ObesityNCT04043702
Combination of Topiramate and Empagliflozin is Considered a Good Option for the Treatment of Obesity
An observational study of Obesity, run by Ministry of Health and Population, Egypt at 1 site in Egypt.
Trial summary
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). . Read more about this study
- Who is it for?
- Ages 30 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- The intervention being studied
- How many people
- 200 participants
- Where
- 1 siteEgypt
- Study dates
- 4 Jan 2019to 29 Jul 2019
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: obese peoples , age from 35 to 55 years
Who may be able to join
- stable weight in the previous 6 months.
- a sedentary lifestyle.
- no history of diabetes mellitus.
- taking medication that affects appetite, or weight within the past 6 months
Who cannot join
- severe anemia
- hypothyroidism and hyperthyroidism
- Diabetes mellitus
- moderate to severe liver or kidney disease
- body mass index less than 30
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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).
.
Read the 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.
- Conditions
- Obesity
- Being tested
- The intervention being studied
- Keywords
- obesity, drug combination, empagliflozin(jardiance), topiramate(conviban)
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The intervention being studiedDrug
Also called "empagliflozine", "jardiance®"), "topiramate", "conviban®"
Intervention Other Names have not been specified
| Study group | Role | What they receive |
|---|---|---|
| on topiramate | "topiramate", "conviban®" group vs no treatment ( control group). Receives: Drug: The intervention being studied | |
| on empagliflozine | "empagliflozine", "jardiance®" vs no treatment ( control group). Receives: Drug: The intervention being studied | |
| on topiramate plus empagliflozine | all patients' vs no treatment ( control group). Receives: Drug: The intervention being studied | |
| no treatment | all patients' vs no treatment ( control group). Receives: Drug: The intervention being studied |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in weight
weight measurement
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2019
- Study start4 Jan 2019
- Primary completion20 Jul 2019
- Study completion29 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (actual)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Ministry of Health and Population, Egypt
- Sponsor type
- Other government
- Responsible party
- Principal investigator, mahmoud younis, Cairo University
- Investigators
- mahmoud younis, M.S, Principal investigator, egyptian ministry of health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04043702
- Sponsor's protocol ID
- 12345678
- Status last verified
- Aug 2019
- First submitted
- 19 Jul 2019
- Last updated
- 2 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combination of Topiramate(Conviban) and Empagliflozin(Jardiance) is Considered a Good Option for the Treatment of Obesity
- ClinicalTrials.gov ID
- NCT04043702
- Acronym / sponsor ID
- 12345678
- Conditions
- Obesity
- Keywords
- obesity, drug combination, empagliflozin(jardiance), topiramate(conviban)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Ministry of Health and Population, EgyptOther government
- Study start
- 4 Jan 2019 (actual)
- Primary completion
- 20 Jul 2019 (actual)
- Study completion
- 29 Jul 2019 (actual)
- First posted
- 2 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| on topiramate | – | Drug: The intervention being studied"topiramate", "conviban®" group vs no treatment ( control group). |
| on empagliflozine | – | Drug: The intervention being studied"empagliflozine", "jardiance®" vs no treatment ( control group). |
| on topiramate plus empagliflozine | – | Drug: The intervention being studiedall patients' vs no treatment ( control group). |
| no treatment | – | Drug: The intervention being studiedall patients' vs no treatment ( control group). |
Who may qualify
- Ages
- 30 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- obese peoples , age from 35 to 55 years
Key inclusion criteria (4 listed)
- stable weight in the previous 6 months.
- a sedentary lifestyle.
- no history of diabetes mellitus.
- taking medication that affects appetite, or weight within the past 6 months
Key exclusion criteria (5 listed)
- severe anemia
- hypothyroidism and hyperthyroidism
- Diabetes mellitus
- moderate to severe liver or kidney disease
- body mass index less than 30
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| The intervention being studiedAlso: "empagliflozine", "jardiance®"), "topiramate", "conviban®"Intervention Other Names have not been specified | Drug | no treatment, on empagliflozine, on topiramate, on topiramate plus empagliflozine |
Primary outcome
change in weight
Time frame: 6 months
weight measurement
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
mahmoud younis, M.S principal investigator
egyptian ministry of health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity, run by Ministry of Health and Population, Egypt at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change in weight (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Aug 2019.