Effects of a GLP-1 Receptor Agonist on Functional Activation and Connectivity of the Brain

Effects of a GLP-1 Receptor Agonist on Functional Activation and Connectivity of the Brain Measured by Functional MRI

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02745470

Enrollment

Registered

2016-04-20

Start date

2016-02-29

Completion date

2016-12-31

Last updated

2017-11-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus

Keywords

lean/obese diabetes mellitus, functional MRI, GLP-1, appetite, activation of brain, connectivity

Brief summary

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

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

DRUGLixisenatide

Colorless, transparent liquid contained in a glass prefilled syringe pen-like injection (GLP-1 receptor agonist)

OTHERPlacebo

Normal saline injection before performing fMRI

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

BASIC_SCIENCE

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

19 Years to 70 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Difference of BOLD (Blood oxygenation level-dependent) signal in hypothalamus	10min (40 min after injection)
Whole brain connectivity	20min (50 min after injection)

Secondary

Measure	Time frame	Description
appetite change	-30min, 45min(after fMRI), 70min(after buffet)	Visual analoge scale-questionnaire consisting of 8 questions (Flint, Raben, Blundell, & Astrup, 2000)
mood change	-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	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 .

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026