Appetite RegulationNCT01152333
The Role of GLP-1 in Satiety Perception in Humans
A study testing Exendin-(9-39) Acetate and Saline 0.9% in people with Appetite Regulation and Obesity, run by University of Washington at 1 site in United States.
Trial summary
Scientists have discovered a number of hormones that control our feelings of hunger and fullness. One particular hormone, called GLP-1, has been associated with feelings of hunger and fullness. Read more about this study
- Who is it for?
- Ages 18 to 29 yearsHealthy volunteers can take part
- Conditions the study is for
- Appetite Regulation, Obesity
- What is being tested?
- Exendin-(9-39) Acetate and Saline 0.9%
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2010to Jul 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 to 29 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male or female between 18-29 years of age
- BMI between 18.5-24.9 kg/m2
- Written informed consent obtained from subject and ability for subject to comply with the requirements of the study.
Who cannot join
- Chronic health conditions, including diabetes and kidney disease.
- Current dieting for weight loss or restrained eating
- History of obesity, eating disorders, or weight loss surgery
- Random blood glucose >140
- Pregnancy or use of oral contraceptives
- Current smoker
Show all 11Show fewer
- Recreational drug use or alcohol use of > 1 drink per day for females, > 2 per day for males
- Food allergy or intolerance to study foods.
- Medications known to alter appetite (e.g., amphetamines, atypical antipsychotics) or gastric emptying (e.g., metoclopromide)
- Contraindications to MRI, such as implanted metal or claustrophobia.
- Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data.
Trial locations and contacts
1 site in 1 country.
About this study
Scientists have discovered a number of hormones that control our feelings of hunger and fullness. One particular hormone, called GLP-1, has been associated with feelings of hunger and fullness. The overall purpose of this study is to look more closely at how GLP-1 changes these feelings and to observe how these hormones affect the brain's function. To do this, volunteers will be asked to come to the clinic for a screening visit, and 2 study visits. This is an outpatient study with a screening visit which will last about an hour and the two subsequent study visits for about 3 hours each. During the study, patients will receive a drug that blocks the effect of a hormone made in the gut. We will take a series of blood samples to measure hormones and use functional magnetic resonance imaging (MRI) to take pictures of the brain. Understanding the action of these hormones in the brain may eventually lead to new ways to help people avoid obesity or lose weight.
Read the detailed description
Many times each day, we see food or representations of food and evaluate whether or not the food looks good to us. If it does, we then balance external factors, such as the social situation or time of day, against internal signals about our hunger state in order to decide what and when to eat. However, recent functional magnetic resonance imaging (fMRI) studies suggest that internal signals, such as hormones regulating appetite and satiety, govern our food intake in part by acting on neural circuits to affect whether a given food appears appetizing at that moment. In addition, photographs of food perceived to be "fattening" activate brain regions involved in appetite and reward processing, including the hypothalamus, nucleus accumbens, and orbital frontal cortex. This activity is potently reduced by food intake, suggesting that it reflects underlying brain mechanisms involved in satiety. We now propose to study the mechanism of these changes in brain activity by asking if they are directly related to the action of glucagon-like peptide-1 (GLP-1), a satiety signal. GLP-1 is released by cells in the gut in response to nutrients, suppressing food intake, and its actions can be blocked by a GLP-1 receptor antagonist, exendin-[9-39]. In 2 randomized, controlled, crossover studies, we will assess whether exendin-[9-39] infusions reverse GLP-1-mediated effects on food intake and on brain response to visual food cues. Our scientific aims are to 1) observe the effect of exendin (9-39) on blocking GLP-1-mediated satiety in humans and assess its effect on food intake in humans for the first time (to our knowledge) and 2) to test whether endogenous GLP-1 signaling is required for the effect of a meal to reduce brain response to visual food cues in humans. We hypothesize that exendin-[9-39] will diminish the effect of a meal in suppressing subsequent food intake and in reducing activation to visual food cues in reward pathways. Determining the extent to which the experience of satiety arises from a decrease in the reward value of food is fundamentally important to understanding human feeding behavior. In addition, this promising line of research is directly relevant to some of the most pressing public health issues of our time: obesity and overnutrition. We hope that investigating mechanisms affecting our perception of satiety at the most basic level will eventually result in novel behavioral or pharmacologic strategies for obesity prevention and treatment.
