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

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ClinicalTrials.gov Identifier: NCT02745470
Recruitment Status : Completed
First Posted : April 20, 2016
Last Update Posted : November 29, 2017
Sponsor:
Collaborator:
Seoul National University
Information provided by (Responsible Party):
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

Condition or disease Intervention/treatment Phase
Diabetes Mellitus Drug: Lixisenatide Other: Placebo Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Basic Science
Official Title: Effects of a GLP-1 Receptor Agonist on Functional Activation and Connectivity of the Brain Measured by Functional MRI
Study Start Date : February 2016
Actual Primary Completion Date : December 2016
Actual Study Completion Date : December 2016

Resource links provided by the National Library of Medicine


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 Name: 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 Name: Normal saline injection




Primary Outcome Measures :
  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 Outcome Measures :
  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 .




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Ages Eligible for Study:   19 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02745470


Locations
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Korea, Republic of
Seoul National University Hospital
Seoul, Korea, Republic of, 110-744
Sponsors and Collaborators
Seoul National University Hospital
Seoul National University
Investigators
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Study Chair: Young Min Cho, MD, PHD Associate Professor Division of Endocrinology and Metabolism Department of Internal Medicine Seoul National University College of Medicine

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Responsible Party: Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT02745470     History of Changes
Other Study ID Numbers: H-1507-038-686
First Posted: April 20, 2016    Key Record Dates
Last Update Posted: November 29, 2017
Last Verified: February 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Seoul National University Hospital:
lean/obese diabetes mellitus
functional MRI
GLP-1
appetite
activation of brain
connectivity

Additional relevant MeSH terms:
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Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Glucagon-Like Peptide 1
Lixisenatide
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Hypoglycemic Agents