Physiological Effects of Gastric Sleeve Operation

Effect of Gastric Sleeve Operation on Absorption and Metabolism of Glucose and Protein as Well as Gut-hormonal Response - A Comparison With Roux-en-Y Gastric Bypass

After gastric sleeve patients undergo a substantial weight loss, but the physiological mechanisms behind the weight loss is not fully elucidated. Studies suggest that gut-hormone secretion is altered comparable to what is also seen after Roux-en-Y gastric bypass, however to which extent is not fully established and furthermore, the mechanisms behind an altered secretion are unclear. The purpose of this study is to investigate absorption and postprandial metabolism of glucose and protein in addition to gut hormonal responses after gastric sleeve compared with a group of un-operated subjects machted on sex, age and BMI. Furter, a group of Roux-en-Y gastric bypass operated patients matched on pre-operative BMI, current BMI, sex and age will be included for comparison.

Study Overview

• Status: Completed
• Conditions: Obesity, Morbid; Bariatric Surgery
• Intervention / Treatment: Diagnostic test: Mixed meal test with double tracer technique

• Study Type: Observational
• Enrollment (Actual): 36

Contacts and Locations

Study Locations

• Denmark
  • Please Select
    • Hvidovre, Please Select, Denmark, 2650
      • Hvidovre University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 60 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients, who have undergone Roux-en-Y gastric bypass OR gastric sleeve operation > 12 month prior to inclusion.

Matched un-operated control subjects.

Description

SG ang RYGB group:

Inclusion Criteria:

• Uncomplicated RYGB or SG > 12 month prior to inclusion
• Weight stable (+/- 3 month the last month)
• Written informed consent

Exclusion Criteria:

• Diabetes (HbA1c>48 or Fasting plasma-glucose>6.1 mM)
• Pregnancy and/or breastfeeding
• Inadequately treated thyroid disease
• Serious heart or respiratory illness
• Haemoglobin < 6,5 mM.

Un-operated control group:

Inclusion Criteria:

• Written informed consent

Exclusion Criteria:

• Prior RYGB, SG or complicated upper gastrointestinal surgery
• Diabetes (HbA1c>48 or Fasting plasma-glucose>6.1 mM)
• Pregnancy and/or breastfeeding
• Inadequately treated thyroid disease
• Serious heart or respiratory illness
• Haemoglobin < 6,5 mM.

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Gastric sleeve operated subjects; 12 patients who have undergone gastric sleeve operation >12 month prior to inclution.	Diagnostic test: Mixed meal test with double tracer technique
Control Subjects; 12 Healthy un-operated control subjects matched to the gastric sleeve group in a one to one manner with respect to BMI, sex and age	Diagnostic test: Mixed meal test with double tracer technique
Gastric bypass operated subjects; 12 patients, who have undergone Roux-en-Y gastric bypass >12 month prior to inclution, matched to the gastric sleeve group in a one to one manner with respect to pre-operative BMI, post-operative BMI, sex and age.	Diagnostic test: Mixed meal test with double tracer technique

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Glucose absorption	Between groups difference in peak Rate of appearance (Ra) of oral glucose tracer SG vs. CON	0 - 360 minutes
Protein absorption	Between groups difference in peak Ra of oral aminoacid tracer SG vs. CON	0 - 360 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Glucose absorption	Between group difference in peak Ra of oral glucose comparing SG vs. RYGB	0 - 360 minutes
Protein absorption	Between groups differences in peak Ra of oral aminoacid tracer comparing SG vs. RYGB	0 - 360 minutes
Glucose kinetics	Between groups differences in AUC Ra of oral glucose tracer	0 - 360 minutes
Protein kinetics	Between groups differences in AUC Ra of oral aminoacid tracer	0 - 360 minutes
Insulin secretion	Between groups differences in iAUC of serum insulin and C-peptide	0 - 240 minutes
Glucagon-like Peptide 1 (GLP-1) secretion	Between groups differences in iAUC of plasma concentration of GLP-1	0 - 240 minutes
Glucose-dependent Insulinotropic Peptide (GIP)	Between groups differences in iAUC of plasma concentration of GIP	0 - 240 minutes
Ghrelin secretion	Between groups differences in iAUC of plasma concentration of ghrelin	0 - 240 minutes
Glucagon secretion	Between groups differences in iAUC of plasma cncentration of glucagon	0-240 minutes
Peptide YY	Between groups differences in iAUC of plasma concentration of PYY	0-240 minutes
Endogenous glucose production	Calculated via double tracer tecnique both in the fasting and post prandial state.	-120 - 360 minutes
Lipolysis	Between groups differences in Rate of Disappearance of glycerol tracer.	-120 - 360

Collaborators and Investigators

• Sponsor: Hvidovre University Hospital
• Collaborators: University of Copenhagen

Publications and helpful links

General Publications

• Svane MS, Bojsen-Moller KN, Martinussen C, Dirksen C, Madsen JL, Reitelseder S, Holm L, Rehfeld JF, Kristiansen VB, van Hall G, Holst JJ, Madsbad S. Postprandial Nutrient Handling and Gastrointestinal Hormone Secretion After Roux-en-Y Gastric Bypass vs Sleeve Gastrectomy. Gastroenterology. 2019 May;156(6):1627-1641.e1. doi: 10.1053/j.gastro.2019.01.262. Epub 2019 Feb 8.

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 1, 2016
• Primary Completion (ACTUAL): June 1, 2017
• Study Completion (ACTUAL): June 1, 2017

Study Registration Dates

• First Submitted: February 6, 2017
• First Submitted That Met QC Criteria: February 6, 2017
• First Posted (ESTIMATE): February 8, 2017

Study Record Updates

• Last Update Posted (ACTUAL): November 30, 2020
• Last Update Submitted That Met QC Criteria: November 25, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Keywords: Gastric bypass; Gastric sleeve
• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity; Obesity, Morbid
• Other Study ID Numbers: MS-SGRYGB-15

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No