DRUG
Lixisenatide
Colorless, transparent liquid contained in a glass prefilled syringe pen-like injection (GLP-1 receptor agonist)
Effects of a GLP-1 Receptor Agonist on Functional Activation and Connectivity of the Brain
Status
Completed
Phase
Not applicable
Enrollment
30
Locations
1
Results
Not posted
Publications
0
Study summary
What the protocol is testing.
The aims this study is to explore the effect of a GLP-1 receptor agonist on the degree of brain activation and connectivity obtained by functional magnetic resonance imaging in lean and obese type 2 diabetes
Full detailed description
Fifteen lean \[BMI(body mass index) less than 23 kg/m2\] type 2 diabetes subjects and fifteen obese (BMI more than 26 kg/m2) subjects with type 2 diabetes treated by diet and/or metformin, SU(sulfonylurea), DPP4-inhibitors(Dipeptidyl peptidase-4 inhibitor) will be recruited. Every subject will be studied on 2 separate days in random order with 1-2 week intervals. These participants will be injected either normal saline or 10 mcg of lixisenatide in a cross-over fashion. Neuroimaging composed with resting-12-min, visual stimulation task-12-min, T1-5-min, and diffusion tensor image-12-min will be proceeded. Ad lib buffet will be provided to every participant and the intake will be measured. Surveys about appetite and mood will be done before and after neuroimaging test and buffet eating.
Interventions
Treatment arms and agents.
OTHER
Placebo
Normal saline injection before performing fMRI
Timeline
From registration to results.
First posted
Apr 20, 2016
Study start
Feb 2016
Primary completion
Dec 2016
Study completion
Dec 2016
Results posted
Not reported
Registry updated
Nov 29, 2017
Outcomes
What the study measures.
Primary outcomes
Difference of BOLD (Blood oxygenation level-dependent) signal in hypothalamus
Time frame · 10min (40 min after injection)
Whole brain connectivity
Time frame · 20min (50 min after injection)
Secondary outcomes
appetite change
Time frame · -30min, 45min(after fMRI), 70min(after buffet)
Visual analoge scale-questionnaire consisting of 8 questions (Flint, Raben, Blundell, \& Astrup, 2000)
mood change
Time frame · -30min, 45min(after fMRI), 70min(after buffet)
Visual analoge scale-questionnaire consisting of 16 questions (Boggieo et al., 2008)
intake of food in the buffet
Time frame · 50min
It will be provided quantified juice and milk , boiled eggs, bread , bananas and chocolate bars. Participants may eat freely for 20 minutes. Then measure the intake of participants. Compares whether the difference in food intake pattern .
Eligibility
Who can take part.
- Minimum age
- 19 Years
- Maximum age
- 70 Years
- Sex
- ALL
- Healthy volunteers
- No
Inclusion Criteria: * BMI ≤ 23kg/m2 or BMI ≥ 26kg/m2 * participants with diabetes treated by diet or oral antidiabetic drug, HbA1c less than 8.5% Exclusion Criteria: * Those who diagnosed by Type 1 diabetes * History of insulin therapy * Aspartate aminotransferase(AST) or Alanine transaminase(ALT) \>2.5 times of upper normal reference range * Estimated Glomerular Filtration Rate(eGFR) \<30 mL/min/1.73m2 * Those who can't be performed MRI
Study locations
1 registered sites.
South Korea. Showing up to 24 locations stored in the fast local snapshot.
Seoul National University Hospital
Seoul, South Korea
Publications
Results and literature.
No PMID-linked publications were present in this registry snapshot.
Related trials
More studies on Lixisenatide.
NCT IDStudyPhase / statusEnrollmentUpdated
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Study to Evaluate the Effect of Lixisenatide in Patient With Parkinson's Disease
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Phase 3
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Related PeptideStat pages
Put the record in context.
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