Empagliflozin Addition in Modulating Metabolic Disturbances Associated With Olanzapine in Schizophrenia Patients
- Conditions
- Sodium-glucose Transport Protein Two Inhibitor (SGLT2),Metabolic Deficits Caused by Antipsychotics
- Interventions
- Registration Number
- NCT05669742
- Lead Sponsor
- Tanta University
- Brief Summary
Olanzapine is a thieno-benzodiazepine derivate that is effective managing the symptoms of schizophrenia and reducing the psychopathological symptoms of psychosis. It is also effective in controlling the acute manic episodes associated with bipolar disorder, and have provided some therapeutic advantages over other antipsychotic agents (Citrome et al., 2019).
However, Ola administration has been reported to induce profound BWG accompanied with higher incidence of metabolic deficits, such as hypertension, diabetes and hyperlipidemia, as compared to other antipsychotic agents (Mauri et al., 2014).
Adjunctive treatment with other agents that can minimize or normalize Ola-induced BWG can enhance the safety and tolerability profiles of an effective antipsychotic, thus highlighting the need to develop improved therapies or interventions to minimize these side effects. A meta-analysis of 12 published studies found that antidiabetic drugs such as metformin improved metabolic parameters in patients treated with antipsychotics (de Silva et al., 2016).
These studies encouraged the evaluation of other antidiabetic agents as adjunctive therapies to minimize Ola-induced BWG. Empagliflozin (EMPA)is the third-generation anti-diabetic drug acting as sodium-glucose transport protein two inhibitor (SGLT2), which provides a new mechanism of action to improve glycemic control with modest decreases in systolic blood pressure and body weight (Pradhan et al., 2019). The effects of EMPA on Ola-induced BWG have not been determined and require further investigation.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 40
Schizophrenia Patients treated with Olanzapine with ages ranging from 18 to 60 years.
patients who had any other inflammatory disease (cardiovascular, asthma, bone
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Group 1 as control group olanzapine - Group two as Empagliflozin Empagliflozin -
- Primary Outcome Measures
Name Time Method Change in body weight and body mass index (BMI) up to 12 weeks a person's weight in kilograms (or pounds) divided by the square of height in meters and measure of body fat based on height and weight that applies to adult men and women body mass index = wt (kilogram) divideed by height in meter square
- Secondary Outcome Measures
Name Time Method Adverse events (AE) as measures of safety and tolerability of Empagliflozin up to 12 weeks any side effects of the used intervention