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

Diabetes Mellitus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02745470
• Other study ID #: H-1507-038-686
• Status: Completed
• Phase: N/A
• First received: April 17, 2016
• Last updated: November 27, 2017
• Start date: February 2016
• Est. completion date: December 2016

Study information

• Verified date: February 2016
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus

Intervention

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

Other:
• Placebo
Normal saline injection before performing fMRI

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (2)

Lead Sponsor	Collaborator
Seoul National University Hospital	Seoul National University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Difference of BOLD (Blood oxygenation level-dependent) signal in hypothalamus		10min (40 min after injection)
Primary	Whole brain connectivity		20min (50 min after injection)
Secondary	appetite change	Visual analoge scale-questionnaire consisting of 8 questions (Flint, Raben, Blundell, & Astrup, 2000)	-30min, 45min(after fMRI), 70min(after buffet)
Secondary	mood change	Visual analoge scale-questionnaire consisting of 16 questions (Boggieo et al., 2008)	-30min, 45min(after fMRI), 70min(after buffet)
Secondary	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 .	50min