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

Not Applicable

Completed

• Conditions: Diabetes Mellitus
• Interventions: Other: Placebo; Drug: Lixisenatide

• Registration Number: NCT02745470
• Lead Sponsor: Seoul National University Hospital

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.

Study Timeline

• Status Verified: 2016-02
• Study Start: 2016-02
• Study First Submitted: 2016-04-17
• Study First Submitted QC: 2016-04-17
• Study First Posted: 2016-04-20
• Primary Completion: 2016-12
• Study Completion: 2016-12
• Last Update Submitted: 2017-11-27
• Last Update Posted: 2017-11-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Normal saline	Placebo	control : normal saline 0.3 cc subcutaneous injection before functional MRI
Lixisenatide injection	Lixisenatide	intervention : Lyxumia® pen injection 10 microgram (Lixisenatide) subcutaneous injection 30 minutes before functional MRI

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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 .
mood change	-30min, 45min(after fMRI), 70min(after buffet)	Visual analoge scale-questionnaire consisting of 16 questions (Boggieo et al., 2008)
appetite change	-30min, 45min(after fMRI), 70min(after buffet)	Visual analoge scale-questionnaire consisting of 8 questions (Flint, Raben, Blundell, \& Astrup, 2000)

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of