NCT01152333

Brief 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. 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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jul 2010

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 15, 2010

Completed
14 days until next milestone

First Posted

Study publicly available on registry

June 29, 2010

Completed
2 days until next milestone

Study Start

First participant enrolled

July 1, 2010

Completed
6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2016

Completed
Last Updated

June 19, 2015

Status Verified

June 1, 2015

Enrollment Period

6 years

First QC Date

June 15, 2010

Last Update Submit

June 17, 2015

Conditions

Appetite RegulationObesity

Outcome Measures

Primary Outcomes (2)

  • Study 1 - Amount of food eaten at a lunch buffet

    1 year

  • Study 2 - BOLD response as measured by fMRI during viewing of food photographs

    1 year

Secondary Outcomes (2)

  • Study 1 - Patient-reported appetite and appeal ratings

    1 year

  • Study 2 - Amount of food eaten at a lunch buffet and self-reported appetite ratings

    1 year

Study Arms (2)

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.

Drug: Exendin-(9-39) Acetate

Saline

PLACEBO COMPARATOR

Saline 0.9% will be used as the control infusion.

Drug: Saline 0.9%

Interventions

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.

Exendin (9-39) Acetate
Saline 0.9%DRUG

Saline will be administered through IV infusion once for a maximum of 2.5 hours in length

Also known as: Sodium chloride (NaCl)
Saline

Eligibility Criteria

Age18 Years - 29 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Washington

Seattle, Washington, 98195, United States

Location

Related Publications (1)

  • 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.

    PMID: 25049134DERIVED

MeSH Terms

Conditions

Obesity

Interventions

exendin (9-39)Sodium Chloride

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

ChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium Compounds

Study Officials

  • Ellen A Schur, M.D., M.S.

    University of Washington

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Ellen A Schur, MD, MS

Study Record Dates

First Submitted

June 15, 2010

First Posted

June 29, 2010

Study Start

July 1, 2010

Primary Completion

July 1, 2016

Study Completion

July 1, 2016

Last Updated

June 19, 2015

Record last verified: 2015-06

Locations

US(1)