A Phase 4 interventional study of exenatide and Placebo in Obesity and Impaired Glucose Tolerance, sponsored by Beth Israel Deaconess Medical Center. Completed at 1 site in United States. Open to female participants aged 25 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-09-11.
Sponsored by Beth Israel Deaconess Medical Center · Phase 4, Interventional, and Treatment
This study will look at the effect of exenatide, a drug which has been approved for the treatment of type 2 diabetes, on body weight, appetite and energy expenditure among moderately obese women without diabetes.
The study is 35 weeks long and includes 19 outpatient visits. Participants will receive exenatide for 16 weeks and placebo for 16 weeks with a 3 week rest period in between. Neither participants nor investigators will know whether exenatide or placebo is being administered. Participants will be started randomly on either exenatide or placebo.
Our hypothesis is that treatment with exenatide will curb appetite and lead to weight loss and may lead to changes in energy expenditure.
This study will examine the effect of exenatide on body weight, energy expenditure, satiety, sleep, and metabolic parameters in healthy, moderately obese women (BMI 28-35 kg/m2). We will look at 2 populations of women, one with normal glucose metabolism and one with impaired glucose homeostasis (IGH)--either impaired fasting glucose (IFG, fasting glucose 101-125 mg/dL) or impaired glucose tolerance (IGT, glucose 140-199 mg/dL 2h after a 75g oral glucose load). This is a randomized, double blind, crossover study with two 16-week treatment periods separated by a 3-week washout period. There are 19 study visits over 35 weeks.
The goals of this study are 1) to examine the effect of exenatide on body weight and dysglycemia in populations in which this medication has not been studied, namely obese women with and without IGH and 2) to investigate possible mechanisms of weight loss through measurements of energy expenditure, hunger, satiety, nausea, and sleep.
The primary outcome of this study is weight loss. We will calculate absolute and relative change in body weight from baseline to week 16 (the first treatment period) and from week 19 to week 35 (the second treatment period). Body weight will be measured at every study visit which will also allow us to assess the absolute and relative change from baseline throughout the entire study.
778 studies on the registry are indexed under Glucose Intolerance; 129 are open to participants now.
This study's enrollment of 41 is below the median of 60 across 645 interventional studies indexed under Glucose Intolerance.
Browse Glucose Intolerance studies →Beth Israel Deaconess Medical Center is the lead sponsor of 560 studies on the registry; 80 are open to participants now.
Of its 75 completed or terminated interventional studies of FDA-regulated products, 61 (81%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Started on Exenatide, 3 week washout, start placebo
Drug: exenatide · Drug: Placebo
Started on placebo, 3 week washout, start exenatide
Drug: exenatide · Drug: Placebo
5 microgram twice a day for two week and then 10 mcg for remaining 15 weeks
Also known as: Byetta
Twice daily injection of placebo
Change in Weight
Change in weight at the end of each treatment period.
Time frame: 16 weeks after the beginning of each treatment
Change in Body Mass Index
Time frame: 16 weeks from the start of each treatment period.
Change in Waist Circumference
Time frame: 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.
Time frame: 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.
Time frame: 16 weeks after the beginning of each treatment
Changes in Leptin
Time frame: 16 weeks from the start of each treatment period.
Diastolic Blood Pressure
Time frame: 16 weeks after the beginning of each treatment
Adiponectin
Time frame: 16 weeks after the beginning of each treatment
Change in Insulin
Time frame: 16 weeks from the start of each treatment period.
Change in Fasting Glucose
Time frame: 16 weeks from the start of each treatment period.
Change in Two Hour Glucose
Time frame: 16 weeks from the start of each treatment period.
HOMA Score
Time frame: 16 weeks from the start of each treatment period.
REE
Resting Energy Expenditure
Time frame: 16 weeks from the start of each treatment period.
