Not comply with intervention or diet

Intervention group: 22 Individuals with excess weight and without diabetes receive 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, for 12 weeks. Placebo group: 22 individuals with excess weight and without diabetes receive calorie restricted diet (with 500 kcal less than energy required) with a placebo of empagliflozin and topiramate, daily.

The primary outcomes in this study are changes in weight and percentage of fat mass.

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.

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.

A part of the data will be shared, such as primary outcomes

Six months after the publication of the results

Researchers and students of university

Six months after the publication of this study papers, the obtained data will be available to the applicant researchers and students for further analysis.

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

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