- Conditions
- Appetite Regulation, Obesity
- Being tested
- Exendin-(9-39) Acetate, Saline 0.9%
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exendin-(9-39) AcetateDrug
Exendin (9-39) will be diluted in saline 0.9% and administered through IV infusion once for a maximum of 2.5 hours in length.
Saline 0.9%Drug
Also called Sodium chloride (NaCl)
Saline will be administered through IV infusion once for a maximum of 2.5 hours in length
| Study group | Role | What they receive |
|---|---|---|
| Exendin (9-39) Acetate | Active comparator | Exendin (9-39) is a synthetic peptide that acts as an antagonist to the GLP-1 receptor. Exendin (9-39) will be diluted in saline 0.9% and administered through IV infusion once for a maximum of 2.5 hours in length at 600-750 pM/kg/min. Receives: Drug: Exendin-(9-39) Acetate |
| Saline | Placebo comparator | Saline 0.9% will be used as the control infusion. Receives: Drug: Saline 0.9% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Study 1 - Amount of food eaten at a lunch buffet
Measured: 1 year
Study 2 - BOLD response as measured by fMRI during viewing of food photographs
Measured: 1 year
Secondary outcomes (2)
Study 1 - Patient-reported appetite and appeal ratings
Measured: 1 year
Study 2 - Amount of food eaten at a lunch buffet and self-reported appetite ratings
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2010 (estimated)
- Study startJul 2010
- Primary completionJul 2016 (estimated)
- Study completionJul 2016 (estimated)
Why it stopped: This study is delayed. It was not funded.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Appetite RegulationStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe 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 N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- Fred Hutchinson Cancer Center
- Responsible party
- Principal investigator, Ellen Schur, MD, MS, University of Washington
- Investigators
- Ellen A Schur, M.D., M.S., Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01152333
- Sponsor's protocol ID
- 37919-D
- Other IDs
- 1R03DK083502-01A1
- Status last verified
- Jun 2015
- First submitted
- 15 Jun 2010
- Last updated
- 19 Jun 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Melhorn SJ, Tyagi V, Smeraglio A, Roth CL, Schur EA. Initial evidence that GLP-1 receptor blockade fails to suppress postprandial satiety or promote food intake in humans. Appetite. 2014 Nov;82:85-90. doi: 10.1016/j.appet.2014.07.009. Epub 2014 Jul 15.
PubMed 25049134
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of GLP-1 in Satiety Perception in Humans
- ClinicalTrials.gov ID
- NCT01152333
- Acronym / sponsor ID
- 37919-D
- Conditions
- Appetite Regulation, Obesity
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: This study is delayed. It was not funded.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- Fred Hutchinson Cancer Center
- Study start
- Jul 2010
- Primary completion
- Jul 2016 (estimated)
- Study completion
- Jul 2016 (estimated)
- First posted
- 29 Jun 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Scientists have discovered a number of hormones that control our feelings of hunger and fullness. One particular hormone, called GLP-1, has been associated with feelings of hunger and fullness. The overall purpose of this study is to look more closely at how GLP-1 changes these feelings and to observe how these hormones affect the brain's function. To do this, volunteers will be asked to come to the clinic for a screening visit, and 2 study visits. This is an outpatient study with a screening visit which will last about an hour and the two subsequent study visits for about 3 hours each. During the study, patients will receive a drug that blocks the effect of a hormone made in the gut. We will take a series of blood samples to measure hormones and use functional magnetic resonance imaging (MRI) to take pictures of the brain. Understanding the action of these hormones in the brain may eventually lead to new ways to help people avoid obesity or lose weight.
