ObesityPhase 4NCT00456885
The Effect of Exenatide on Weight and Hunger in Obese, Healthy Women
A Phase 4 study testing exenatide in people with Obesity and Impaired Glucose Tolerance, run by Beth Israel Deaconess Medical Center at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 25 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Obesity, Impaired Glucose Tolerance
- What is being tested?
- exenatide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 41 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2007to Sep 2010
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 60 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Females aged 25-60
- BMI 28-35 kg/m2
- No known diagnosis of diabetes
- No known diagnosis of coronary heart disease
- Self-described sedentary lifestyle with minimal regular cardiovascular exercise (no more than 1 hour per week)
- Stable weight (variation < 3 kg within 6 months of screening visit)
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- Ability to give informed consent
- Ability to follow verbal and written instructions
- Use of medically approved form of contraception (monophasic oral contraception, intra uterine device, surgical sterilization or 2 combined barrier methods)
- Nonsmoker (tobacco, marijuana)
- Outpatient visits every 2 weeks throughout the study period are required. While most of these visits are short (15 minutes)ability to commute to the performance site in Boston, on a regular basis, is necessary.
Who cannot join
- Type 1 or type 2 diabetes mellitus diagnosed according to American Diabetes Association criteria
- Coronary heart disease (history of myocardial infarction or unstable angina pectoris)
- Uncontrolled hypertension hypertension (BP > 150/90 mmHg on or off antihypertensive medication)
- Uncontrolled dyslipidemia (LDL > 200 or TG > 400 on or off lipid lowering medication)
- Tobacco, marijuana or intravenous drug use
- Shift workers (night shift or alternating day/night shifts)
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- Recent weight loss (> 3 kg within 4 months of the screening visit)
- Gastroparesis
- Inflammatory bowel disease
- Malignancy treated with chemotherapy within the past 3 years
- History of pancreatitis
- Depression requiring hospitalization or diagnosis of psychosis
- Renal insufficiency (creatinine clearance < 50 ml/min)
- Transaminases > 2x above the normal range
- Pregnancy within 6 months of the screening visit
- Breastfeeding
- Failure to use medically approved contraceptive methods
- History of an eating disorder (anorexia, bulimia or laxative abuse)
- History of surgery for the treatment of obesity (gastric banding, gastric bypass, gastric stapling)
- New diagnosis of hypo or hyperthyroidism within 1 year of screening visit
- Previous participation in a clinical study with exenatide
- Presence or history of allergic reaction to multiple drugs
Trial locations and contacts
1 site in 1 country.
United States1 site
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
About this study
Official title: The Effect of Exenatide on Body Weight, Energy Expenditure and Hunger in Obese Women Without Diabetes Mellitus
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.
Read the detailed description
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.
- Conditions
- Obesity, Impaired Glucose Tolerance
- Being tested
- exenatide, Placebo
- Keywords
- obesity, double blind, placebo controlled, weight loss, appetite, energy expenditure
- Medical subject headings
- Obesity, Glucose Intolerance, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
exenatideDrug
Also called Byetta
5 microgram twice a day for two week and then 10 mcg for remaining 15 weeks
PlaceboDrug
Twice daily injection of placebo
| Study group | Role | What they receive |
|---|---|---|
| Exenatide First | Placebo comparator | Started on Exenatide, 3 week washout, start placebo Receives: Drug: exenatide; Drug: Placebo |
| Placebo First | Experimental | Started on placebo, 3 week washout, start exenatide Receives: Drug: exenatide; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Weight
Change in weight at the end of each treatment period.
Measured: 16 weeks after the beginning of each treatment
Change in Body Mass Index
Measured: 16 weeks from the start of each treatment period.
Secondary outcomes (11)
Change in Waist Circumference
Measured: 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.
Measured: 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.
Measured: 16 weeks after the beginning of each treatment
Changes in Leptin
Measured: 16 weeks from the start of each treatment period.
Diastolic Blood Pressure
Measured: 16 weeks after the beginning of each treatment
Adiponectin
Measured: 16 weeks after the beginning of each treatment
Change in Insulin
Measured: 16 weeks from the start of each treatment period.
Change in Fasting Glucose
Measured: 16 weeks from the start of each treatment period.
Change in Two Hour Glucose
Measured: 16 weeks from the start of each treatment period.
HOMA Score
Measured: 16 weeks from the start of each treatment period.
