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

Seoul National University Hospital30 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

SINGLE

Enrollment

Conditions

Diabetes Mellitus

Interventions

LixisenatideDRUG

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

PlaceboOTHER

Normal saline injection before performing fMRI

Eligibility

Sex: ALLMin age: 19 YearsMax age: 70 Years

Medical Language ↔ Plain English

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

Locations (1)

Seoul National University Hospital

Seoul, South Korea

Outcomes

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

Visual analoge scale-questionnaire consisting of 8 questions (Flint, Raben, Blundell, \& Astrup, 2000)

Time frame: -30min, 45min(after fMRI), 70min(after buffet)

mood change

Visual analoge scale-questionnaire consisting of 16 questions (Boggieo et al., 2008)

Time frame: -30min, 45min(after fMRI), 70min(after buffet)

intake of food in the buffet

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 .

Time frame: 50min

Data from ClinicalTrials.gov

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