| Trial ID: | L3159 |
| Source ID: | NCT02360774
|
| Associated Drug: |
Canagliflozin
|
| Title: |
Mechanisms of Weight Loss With SGLT2 Inhibition
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
YES
|
| Results: |
https://ClinicalTrials.gov/show/NCT02360774/results
|
| Conditions: |
Type 2 Diabetes|Overweight|Obesity
|
| Interventions: |
DRUG: Canagliflozin|DRUG: Placebo
|
| Outcome Measures: |
Primary: Change in Body Weight, Body weight will be measured at each study visit (screening visit, enrollment (study week 0), and at study weeks 2, 4, 8, 12 and 18). Change in body weight will be calculated using ANOVA such that body weight at all time points is included in the data analysis, rather than simply comparing weight at the enrollment visit to weight at the final study visit., 18 weeks (duration of study) | Secondary: Change in Resting Energy Expenditure, Measured Using Indirect Calorimetery, Resting energy expenditure will be measured at each study visit using indirect calorimetery. Data analysis will include change in REE from baseline to study conclusion, as well as change in REE throughout the study., 18 weeks (duration of study)|Change in Body Composition, Measured Using DXA Scanning., Body composition will be measured at baseline and at study completion using DXA scanning., 18 weeks (duration of study)|Change in Glycemic Control, Hemoglobin A1C will be measured at baseline and at study completion., 18 weeks (duration of study)
|
| Sponsor/Collaborators: |
Sponsor: Beth Israel Deaconess Medical Center | Collaborators: Janssen Scientific Affairs, LLC
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE4
|
| Enrollment: |
30
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2015-02
|
| Completion Date: |
2018-08
|
| Results First Posted: |
2018-08-03
|
| Last Update Posted: |
2018-08-03
|
| Locations: |
Beth Israel Deaconess Medical Center, Boston, Massachusetts, 02215, United States
|
| URL: |
https://clinicaltrials.gov/show/NCT02360774
|
