NCT02745470

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable diabetes-mellitus

Timeline
Completed

Started Feb 2016

Shorter than P25 for not_applicable diabetes-mellitus

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2016

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

April 17, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 20, 2016

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

November 29, 2017

Status Verified

February 1, 2016

Enrollment Period

10 months

First QC Date

April 17, 2016

Last Update Submit

November 27, 2017

Conditions

Diabetes Mellitus

Keywords

lean/obese diabetes mellitusfunctional MRIGLP-1appetiteactivation of brainconnectivity

Outcome Measures

Primary Outcomes (2)

  • Difference of BOLD (Blood oxygenation level-dependent) signal in hypothalamus

    10min (40 min after injection)

  • Whole brain connectivity

    20min (50 min after injection)

Secondary Outcomes (3)

  • appetite change

    -30min, 45min(after fMRI), 70min(after buffet)

  • mood change

    -30min, 45min(after fMRI), 70min(after buffet)

  • intake of food in the buffet

    50min

Study Arms (2)

Lixisenatide injection

EXPERIMENTAL

intervention : Lyxumia® pen injection 10 microgram (Lixisenatide) subcutaneous injection 30 minutes before functional MRI

Drug: Lixisenatide

Normal saline

PLACEBO COMPARATOR

control : normal saline 0.3 cc subcutaneous injection before functional MRI

Other: Placebo

Interventions

LixisenatideDRUG

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

Also known as: Lyxumia® pen injection
Lixisenatide injection
PlaceboOTHER

Normal saline injection before performing fMRI

Also known as: Normal saline injection
Normal saline

Eligibility Criteria

Age19 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • BMI ≤ 23kg/m2 or BMI ≥ 26kg/m2
  • participants with diabetes treated by diet or oral antidiabetic drug, HbA1c less than 8.5%

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Hospital

Seoul, 110-744, South Korea

Location

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

lixisenatideSaline Solution

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Crystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Study Officials

  • Young Min Cho, MD, PHD

    Associate Professor Division of Endocrinology and Metabolism Department of Internal Medicine Seoul National University College of Medicine

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 17, 2016

First Posted

April 20, 2016

Study Start

February 1, 2016

Primary Completion

December 1, 2016

Study Completion

December 1, 2016

Last Updated

November 29, 2017

Record last verified: 2016-02

Locations

KR(1)