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Completed

NCT Number: NCT02745470

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

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

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Key information

Conditions

Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

19 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Seoul National University Hospital

Seoul, 110-744, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lixisenatide

Drug

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

Other names: Lyxumia® pen injection

Placebo

Other

Normal saline injection before performing fMRI

Other names: Normal saline injection

Primary outcomes

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

    Time frame: 10min (40 min after injection)

  2. Whole brain connectivity

    Time frame: 20min (50 min after injection)

Secondary outcomes

  1. appetite change

    Time frame: -30min, 45min(after fMRI), 70min(after buffet)

    Visual analoge scale-questionnaire consisting of 8 questions (Flint, Raben, Blundell, & Astrup, 2000)

  2. mood change

    Time frame: -30min, 45min(after fMRI), 70min(after buffet)

    Visual analoge scale-questionnaire consisting of 16 questions (Boggieo et al., 2008)

  3. 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 .

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Collaborators

  • Seoul National University

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Apr 20, 2016
Registry last updated
Nov 29, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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