Physiological Responses to Laparoscopic Sleeve Gastrectomy: Focusing on Ghrelin

Bariatric Surgery Clinical Trial

Official title:

Physiological Responses to Laparoscopic Sleeve Gastrectomy: Focusing on Ghrelin

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04055025
• Other study ID #: H-19010763
• Status: Completed
• Phase: N/A
• Start date: February 28, 2020
• Est. completion date: May 20, 2022

Study information

• Verified date: February 2024
• Source: Hvidovre University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: May 20, 2022
• Est. primary completion date: May 12, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Bariatric Surgery

Intervention

Other:
• Placebo
Four-hour liquid solid meal tests and a subsequent ad libitum meal during saline infusion.
• Ghrelin
Four-hour liquid solid meal tests and a subsequent ad libitum meal during acyl-ghrelin infusion.

Locations

Country	Name	City	State
Denmark	Department of Endocrinology, Hvidovre University Hospital	Copenhagen	Hvidovre

Sponsors (1)

Lead Sponsor	Collaborator
Hvidovre University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ad libitum	Ad libitum food intake (gram) with and without infusion of ghrelin at 3 months after LSG surgery	240 minutes
Secondary	Ad libitum	Ad libitum food intake (gram) with and without ghrelin infusion before surgery.	240 minutes
Secondary	Ghrelin	Plasma concentration profile of ghrelin (AUC) before and after LSG.	240 minutes