Detailed description
Many times each day, we see food or representations of food and evaluate whether or not the food looks good to us. If it does, we then balance external factors, such as the social situation or time of day, against internal signals about our hunger state in order to decide what and when to eat. However, recent functional magnetic resonance imaging (fMRI) studies suggest that internal signals, such as hormones regulating appetite and satiety, govern our food intake in part by acting on neural circuits to affect whether a given food appears appetizing at that moment. In addition, photographs of food perceived to be "fattening" activate brain regions involved in appetite and reward processing, including the hypothalamus, nucleus accumbens, and orbital frontal cortex. This activity is potently reduced by food intake, suggesting that it reflects underlying brain mechanisms involved in satiety. We now propose to study the mechanism of these changes in brain activity by asking if they are directly related to the action of glucagon-like peptide-1 (GLP-1), a satiety signal. GLP-1 is released by cells in the gut in response to nutrients, suppressing food intake, and its actions can be blocked by a GLP-1 receptor antagonist, exendin-[9-39]. In 2 randomized, controlled, crossover studies, we will assess whether exendin-[9-39] infusions reverse GLP-1-mediated effects on food intake and on brain response to visual food cues. Our scientific aims are to 1) observe the effect of exendin (9-39) on blocking GLP-1-mediated satiety in humans and assess its effect on food intake in humans for the first time (to our knowledge) and 2) to test whether endogenous GLP-1 signaling is required for the effect of a meal to reduce brain response to visual food cues in humans. We hypothesize that exendin-[9-39] will diminish the effect of a meal in suppressing subsequent food intake and in reducing activation to visual food cues in reward pathways. Determining the extent to which the experience of satiety arises from a decrease in the reward value of food is fundamentally important to understanding human feeding behavior. In addition, this promising line of research is directly relevant to some of the most pressing public health issues of our time: obesity and overnutrition. We hope that investigating mechanisms affecting our perception of satiety at the most basic level will eventually result in novel behavioral or pharmacologic strategies for obesity prevention and treatment.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exendin (9-39) Acetate | Active comparator | Drug: Exendin-(9-39) AcetateExendin (9-39) is a synthetic peptide that acts as an antagonist to the GLP-1 receptor. Exendin (9-39) will be diluted in saline 0.9% and administered through IV infusion once for a maximum of 2.5 hours in length at 600-750 pM/kg/min. |
| Saline | Placebo comparator | Drug: Saline 0.9%Saline 0.9% will be used as the control infusion. |
Who may qualify
- Ages
- 18 to 29 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Male or female between 18-29 years of age
- BMI between 18.5-24.9 kg/m2
- Written informed consent obtained from subject and ability for subject to comply with the requirements of the study.
Key exclusion criteria (11 listed)
- Chronic health conditions, including diabetes and kidney disease.
- Current dieting for weight loss or restrained eating
- History of obesity, eating disorders, or weight loss surgery
- Random blood glucose >140
- Pregnancy or use of oral contraceptives
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 |
|---|---|---|
| Exendin-(9-39) AcetateExendin (9-39) will be diluted in saline 0.9% and administered through IV infusion once for a maximum of 2.5 hours in length. | Drug | Exendin (9-39) Acetate |
| Saline 0.9%Also: Sodium chloride (NaCl)Saline will be administered through IV infusion once for a maximum of 2.5 hours in length | Drug | Saline |
Primary outcome
Study 1 - Amount of food eaten at a lunch buffet
Time frame: 1 year
Study 2 - BOLD response as measured by fMRI during viewing of food photographs
Time frame: 1 year
2 secondary outcomes
Study 1 - Patient-reported appetite and appeal ratings
Time frame: 1 year
Study 2 - Amount of food eaten at a lunch buffet and self-reported appetite ratings
Time frame: 1 year
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jun 2015.
- Derived from this study: PubMed 25049134Melhorn SJ, Tyagi V, Smeraglio A, Roth CL, Schur EA. Initial evidence that GLP-1 receptor blockade fails to suppress postprandial satiety or promote food intake in humans. Appetite. 2014 Nov;82:85-90. doi: 10.1016/j.appet.2014.07.009. Epub 2014 Jul 15.
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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.
Ellen A Schur, M.D., M.S. principal investigator
University of Washington
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exendin-(9-39) Acetate and Saline 0.9% in people with Appetite Regulation and Obesity, run by University of Washington 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 3 inclusion and 11 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: withdrawn, as of the sponsor's last update on 19 Jun 2015. 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.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Study 1 - Amount of food eaten at a lunch buffet (time frame: 1 year). 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 NCT01152333, 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 19 Jun 2015.