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Glucose-homeostasis After Endoscopic Sleeve Gastroplasty

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ClinicalTrials.gov Identifier: NCT04063098
Recruitment Status : Recruiting
First Posted : August 21, 2019
Last Update Posted : August 21, 2019
Sponsor:
Information provided by (Responsible Party):
University Hospital Inselspital, Berne

Brief Summary:
Endoscopic sleeve gastroplasty (ESG) is a transoral endoscopic procedure that creates a tubular sleeve along the lesser curvature with a gastric volume of approximately 30%. Summarizing the available literature published since its introduction in 2013, ESG was capable to achieve > 10% of sustained total body weight loss in a majority of mildly to moderately obese patients with the caveat of only minor adverse events. Besides weight loss, little is known about the metabolic effects of ESG. The present study seeks to measure markers of glucose homeostasis during oral glucose tolerance tests before and subsequently after application of ESG in 12 patients.

Condition or disease Intervention/treatment Phase
Obesity, Morbid Other: Oral glucose tolerance test Not Applicable

Detailed Description:

Endoscopic sleeve gastroplasty (ESG) is a transoral endoscopic procedure that utilizes full-thickness sutures extending from the prepyloric antrum to the gastroesophageal junction, creating a tubular sleeve along the lesser curvature with a gastric volume of approximately 30%. After the first feasibility study was available in 2013, multiple investigators published data on safety and efficacy of ESG. A recent meta analysis of novel endoscopic procedures revealed four observational studies on ESG. At 6, 12 and 24 months pooled excessive weight loss (EWL) was 52%, 53%, and 60% while pooled total body weight loss (TBWL) was 16%, 17%, and 20%, respectively.

Aside from its efficacy in terms of body weight loss, only a small number of investigations addressed metabolic changes in response to ESG so far. In a large retrospective analysis, which observed the outcomes of 1000 patients following ESG, 13 of 17 cases of type 2 diabetes mellitus (T2DM), all 28 cases of hypertension, and 18 of 32 cases of dyslipidemia were in complete remission by the third month of follow-up.

Summarizing the available literature, knowledge about effects of ESG on metabolism and glucose homeostasis is scarce. Available studies are subject to significant limitations in terms of sample size and or generalizability of results. The present study aims at a comprehensive determination of changes in hormonal regulators of glucose homeostasis after ESG in comparison to the preoperative state. Up to date, there are no structured and detailed analyses available that investigate glucose homeostasis following ESG. Proper glucose homeostasis yields a significant impact on a patients' quality of life and may - if deteriorated - be accompanied by a plethora of somatic and psychological constraints. The results of the present study seeks to investigate glucose homeostasis following ESG in detail. This may help to identify patients in need for further assistance regarding their post-interventional lifestyle in order to avoid e.g. hypoglycemia, and to further characterize patients' cohorts that will likely benefit from ESG.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 12 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Effects of Endoscopic Sleeve Gastroplasty on Hormonal Markers of Glucose-homeostasis
Estimated Study Start Date : August 30, 2019
Estimated Primary Completion Date : August 30, 2020
Estimated Study Completion Date : December 24, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endoscopy
Drug Information available for: Dextrose

Arm Intervention/treatment
All participants
Participants scheduled for endoscopic sleeve gastroplasty
Other: Oral glucose tolerance test
Oral glucose tolerance test (OGTT) after a 72-hours standardized diet. OGTT will be performed 1 month prior to as well as 1, 3, 6, and 12 months after endoscopic sleeve gastroplasty




Primary Outcome Measures :
  1. Area under the curve for plasma glucose in oral glucose tolerance test [ Time Frame: From time-point 0 to 120 minutes during oral glucose tolerance test, measurement every 15 minutes ]
    Plasma glucose will be measured in oral glucose tolerance test following dapagliflozin and will be compared with concentrations measured following placebo. Active and inactivated glucagon like peptide I will be measured.


Secondary Outcome Measures :
  1. Area under the curve for glucagon-like peptide I in oral glucose tolerance test [ Time Frame: From time-point 0 to 120 minutes during oral glucose tolerance test, measurement every 15 minutes ]
    Glucagon-like peptide I will be measured in oral glucose tolerance test following dapagliflozin and will be compared with concentrations measured following placebo. Active and inactivated glucagon like peptide I will be measured.

  2. Area under the curve for gastric inhibitory peptide in oral glucose tolerance test [ Time Frame: From time-point 0 to 120 minutes during oral glucose tolerance test, measurement every 15 minutes ]
    Gastric inhibitory peptide will be measured in oral glucose tolerance test following dapagliflozin and will be compared with concentrations measured following placebo. Active and inactivated glucagon like peptide I will be measured.

  3. Area under the curve for glucagon in oral glucose tolerance test [ Time Frame: From time-point 0 to 120 minutes during oral glucose tolerance test, measurement every 15 minutes ]
    Glucagon will be measured in oral glucose tolerance test

  4. Area under the curve for somatostatin in oral glucose tolerance test [ Time Frame: From time-point 0 to 120 minutes during oral glucose tolerance test, measurement every 15 minutes ]
    Somatostatin will be measured in oral glucose tolerance test

  5. Area under the curve for non-acyl ghrelin in oral glucose tolerance test [ Time Frame: From time-point 0 to 120 minutes during oral glucose tolerance test, measurement every 15 minutes ]
    Non-acyl Ghrelin will be measured in oral glucose tolerance test

  6. Area under the curve for insulin in oral glucose tolerance test [ Time Frame: From time-point 0 to 120 minutes during oral glucose tolerance test, measurement every 15 minutes ]
    Insulin will be measured in oral glucose tolerance test



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Planned ESG
  • Written informed consent
  • Male or female sex
  • Age 18-65 years
  • BMI ≥ 40 kg/m2 OR
  • BMI ≥ 35 kg/m2 and obesity-related comorbidities except type 2 diabetes

Exclusion Criteria:

  • Type 1 or Type 2 Diabetes
  • Type 2 Diabetes according to pathological OGTT at visit 2
  • Mandatory use of medical drugs that influence glucose metabolism
  • Participant had bariatric procedures other than ESG
  • Abdominal surgery influencing glucose metabolism
  • Moderate to severe chronic kidney, liver, or pancreatic disease
  • Pregnancy or breastfeeding
  • Physical or psychological disease likely to interfere with the normal conduct of the study and interpretation of the study results as judged by the investigator

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): NCT04063098


Contacts
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Contact: Markus Laimer, Prof. MD +41316323062 ext +41316323062 Markus.Laimer@insel.ch
Contact: Andreas Melmer, MD +41316323062 ext +41316323062 Andreas.Melmer@insel.ch

Locations
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Switzerland
Department of Diabetes, Endocrinology, Nutritional Medicine and Metabolism, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland Recruiting
Bern, Switzerland, 3010
Contact: Markus Laimer, Prof. MD    +41 31 63 2 30 62    Markus.Laimer@insel.ch   
Contact: Andreas Melmer, MD, PhD    +41 31 66 4 02 49    Andreas.Melmer@insel.ch   
Sponsors and Collaborators
University Hospital Inselspital, Berne
Investigators
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Principal Investigator: Markus Laimer, Prof. MD Department of Diabetes, Endocrinology, Clinical Nutrition and Metabolism, University Clinics Bern, Inselspital, Bern, Switzerland

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Responsible Party: University Hospital Inselspital, Berne
ClinicalTrials.gov Identifier: NCT04063098     History of Changes
Other Study ID Numbers: ESG_01
First Posted: August 21, 2019    Key Record Dates
Last Update Posted: August 21, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Obesity, Morbid
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms