| Trial ID: | L4125 |
| Source ID: | NCT03968224
|
| Associated Drug: |
Dapagliflozin/Metformin
|
| Title: |
Effectiveness of Dapagliflozin for Weight Loss
|
| Acronym: |
|
| Status: |
UNKNOWN
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
PreDiabetes|Obesity, Morbid|Diabetes Mellitus, Type 2
|
| Interventions: |
DRUG: Dapagliflozin/Metformin|DRUG: Metformin
|
| Outcome Measures: |
Primary: Change in Weight, Change of 10 percent of initial weight, 12 months | Secondary: Change in Blood Pressure, Change of 10 percent of initial blood pressure (systolic and diastolic), 12 months|Change in Waist Circumference, Change of 10 percent of initial waist circumference, 12 months|Change in Triglycerides level, Change of 10 percent of initial triglycerides levels, 12 months | Other: Change in Cytokines Level, Change in interleukin-6, interleukin-10, adiponectin, and resistin, comparing initial versus final levels, 12 months
|
| Sponsor/Collaborators: |
Sponsor: Centro Medico Nacional Siglo XXI IMSS
|
| Gender: |
ALL
|
| Age: |
ADULT
|
| Phases: |
PHASE2|PHASE3
|
| Enrollment: |
90
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: TREATMENT
|
| Start Date: |
2018-07-07
|
| Completion Date: |
2021-07-01
|
| Results First Posted: |
|
| Last Update Posted: |
2020-09-02
|
| Locations: |
Hospital de Especialidades Centro Médico Nacional Siglo XXI, Mexico City, 06720, Mexico
|
| URL: |
https://clinicaltrials.gov/show/NCT03968224
|
