Physiological Responses to Laparoscopic Sleeve Gastrectomy: Focusing on Ghrelin

NCT ID: NCT04055025

Last Updated: 2024-02-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-02-28
• Study Completion Date: 2022-05-20

Brief Summary

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.

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.

Conditions

Bariatric Surgery

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Sleeve gastrectomy operated patients

Six test days in a randomized, patient-blinded, cross-over design

Group Type: OTHER

Placebo

Intervention Type: OTHER

Four-hour liquid solid meal tests and a subsequent ad libitum meal during saline infusion.

Ghrelin

Intervention Type: OTHER

Four-hour liquid solid meal tests and a subsequent ad libitum meal during acyl-ghrelin infusion.

Interventions

Placebo

Four-hour liquid solid meal tests and a subsequent ad libitum meal during saline infusion.

Intervention Type: OTHER

Ghrelin

Four-hour liquid solid meal tests and a subsequent ad libitum meal during acyl-ghrelin infusion.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Signed written informed consent
• Fasting plasma glucose <6.1 mmol/l

Exclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Hvidovre University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Nora Elisabeth Hedbäck

Medical Doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Nora Hedbäck, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Endocrinology, Hvidovre University Hospital, Denmark

Locations

Department of Endocrinology, Hvidovre University Hospital

Copenhagen, Hvidovre, Denmark

Countries

Denmark

Other Identifiers

H-19010763

Identifier Type: -

Identifier Source: org_study_id