Flyers, Craig's list, posters used for recruitment.Recruitment occurred between 2007 and 2010. After telephone screen subjects were evaluated at the BIDMC clinical research center.
| Milestone | Exenatide First, Then Placebo | Placebo First, Then Exenatide |
|---|---|---|
| Started | 24 | 17 |
| Completed | 24 | 17 |
| Not completed | 0 | 0 |
| Milestone | Exenatide First, Then Placebo | Placebo First, Then Exenatide |
|---|---|---|
| Started | 24 | 17 |
| Completed | 24 | 17 |
| Not completed | 0 | 0 |
| Milestone | Exenatide First, Then Placebo | Placebo First, Then Exenatide |
|---|---|---|
| Started | 24 | 17 |
| Completed | 23 | 17 |
| Not completed | 1 | 0 |
Change in weight at the end of each treatment period.
| kilograms | Exenatide | Placebo |
|---|---|---|
| Change in Weight | -2.49 ± 0.66 | 0.43 ± 0.63 |
| Kg/m^2 | Exenatide | Placebo |
|---|---|---|
| Change in Body Mass Index | -0.93 (-1.44 to -0.41) | 0.18 (-0.31 to 0.68) |
| centimeters | Exenatide | Placebo |
|---|---|---|
| Change in Waist Circumference | -1.68 (-3.3 to -0.07) | 0.94 (-0.59 to 2.47) |
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.
| mm of mercury | Exenatide | Placebo |
|---|---|---|
| Systolic Blood Pressure | -2.5 (-6.6 to 1.6) | -1.3 (-5.2 to 2.6) |
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.
| per cent | Exenatide | Placebo |
|---|---|---|
| Changes in Body Composition | -0.4 (-1.5 to 0.7) | -0.7 (-1.8 to 0.3) |
| ng/ml | Exenatide | Placebo |
|---|---|---|
| Changes in Leptin | -3.7 (-7.4 to 0.05) | -0.2 (-3.8 to 3.3) |
| mm of mercury | Exenatide | Placebo |
|---|---|---|
| Diastolic Blood Pressure | -1.2 (-3.6 to 1.1) | -0.4 (-2.6 to 1.9) |
| microgram per ml | Exenatide | Placebo |
|---|---|---|
| Adiponectin | 0.4 (-0.3 to 1.0) | 0.07 (-0.5 to 0.7) |
| microunits per liter | Exenatide | Placebo |
|---|---|---|
| Change in Insulin | 1.1 (-0.6 to 2.8) | 0.4 (-1.3 to 2.0) |
| mg/dl | Exenatide | Placebo |
|---|---|---|
| Change in Fasting Glucose | 0.5 (-3.6 to 4.5) | 3.1 (-0.7 to 7.0) |
| mg/dl | Exenatide | Placebo |
|---|---|---|
| Change in Two Hour Glucose | -10 (-21 to 1.2) | -0.5 (-11 to 10) |
| Ratio fasting glucose to insulin | Exenatide | Placebo |
|---|---|---|
| HOMA Score | 0.2 (-0.3 to 0.6) | 0.2 (-0.3 to 0.6) |
Resting Energy Expenditure
| Kilocalories | Exenatide | Placebo |
|---|---|---|
| REE | -13.7 (-60.6 to 33.2) | 6.5 (-38.0 to 51.0) |
Collected over 37 weeks. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| All Study Participants | 0/41 (0%) | 0/41 (0%) | 31/41 (75.6%) |
| Event | All Study Participants |
|---|---|
| NauseaGastrointestinal disorders | 31/41 |
| ConstipationGastrointestinal disorders | 2/41 |
| BloatingGastrointestinal disorders | 1/41 |
| Irritation at injection siteSkin and subcutaneous tissue disorders | 1/41 |
| FatigueGeneral disorders | 1/41 |
| HeartburnGastrointestinal disorders | 1/41 |
| DiarrheaGastrointestinal disorders | 1/41 |
| Age, Continuous(years) | All Study Participants |
|---|---|
| Mean | 48 ± 11 |
| Sex: Female, Male(Participants) | All Study Participants |
|---|---|
| Female | 41 |
| Male | 0 |
| Region of Enrollment(participants) | All Study Participants |
|---|---|
| United States | 41 |
| Weight(Kilograms) | All Study Participants |
|---|---|
| Mean | 89 ± 14 |
| BMI(Kg/meter^2) | All Study Participants |
|---|---|
| Mean | 33 ± 4 |
| HOMA IR(Ratio) | All Study Participants |
|---|---|
| Mean | 2 ± 1 |
| Waist(centrimeters) | All Study Participants |
|---|---|
| Mean | 105 ± 12 |
| Body Fat(percent) | All Study Participants |
|---|---|
| Mean | 40 ± 5 |
12 further baseline measures are reported on the registry.
This study is completed, as verified in Aug 2017. You cannot join it, but the record below documents what was studied.
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Beth Israel Deaconess Medical Center