| Trial ID: | L5851 |
| Source ID: | NCT05136287
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| Associated Drug: |
Glp-1 Receptor Agonist
|
| Title: |
SEMAGLUTIDE VERSUS GLP-1 RECEPTOR AGONISTS. EFFECTIVENESS , SAFETY AND QUALITY OF LIFE IN PATIENTS WITH DIABETES MELLITUS 2. OBSERVATIONAL, PROSPECTIVE AND MULTICENTER STUDY. SEVERAL STUDY.
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| Acronym: |
SEVERAL
|
| Status: |
COMPLETED
|
| Study Results: |
NO
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| Results: |
|
| Conditions: |
Weight Loss|Diabetes Mellitus, Type 2|Quality of Life|Safety Issues
|
| Interventions: |
DRUG: GLP-1 receptor agonist
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| Outcome Measures: |
Primary: Weight loss, The primary outcome will be by assesment of % weight loss, 11 months|Weight loss, Assesment the weiht loss by reduction in Kg, 11 months|Weight loss, Assesment of changes in BMI ( weight (Kg) and height (cm) will be combined to report BMI in kg/m\^2), 11 months | Secondary: HbA1c values, HbA1c changes will be assessed during the study by routine sample tests (%), 11 months|Changes in Quality of life, By using the questionnaire called EuroQol EQ-5D-3L assessment. It has 2 parts, the first one has 5 questions with 3 possible answers (5 dimensions and 3 levels), so each health status has a rate called EVA from 1,0000 (the highest value) to - 0,5095 (the worst health status). The second part is a visual self-assessment between 0 (the worst health status) and 100 (the best health status). https://euroqol.org/, 11 months|Changes in Physical Activity, By using the questionnaire called EuroQol SF-12 assessment.For each of the 8 dimensions, the items are coded, added and transformed on a scale that ranges from 0 (the worst health status for that dimension) to 100 (the best health status)., 11 months|Number of participants experiencing adverse events, Gastrointestinal events; hypoglycemia; pancreatitis; fatigue; ijection reactions; Diabetic retinopathy; cardiac events and other possible events, 11 months
|
| Sponsor/Collaborators: |
Sponsor: Jose Seijas Amigo
|
| Gender: |
ALL
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| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
|
| Enrollment: |
140
|
| Study Type: |
OBSERVATIONAL
|
| Study Designs: |
Observational Model: |Time Perspective: p
|
| Start Date: |
2022-02-01
|
| Completion Date: |
2024-01-01
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| Results First Posted: |
|
| Last Update Posted: |
2024-02-28
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| Locations: |
Centro de Salud de Culleredo, Culleredo, A Coruña, Spain|Centro de Salud de Fene, Fene, A Coruña, Spain|Centro de Salud de Ribeira, Ribeira, A Coruña, Spain|Hospital Clínico Universitario de Santiago de Compostela, Santiago De Compostela, A Coruña, Spain|Centro de Salud de Ribadeo, Ribadeo, Lugo, Spain|Centro de Salud de Vilalba, Vilalba, Lugo, Spain|Centro de Salud de O Carballiño, O Carballiño, Ourense, Spain|Centro de Salud Valmiñor, Nigrán, Pontevedra, Spain|Centro de Salud de O Ventorrillo, A Coruña, Spain|Centro de Salud de San Roque, Lugo, Spain|Centro de Salud Virxe Peregrina, Pontevedra, Spain
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| URL: |
https://clinicaltrials.gov/show/NCT05136287
|
