Physiological Responses to Laparoscopic Sleeve Gastrectomy: Focusing on Ghrelin

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04055025

Enrollment

Registered

2019-08-13

Start date

2020-02-28

Completion date

2022-05-20

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bariatric Surgery

Keywords

Ghrelin, Sleeve gastrectomy, Laparoscopic sleeve gastrectomy

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.

Interventions

OTHERPlacebo

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

OTHERGhrelin

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

BASIC_SCIENCE

Masking

NONE

Masking description

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

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
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.

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026