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

November 27, 2017 updated by: Seoul National University Hospital

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of, 110-744
        • Seoul National University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Lixisenatide injection
intervention : Lyxumia® pen injection 10 microgram (Lixisenatide) subcutaneous injection 30 minutes before functional MRI
Drug: Lixisenatide
Colorless, transparent liquid contained in a glass prefilled syringe pen-like injection (GLP-1 receptor agonist)
Other Names:
  • Lyxumia® pen injection
Placebo Comparator: Normal saline
control : normal saline 0.3 cc subcutaneous injection before functional MRI
Other: Placebo
Normal saline injection before performing fMRI
Other Names:
  • Normal saline injection

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
appetite change
Time Frame: -30min, 45min(after fMRI), 70min(after buffet)
Visual analoge scale-questionnaire consisting of 8 questions (Flint, Raben, Blundell, & Astrup, 2000)
-30min, 45min(after fMRI), 70min(after buffet)
mood change
Time Frame: -30min, 45min(after fMRI), 70min(after buffet)
Visual analoge scale-questionnaire consisting of 16 questions (Boggieo et al., 2008)
-30min, 45min(after fMRI), 70min(after buffet)
intake of food in the buffet
Time Frame: 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 .
50min

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Hospital

Collaborators

Seoul National University

Investigators

  • Study Chair: Young Min Cho, MD, PHD, Associate Professor Division of Endocrinology and Metabolism Department of Internal Medicine Seoul National University College of Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2016

Primary Completion (Actual)

December 1, 2016

Study Completion (Actual)

December 1, 2016

Study Registration Dates

First Submitted

April 17, 2016

First Submitted That Met QC Criteria

April 17, 2016

First Posted (Estimate)

April 20, 2016

Study Record Updates

Last Update Posted (Actual)

November 29, 2017

Last Update Submitted That Met QC Criteria

November 27, 2017

Last Verified

February 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H-1507-038-686

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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