Skip to content

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

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20230114057122N1
Enrollment
44
Registered
2023-02-13
Start date
2022-07-23
Completion date
Unknown
Last updated
2023-03-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity. Overweight and obesity

Interventions

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

Sponsors

Shahid Beheshti University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 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.

Exclusion criteria

Exclusion criteria: Exclusion criteria: Any type of acute illness during the study; not comply with intervention or diet (less than 80% compliance)

Design outcomes

Primary

MeasureTime frame
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).

Secondary

MeasureTime frame
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.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactMajid Valizadeh

Shahid Beheshti University of Medical Sciences

valizadeh@endocrine.ac.ir+98 21 2243 2500

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026