Healthy
Conditions
Keywords
Exenatide, Byetta, weight loss, energy expenditure, normal volunteers
Brief summary
The purpose of this study is to find out how exenatide causes weight loss. Specifically, the study is assessing how exenatide may change how people take in energy (energy intake), as well as how it may effect how people use energy (energy expenditure).
Detailed description
The bioenergetics study is looking at how and why the diabetes drug exenatide causes people to lose weight.Bioenergetics is the study of how your body burns calories. Adults 18-65 who do not have diabetes and have a body mass index (BMI) between 30 and 40 may be eligible. Women who could get pregnant must be on birth control during the study and women who are pregnant cannot participate in the study. Subjects will take exenatide for 12 weeks. There are 6 study visits in the Univ. Wisconsin Hospital General Clinical Research Center. Visits range from 1 to 6 hours and include blood and urine tests, resting metabolic rate testing over a four hour period, physical exam, ECG, and a be bone mineral density testing at another clinic during 2 clinic visits of the study. All study procedures and testing are free of charge.
Interventions
DRUGExenatide
Exenatide dose was 5 microgram for 2 weeks that was increased to 10 microgram for 10 weeks of treatment.
Sponsors
University of Wisconsin, Madison
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* 18-65 years of age * BMI between 30 and 40 kg/m2 * Women with a negative pregnancy test at baseline, who are sterile, using contraceptives or in a committed relationship with someone who is sterile or using contraception * Absence of weight change greater than 3 kg in the previous 6 months
Exclusion criteria
* Women who are pregnant or lactating * Current or recent (6 months) enrollment in a commercial or self prescribed weight loss or exercise program * Use of weight loss medication * A history of metabolic disease i.e. renal, endocrine, hepatic or gastrointestinal disease that would impact the outcome of the study * Presence of medical conditions that are known to affect energy expenditure (i.e. hyperthyroidism, rheumatoid arthritis, AIDS among others) * History of hypoglycemia * A history of psychiatric or eating disorder * Abnormal EKG * Previous history of pancreatitis * Previous history of gastroparesis or GI motility disorder * Use of medications that can affect GI motility * History of organ transplantation * Other comorbid conditions which may preclude the subject's ability to complete the study * Use of a carbonic anhydrase inhibitor such as acetazolamide
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Energy Intake Measured Before Treatment and at the End of Treatment. | 3 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Weight Loss After Administration of Exenatide. | 3 months | Body weight after overnight fast in light clothing |
Countries
United States
Participant flow
Recruitment details
Recruitment period was ca. 5/1/2008 to 6/30/2010. Subjects were recruited through local advertisements
Pre-assignment details
Subjects were not entered if they failed to meet entry criteria or failed to attend informational appointment
Participants by arm
| Arm | Count |
|---|---|
| Single Arm Study of Exenatide Treatment 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. | 28 |
| Total | 28 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 6 |
| Overall Study | Withdrawal by Subject | 4 |
Baseline characteristics
| Characteristic | Single Arm Study of Exenatide Treatment |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 28 Participants |
| Age, Continuous | 40 years STANDARD_DEVIATION 10 |
| Region of Enrollment United States | 28 participants |
| Sex: Female, Male Female | 18 Participants |
| Sex: Female, Male Male | 10 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 6 / 28 |
| serious Total, serious adverse events | 0 / 28 |
Outcome results
Primary
Change in Energy Intake Measured Before Treatment and at the End of Treatment.
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.
Time frame: 3 months
Population: Those that completed baseline and final measurements.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Exenitide Treatment | Change in Energy Intake Measured Before Treatment and at the End of Treatment. | -167 kcal/d | Standard Deviation 173 |
Comparison: Previously published literature showed an average weight loss of 1.8 kg at 12 weeks of exenatide treatment. This was converted to differ- ence in TEE, estimating an average imbalance of 2 kg × 7800 kcal·kg-1 divided by 84 days or 185 kcal·day-1.We demonstrated an average reproducibility of the DLW method of 6% or 240 kcal·day-1. For a 5% probability of finding this difference with a power of 80%, we determined a need for 14 subjects to complete the study.p-value: 0.001ANOVA
p-value: <0.05t-test, 2 sided
Secondary
Weight Loss After Administration of Exenatide.
Body weight after overnight fast in light clothing
Time frame: 3 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Exenitide Treatment | Weight Loss After Administration of Exenatide. | -2.0 kg | Standard Deviation 2.8 |
Comparison: The null hypothesis was that energy intake was unchanged between the period before treatment and at the end of treatment.p-value: <0.05t-test, 2 sided
p-value: <0.05t-test, 2 sided