Combination of Topiramate and Empagliflozin is Considered a Good Option for the Treatment of Obesity

August 1, 2019 updated by: mahmoud younis, Ministry of Health and Population, Egypt

Combination of Topiramate(Conviban) and Empagliflozin(Jardiance) is Considered a Good Option for the Treatment of Obesity

The aim was to show if a combination of topiramate and empagliflozin have the greatest weight decreasing effect in comparison to each drug alone and to group with no treatment( control group).

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Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The aim was to show if a combination of topiramate and empagliflozin have the greatest weight decreasing effect in comparison to each drug alone and to group with no treatment( control group).

Materials and methods 200 obese patients 4 groups. had been monitored in a private clinic, each group 50 patients number, with 35 females and 15 males who were already on treatment.

Study Type

Observational

Enrollment (Actual)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Cairo, Egypt, 11759
        • Mahmoud Younis

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 55 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

obese peoples , age from 35 to 55 years

Description

Inclusion Criteria:

  1. stable weight in the previous 6 months.
  2. a sedentary lifestyle.
  3. no history of diabetes mellitus.
  4. taking medication that affects appetite, or weight within the past 6 months

Exclusion Criteria:

  1. severe anemia
  2. hypothyroidism and hyperthyroidism
  3. Diabetes mellitus
  4. moderate to severe liver or kidney disease
  5. body mass index less than 30

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
on topiramate
"topiramate", "conviban®" group vs no treatment ( control group).
Drug: The intervention being studied
Intervention Other Names have not been specified
Other Names:
  • "empagliflozine", "jardiance®")
  • "topiramate", "conviban®"
on empagliflozine
"empagliflozine", "jardiance®" vs no treatment ( control group).
Drug: The intervention being studied
Intervention Other Names have not been specified
Other Names:
  • "empagliflozine", "jardiance®")
  • "topiramate", "conviban®"
on topiramate plus empagliflozine
all patients' vs no treatment ( control group).
Drug: The intervention being studied
Intervention Other Names have not been specified
Other Names:
  • "empagliflozine", "jardiance®")
  • "topiramate", "conviban®"
no treatment
all patients' vs no treatment ( control group).
Drug: The intervention being studied
Intervention Other Names have not been specified
Other Names:
  • "empagliflozine", "jardiance®")
  • "topiramate", "conviban®"

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
change in weight
Time Frame: 6 months
weight measurement
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ministry of Health and Population, Egypt

Investigators

  • Principal Investigator: mahmoud younis, M.S, Egyptian Ministry of Health

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 4, 2019

Primary Completion (Actual)

July 20, 2019

Study Completion (Actual)

July 29, 2019

Study Registration Dates

First Submitted

July 19, 2019

First Submitted That Met QC Criteria

August 1, 2019

First Posted (Actual)

August 2, 2019

Study Record Updates

Last Update Posted (Actual)

August 2, 2019

Last Update Submitted That Met QC Criteria

August 1, 2019

Last Verified

August 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 12345678

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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