Trial Outcomes & Findings for Bioenergetic Alterations After Exenatide Administration (NCT NCT00623545)
NCT ID: NCT00623545
Last Updated: 2015-01-09
Results Overview
Energy intake is as calculated from energy expenditure as measured by doubly labeled water and change in body energy stores before and at the end of treatment. Units are kcal/d.
COMPLETED
PHASE4
28 participants
3 months
2015-01-09
Participant Flow
Recruitment period was ca. 5/1/2008 to 6/30/2010. Subjects were recruited through local advertisements
Subjects were not entered if they failed to meet entry criteria or failed to attend informational appointment
Participant milestones
| Measure |
Single Arm Study of Exenatide Treatment
Subjects serve as their own controls. Measures of outcome variables are made before treatment and again at the end of the1 treatment period made. Outcomes are based on the change in these variables.
|
|---|---|
|
Overall Study
STARTED
|
28
|
|
Overall Study
COMPLETED
|
18
|
|
Overall Study
NOT COMPLETED
|
10
|
Reasons for withdrawal
| Measure |
Single Arm Study of Exenatide Treatment
Subjects serve as their own controls. Measures of outcome variables are made before treatment and again at the end of the1 treatment period made. Outcomes are based on the change in these variables.
|
|---|---|
|
Overall Study
Adverse Event
|
6
|
|
Overall Study
Withdrawal by Subject
|
4
|
Baseline Characteristics
Bioenergetic Alterations After Exenatide Administration
Baseline characteristics by cohort
| Measure |
Single Arm Study of Exenatide Treatment
n=28 Participants
Subjects serve as their own controls. Measures of outcomes are performed before and at the end of treatment. Outcomes are based on the change in the variables.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
28 Participants
n=99 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
|
Age, Continuous
|
40 years
STANDARD_DEVIATION 10 • n=99 Participants
|
|
Sex: Female, Male
Female
|
18 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
28 participants
n=99 Participants
|
PRIMARY outcome
Timeframe: 3 monthsPopulation: Those that completed baseline and final measurements.
Energy intake is as calculated from energy expenditure as measured by doubly labeled water and change in body energy stores before and at the end of treatment. Units are kcal/d.
Outcome measures
| Measure |
Exenitide Treatment
n=18 Participants
There is one treatment arm. Subjects serve as their own controls for the outcome measure. The measures are made before the treatment is started at during the end of the treatment.
|
|---|---|
|
Change in Energy Intake Measured Before Treatment and at the End of Treatment.
|
-167 kcal/d
Standard Deviation 173
|
SECONDARY outcome
Timeframe: 3 monthsBody weight after overnight fast in light clothing
Outcome measures
| Measure |
Exenitide Treatment
n=18 Participants
There is one treatment arm. Subjects serve as their own controls for the outcome measure. The measures are made before the treatment is started at during the end of the treatment.
|
|---|---|
|
Weight Loss After Administration of Exenatide.
|
-2.0 kg
Standard Deviation 2.8
|
Adverse Events
Single Arm Study of Exenatide Treatment
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Single Arm Study of Exenatide Treatment
n=28 participants at risk
|
|---|---|
|
Gastrointestinal disorders
nausea
|
17.9%
5/28 • Number of events 5 • 3 months
periodic self-report
|
|
Psychiatric disorders
claustrophobia
|
3.6%
1/28 • Number of events 1 • 3 months
periodic self-report
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place