Physiological Responses to Laparoscopic Sleeve Gastrectomy: Focusing on Ghrelin

Sponsor

Hvidovre University Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT04055025

Collaborator

(none)

Enrollment

Location

Arm

32.1

Anticipated Duration (Months)

0.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Bariatric Surgery	Other: Placebo Other: Ghrelin	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

12 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Masking Description:

The study visits will be performed in randomized orders and participants will not now if they will receive ghrelin or saline.

Primary Purpose:

Basic Science

Official Title:

Physiological Responses to Laparoscopic Sleeve Gastrectomy: Focusing on Ghrelin

Actual Study Start Date :

Feb 28, 2020

Actual Primary Completion Date :

May 12, 2022

Anticipated Study Completion Date :

Nov 1, 2022

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Ad libitum [240 minutes]
Ad libitum food intake (gram) with and without infusion of ghrelin at 3 months after LSG surgery

Secondary Outcome Measures

Ad libitum [240 minutes]
Ad libitum food intake (gram) with and without ghrelin infusion before surgery.
Ghrelin [240 minutes]
Plasma concentration profile of ghrelin (AUC) before and after LSG.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Endocrinology, Hvidovre University Hospital	Copenhagen	Hvidovre	Denmark	2650

Sponsors and Collaborators

Hvidovre University Hospital

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Nora Elisabeth Hedbäck, Medical Doctor, Hvidovre University Hospital

ClinicalTrials.gov Identifier:

NCT04055025

Other Study ID Numbers:

H-19010763

First Posted:

Aug 13, 2019

Last Update Posted:

Aug 16, 2022

Last Verified:

Aug 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Nora Elisabeth Hedbäck, Medical Doctor, Hvidovre University Hospital

Ghrelin

Sleeve gastrectomy

Laparoscopic sleeve gastrectomy

Study Results

No Results Posted as of Aug 16, 2022