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

Seoul National University

Status

Completed

Conditions

Diabetes Mellitus

Treatments

Other: Placebo

Drug: Lixisenatide

Study type

Interventional

Funder types

Other

Identifiers

NCT02745470

H-1507-038-686

Details and patient eligibility

About

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 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.

Enrollment

30 patients

Sex

All

Ages

19 to 70 years old

Volunteers

No 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