Physiological Responses to Laparoscopic Sleeve Gastrectomy: Focusing on Ghrelin

Our hypothesis is that decreased concentration of ghrelin after LSG is important for the decreased appetite and food intake postoperatively. We therefore expect infusion of ghrelin will increase an ad libitum food intake after LSG. We also expect that a decreased postprandial concentration of ghrelin after LSG play a role for increased insulin secretion and decreased postprandial plasma glucose concentrations after surgery.

Study Overview

• Status: Completed
• Conditions: Bariatric Surgery
• Intervention / Treatment: Other: Placebo; Other: Ghrelin

Detailed Description

Laparoscopic Roux-en-Y gastric bypass (LRYGB) and laparoscopic sleeve gastrectomy (LSG) are to bariatric procedure. After both procedures, a changed secretion of hormones from the gastrointestinal tract is believed to affect appetite and glucose metabolism. Studies have shown that after LRYGB, there is a significant increased secretion of GLP-1 and PYY. In contrast, a decreased secretion of ghrelin is a characteristic finding after LSG opposite post-LRYGB, where secretion of ghrelin is reported to be increased, decreased or unchanged. Ghrelin is primarily secreted from the gastric mucosa in the fasting state and decreases in response to food intake. Ghrelin stimulates food intake through appetite-regulating centers in the hypothalamus. Administration of exogenous ghrelin has been reported to stimulate appetite. In addition, ghrelin has recently been suggested also to affect glucose metabolism by inhibition of glucose-stimulated insulin secretion. Therefore the markedly decreased secretion of ghrelin could be of particular important for the decreased appetite and improved glucose tolerance seen after LSG.

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Hvidovre
    • Copenhagen, Hvidovre, Denmark, 2650
      • Department of Endocrinology, Hvidovre University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• The Danish national inclusion criteria for bariatric surgery
• Signed written informed consent
• Fasting plasma glucose <6.1 mmol/l

Exclusion Criteria:

• Pregnancy or breastfeeding.
• Hemoglobin <6.5 mM
• Newly emerged serious disease

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Sleeve gastrectomy operated patients; Six test days in a randomized, patient-blinded, cross-over design	Other: Placebo; Four-hour liquid solid meal tests and a subsequent ad libitum meal during saline infusion.; Other: Ghrelin; Four-hour liquid solid meal tests and a subsequent ad libitum meal during acyl-ghrelin infusion.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ad libitum	Ad libitum food intake (gram) with and without infusion of ghrelin at 3 months after LSG surgery	240 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ad libitum	Ad libitum food intake (gram) with and without ghrelin infusion before surgery.	240 minutes
Ghrelin	Plasma concentration profile of ghrelin (AUC) before and after LSG.	240 minutes

Collaborators and Investigators

• Sponsor: Hvidovre University Hospital
• Investigators: Principal Investigator: Nora Hedbäck, MD, Department of Endocrinology, Hvidovre University Hospital, Denmark

Study record dates

Study Major Dates

• Study Start (Actual): February 28, 2020
• Primary Completion (Actual): May 12, 2022
• Study Completion (Actual): May 20, 2022

Study Registration Dates

• First Submitted: August 7, 2019
• First Submitted That Met QC Criteria: August 12, 2019
• First Posted (Actual): August 13, 2019

Study Record Updates

• Last Update Posted (Actual): February 28, 2024
• Last Update Submitted That Met QC Criteria: February 27, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Sleeve gastrectomy; Ghrelin; Laparoscopic sleeve gastrectomy
• Other Study ID Numbers: H-19010763

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