Clinical trial NCT04063098: Glucose-homeostasis After Endoscopic Sleeve Gastroplasty
Official title: Effects of Endoscopic Sleeve Gastroplasty on Hormonal Markers of Glucose-homeostasis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity, Morbid
Lead sponsor: Insel Gruppe AG, University Hospital Bern
Sponsor class: OTHER
First posted: 2019-08-21
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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.

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.

Eligibility 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

Primary outcomes:
measure: Area under the curve for plasma glucose in oral glucose tolerance test
timeFrame: From time-point 0 to 120 minutes during oral glucose tolerance test, measurement every 15 minutes
Secondary outcomes:
measure: Area under the curve for glucagon-like peptide I in oral glucose tolerance test
timeFrame: From time-point 0 to 120 minutes during oral glucose tolerance test, measurement every 15 minutes
measure: Area under the curve for gastric inhibitory peptide in oral glucose tolerance test
timeFrame: From time-point 0 to 120 minutes during oral glucose tolerance test, measurement every 15 minutes
measure: Area under the curve for glucagon in oral glucose tolerance test
timeFrame: From time-point 0 to 120 minutes during oral glucose tolerance test, measurement every 15 minutes
measure: Area under the curve for somatostatin in oral glucose tolerance test
timeFrame: From time-point 0 to 120 minutes during oral glucose tolerance test, measurement every 15 minutes
measure: Area under the curve for non-acyl ghrelin in oral glucose tolerance test
timeFrame: From time-point 0 to 120 minutes during oral glucose tolerance test, measurement every 15 minutes
measure: Area under the curve for insulin in oral glucose tolerance test
timeFrame: From time-point 0 to 120 minutes during oral glucose tolerance test, measurement every 15 minutes
Other outcomes:
Locations:
city: Bern
country: Switzerland
facility: Department of Diabetes, Endocrinology, Nutritional Medicine and Metabolism, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland
Study officials:
affiliation: Department of Diabetes, Endocrinology, Clinical Nutrition and Metabolism, University Clinics Bern, Inselspital, Bern, Switzerland
name: Markus Laimer, Prof. MD
role: PRINCIPAL_INVESTIGATOR
References: