NCT04043702

Brief 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). .

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2019

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 4, 2019

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

July 19, 2019

Completed
1 day until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 20, 2019

Completed
9 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 29, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 2, 2019

Completed
Last Updated

August 2, 2019

Status Verified

August 1, 2019

Enrollment Period

7 months

First QC Date

July 19, 2019

Last Update Submit

August 1, 2019

Conditions

Obesity

Keywords

obesitydrug combinationempagliflozin(jardiance)topiramate(conviban)

Outcome Measures

Primary Outcomes (1)

  • change in weight

    weight measurement

    6 months

Study Arms (4)

on topiramate

"topiramate", "conviban®" group vs no treatment ( control group).

Drug: The intervention being studied

on empagliflozine

"empagliflozine", "jardiance®" vs no treatment ( control group).

Drug: The intervention being studied

on topiramate plus empagliflozine

all patients' vs no treatment ( control group).

Drug: The intervention being studied

no treatment

all patients' vs no treatment ( control group).

Drug: The intervention being studied

Interventions

The intervention being studiedDRUG

Intervention Other Names have not been specified

Also known as: "empagliflozine", "jardiance®"), "topiramate", "conviban®"
no treatmenton empagliflozineon topiramateon topiramate plus empagliflozine

Eligibility Criteria

Age30 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

obese peoples , age from 35 to 55 years

You may qualify if:

  • 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

You may not qualify if:

  • severe anemia
  • hypothyroidism and hyperthyroidism
  • Diabetes mellitus
  • moderate to severe liver or kidney disease
  • body mass index less than 30

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mahmoud Younis

Cairo, 11759, Egypt

Location

MeSH Terms

Conditions

Obesity

Interventions

empagliflozinTopiramate

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

FructoseHexosesMonosaccharidesSugarsCarbohydratesKetoses

Study Officials

  • mahmoud younis, M.S

    egyptian ministry of health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
6 Months
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 19, 2019

First Posted

August 2, 2019

Study Start

January 4, 2019

Primary Completion

July 20, 2019

Study Completion

July 29, 2019

Last Updated

August 2, 2019

Record last verified: 2019-08

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)