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NCT Number: NCT04063098

Glucose-homeostasis After Endoscopic Sleeve Gastroplasty

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.

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Key information

Conditions

Obesity, Morbid Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Diabetes, Endocrinology, Nutritional Medicine and Metabolism, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland

Bern, 3010, Switzerland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Oral glucose tolerance test

Other

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 outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Insel Gruppe AG, University Hospital Bern

Other

Registry information

Official study title

Effects of Endoscopic Sleeve Gastroplasty on Hormonal Markers of Glucose-homeostasis

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Aug 21, 2019
Registry last updated
Apr 27, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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