REE
Resting Energy Expenditure
Measured: 16 weeks from the start of each treatment period.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2007 (estimated)
- Study startApr 2007
- Primary completionSep 2010
- Study completionSep 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Beth Israel Deaconess Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beth Israel Deaconess Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Amylin Pharmaceuticals, LLC., Eli Lilly and Company
- Responsible party
- Principal investigator, Eleftheria Maratos-Flier, Beth Israel Deaconess Medical Center
- Investigators
- Eleftheria Maratos-Flier, MD, Principal investigator, Beth Israel Deaconess Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00456885
- Sponsor's protocol ID
- 2006P000361
- Other IDs
- BFA912
- Status last verified
- Aug 2017
- First submitted
- 4 Apr 2007
- Last updated
- 11 Sep 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Dushay J, Gao C, Gopalakrishnan GS, Crawley M, Mitten EK, Wilker E, Mullington J, Maratos-Flier E. Short-term exenatide treatment leads to significant weight loss in a subset of obese women without diabetes. Diabetes Care. 2012 Jan;35(1):4-11. doi: 10.2337/dc11-0931. Epub 2011 Oct 31.
PubMed 22040840
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Exenatide on Body Weight, Energy Expenditure and Hunger in Obese Women Without Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT00456885
- Acronym / sponsor ID
- 2006P000361
- Conditions
- Obesity, Impaired Glucose Tolerance
- Keywords
- obesity, double blind, placebo controlled, weight loss, appetite, energy expenditure
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Beth Israel Deaconess Medical CenterUniversity, hospital or other
- Collaborators
- Amylin Pharmaceuticals, LLC., Eli Lilly and Company
- Study start
- Apr 2007
- Primary completion
- Sep 2010 (actual)
- Study completion
- Sep 2010 (actual)
- First posted
- 5 Apr 2007 (estimated)
- Results
- Posted 11 Sep 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exenatide First | Placebo comparator | Drug: exenatide, Drug: PlaceboStarted on Exenatide, 3 week washout, start placebo |
| Placebo First | Experimental | Drug: exenatide, Drug: PlaceboStarted on placebo, 3 week washout, start exenatide |
Who may qualify
- Ages
- 25 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- Females aged 25-60
- BMI 28-35 kg/m2
- No known diagnosis of diabetes
- No known diagnosis of coronary heart disease
- Self-described sedentary lifestyle with minimal regular cardiovascular exercise (no more than 1 hour per week)
Key exclusion criteria (22 listed)
- Type 1 or type 2 diabetes mellitus diagnosed according to American Diabetes Association criteria
- Coronary heart disease (history of myocardial infarction or unstable angina pectoris)
- Uncontrolled hypertension hypertension (BP > 150/90 mmHg on or off antihypertensive medication)
- Uncontrolled dyslipidemia (LDL > 200 or TG > 400 on or off lipid lowering medication)
- Tobacco, marijuana or intravenous drug use
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| exenatideAlso: Byetta5 microgram twice a day for two week and then 10 mcg for remaining 15 weeks | Drug | Exenatide First, Placebo First |
| PlaceboTwice daily injection of placebo | Drug | Exenatide First, Placebo First |
Primary outcome
Change in Weight
Time frame: 16 weeks after the beginning of each treatment
Change in weight at the end of each treatment period.
Change in Body Mass Index
Time frame: 16 weeks from the start of each treatment period.
11 secondary outcomes
Change in Waist Circumference
Time frame: 16 weeks from the start of each treatment period.
Systolic Blood Pressure
Time frame: 16 weeks after the beginning of each treatment
Changes in Body Composition
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
Time frame: 16 weeks from the start of each treatment period.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 22040840Dushay J, Gao C, Gopalakrishnan GS, Crawley M, Mitten EK, Wilker E, Mullington J, Maratos-Flier E. Short-term exenatide treatment leads to significant weight loss in a subset of obese women without diabetes. Diabetes Care. 2012 Jan;35(1):4-11. doi: 10.2337/dc11-0931. Epub 2011 Oct 31.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eleftheria Maratos-Flier, MD principal investigator
Beth Israel Deaconess Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing exenatide in people with Obesity and Impaired Glucose Tolerance, run by Beth Israel Deaconess Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 Sep 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Weight (time frame: 16 weeks after the beginning of each treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00456885, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2017.