| Trial ID: | L5620 |
| Source ID: | NCT00456885
|
| Associated Drug: |
Exenatide
|
| Title: |
The Effect of Exenatide on Weight and Hunger in Obese, Healthy Women
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
YES
|
| Results: |
https://ClinicalTrials.gov/show/NCT00456885/results
|
| Conditions: |
Obesity|Impaired Glucose Tolerance
|
| Interventions: |
DRUG: exenatide|DRUG: Placebo
|
| Outcome Measures: |
Primary: Change in Weight, Change in weight at the end of each treatment period., 16 weeks after the beginning of each treatment|Change in Body Mass Index, 16 weeks from the start of each treatment period. | Secondary: Change in Waist Circumference, 16 weeks from the start of each treatment period.|Systolic Blood Pressure, Blood pressure was measured using a Dynamap automated monitoring device. The change is reported as the blood pressure measured at the beginning of the treatment group and after 16 weeks. We are reporting the change in the systolic blood presssure recorded., 16 weeks after the beginning of each treatment|Changes in Body Composition, Per cent body body fat was assessed using bio-electrical impedance with a BIA; RJL System Quantum II Bioelectrical Body Composition Analyzer. The data is reported as per cent body fat., 16 weeks after the beginning of each treatment|Changes in Leptin, 16 weeks from the start of each treatment period.|Diastolic Blood Pressure, 16 weeks after the beginning of each treatment|Adiponectin, 16 weeks after the beginning of each treatment|Change in Insulin, 16 weeks from the start of each treatment period.|Change in Fasting Glucose, 16 weeks from the start of each treatment period.|Change in Two Hour Glucose, 16 weeks from the start of each treatment period.|HOMA Score, 16 weeks from the start of each treatment period.|REE, Resting Energy Expenditure, 16 weeks from the start of each treatment period.
|
| Sponsor/Collaborators: |
Sponsor: Beth Israel Deaconess Medical Center | Collaborators: Amylin Pharmaceuticals, LLC.|Eli Lilly and Company
|
| Gender: |
FEMALE
|
| Age: |
ADULT
|
| Phases: |
PHASE4
|
| Enrollment: |
41
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2007-04
|
| Completion Date: |
2010-09
|
| Results First Posted: |
2017-09-11
|
| Last Update Posted: |
2017-09-11
|
| Locations: |
Beth Israel Deaconess Medical Center, Boston, Massachusetts, 02215, United States
|
| URL: |
https://clinicaltrials.gov/show/NCT00456885
|
