- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01152333
The Role of GLP-1 in Satiety Perception in Humans
June 17, 2015 updated by: Ellen Schur, MD, MS, University of Washington
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.
Study Overview
Status
Withdrawn
Conditions
Intervention / Treatment
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 Type
Interventional
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Washington
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Seattle, Washington, United States, 98195
- University of Washington
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 29 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Exendin (9-39) Acetate
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.
|
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.
|
Placebo Comparator: Saline
Saline 0.9% will be used as the control infusion.
|
Saline will be administered through IV infusion once for a maximum of 2.5 hours in length
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Study 1 - Amount of food eaten at a lunch buffet
Time Frame: 1 year
|
1 year
|
Study 2 - BOLD response as measured by fMRI during viewing of food photographs
Time Frame: 1 year
|
1 year
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Study 1 - Patient-reported appetite and appeal ratings
Time Frame: 1 year
|
1 year
|
Study 2 - Amount of food eaten at a lunch buffet and self-reported appetite ratings
Time Frame: 1 year
|
1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Ellen A Schur, M.D., M.S., University of Washington
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2010
Primary Completion (Anticipated)
July 1, 2016
Study Completion (Anticipated)
July 1, 2016
Study Registration Dates
First Submitted
June 15, 2010
First Submitted That Met QC Criteria
June 25, 2010
First Posted (Estimate)
June 29, 2010
Study Record Updates
Last Update Posted (Estimate)
June 19, 2015
Last Update Submitted That Met QC Criteria
June 17, 2015
Last Verified
June 1, 2015
More Information
Terms related to this study
Other Study ID Numbers
- 37919-D
- 1R03DK083502-01A1 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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