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Trial record 53 of 61 for:    Lixisenatide

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

Tracking Information
First Submitted Date  ICMJE April 17, 2016
First Posted Date  ICMJE April 20, 2016
Last Update Posted Date November 29, 2017
Study Start Date  ICMJE February 2016
Actual Primary Completion Date December 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 17, 2016)
  • Difference of BOLD (Blood oxygenation level-dependent) signal in hypothalamus [ Time Frame: 10min (40 min after injection) ]
  • Whole brain connectivity [ Time Frame: 20min (50 min after injection) ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02745470 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 20, 2016)
  • appetite change [ Time Frame: -30min, 45min(after fMRI), 70min(after buffet) ]
    Visual analoge scale-questionnaire consisting of 8 questions (Flint, Raben, Blundell, & Astrup, 2000)
  • mood change [ Time Frame: -30min, 45min(after fMRI), 70min(after buffet) ]
    Visual analoge scale-questionnaire consisting of 16 questions (Boggieo et al., 2008)
  • 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 .
Original Secondary Outcome Measures  ICMJE
 (submitted: April 17, 2016)
  • appetite change [ Time Frame: -30min, 45min(after fMRI), 70min(after buffet) ]
    from survey
  • mood change [ Time Frame: -30min, 45min(after fMRI), 70min(after buffet) ]
    from survey
  • intake of food in the buffet [ Time Frame: 50min ]
    measurement of total food intake in the buffet
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effects of a GLP-1 Receptor Agonist on Functional Activation and Connectivity of the Brain
Official Title  ICMJE Effects of a GLP-1 Receptor Agonist on Functional Activation and Connectivity of the Brain Measured by Functional MRI
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
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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Basic Science
Condition  ICMJE Diabetes Mellitus
Intervention  ICMJE
  • Drug: Lixisenatide
    Colorless, transparent liquid contained in a glass prefilled syringe pen-like injection (GLP-1 receptor agonist)
    Other Name: Lyxumia® pen injection
  • Other: Placebo
    Normal saline injection before performing fMRI
    Other Name: Normal saline injection
Study Arms  ICMJE
  • Experimental: Lixisenatide injection
    intervention : Lyxumia® pen injection 10 microgram (Lixisenatide) subcutaneous injection 30 minutes before functional MRI
    Intervention: Drug: Lixisenatide
  • Placebo Comparator: Normal saline
    control : normal saline 0.3 cc subcutaneous injection before functional MRI
    Intervention: Other: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 17, 2016)
30
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2016
Actual Primary Completion Date December 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 19 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02745470
Other Study ID Numbers  ICMJE H-1507-038-686
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Seoul National University Hospital
Study Sponsor  ICMJE Seoul National University Hospital
Collaborators  ICMJE Seoul National University
Investigators  ICMJE
Study Chair: Young Min Cho, MD, PHD Associate Professor Division of Endocrinology and Metabolism Department of Internal Medicine Seoul National University College of Medicine
PRS Account Seoul National University Hospital
Verification Date February 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP