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Hormonal and Metabolic Aspects of Endoscopic Sleeve Gastroplasty

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ClinicalTrials.gov Identifier: NCT04452786
Recruitment Status : Recruiting
First Posted : June 30, 2020
Last Update Posted : June 30, 2020
Sponsor:
Information provided by (Responsible Party):
Nora Elisabeth Hedbäck, Hvidovre University Hospital

Tracking Information
First Submitted Date  ICMJE June 19, 2020
First Posted Date  ICMJE June 30, 2020
Last Update Posted Date June 30, 2020
Actual Study Start Date  ICMJE June 5, 2020
Estimated Primary Completion Date April 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 26, 2020)
Changes in ghrelin (pg/ml) [ Time Frame: 240 minutes ]
Changes in ghrelin after a solid meal test compared before and after surgery
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: June 26, 2020)
Changes in gut hormone response before and after sugery (pmol/L) [ Time Frame: 240 minutes ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Hormonal and Metabolic Aspects of Endoscopic Sleeve Gastroplasty
Official Title  ICMJE Hormonal and Metabolic Aspects of Endoscopic Sleeve Gastroplasty
Brief Summary The investigators of the study want to investigate the complex interactions between glucose metabolism, food intake/weight loss, and different appetite regulating hormones after ESG in comparison with conventional laparoscopic sleeve gastrectomy (LSG).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE
  • Endoscopic Sleeve Gastroplasty
  • Laparoscopic Sleeve Gastrectomy
  • Gut Hormones
  • Glucose Metabolism Disorders
Intervention  ICMJE
  • Procedure: Endoscopic sleeve gastroplasty
    Four-hour solid mixed meal test
  • Procedure: Laparoscopic sleeve gastrectomy
    Four-hour solid mixed meal test
Study Arms  ICMJE
  • Endoscopic sleeve gastroplasity operated patients
    Four test days, two days before surgery, one test day three months after surgery and one test day one year after surgery
    Intervention: Procedure: Endoscopic sleeve gastroplasty
  • Laparoscopic sleeve gastrectomy operated patients
    Four test days, two days before surgery, one test day three months after surgery and one test day one year after surgery
    Intervention: Procedure: Laparoscopic sleeve gastrectomy
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 Recruiting
Estimated Enrollment  ICMJE
 (submitted: June 26, 2020)
24
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE April 2023
Estimated Primary Completion Date April 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Age > 18 years
  • Scheduled for endoscopic or laparoscopic sleeve at Hvidovre Hospital
  • HbA1c < 48 mmol/mol before surgery, and no history of diabetes
  • HbA1c < 48 mmol/mol and fasting plasma glucose < 6.1 mmol/l at inclusion
  • BMI<45

Exclusion Criteria:

  • Hemoglobin < 6.5 mmol/l at inclusion
  • Pregnancy or breast feeding
  • Medication affecting the planned examinations
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Listed Location Countries  ICMJE Denmark
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04452786
Other Study ID Numbers  ICMJE H-19012015
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Nora Elisabeth Hedbäck, Hvidovre University Hospital
Study Sponsor  ICMJE Hvidovre University Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Hvidovre University Hospital
Verification Date June 2020

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