NCT04055025

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 7, 2019

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 13, 2019

Completed
7 months until next milestone

Study Start

First participant enrolled

February 28, 2020

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 12, 2022

Completed
8 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 20, 2022

Completed
Last Updated

February 28, 2024

Status Verified

February 1, 2024

Enrollment Period

2.2 years

First QC Date

August 7, 2019

Last Update Submit

February 27, 2024

Conditions

Bariatric Surgery

Keywords

GhrelinSleeve gastrectomyLaparoscopic sleeve gastrectomy

Outcome Measures

Primary Outcomes (1)

  • Ad libitum

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

    240 minutes

Secondary Outcomes (2)

  • Ad libitum

    240 minutes

  • Ghrelin

    240 minutes

Study Arms (1)

Sleeve gastrectomy operated patients

OTHER

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

Other: PlaceboOther: Ghrelin

Interventions

PlaceboOTHER

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

Sleeve gastrectomy operated patients
GhrelinOTHER

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

Sleeve gastrectomy operated patients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Endocrinology, Hvidovre University Hospital

Copenhagen, Hvidovre, 2650, Denmark

Location

MeSH Terms

Interventions

Ghrelin

Intervention Hierarchy (Ancestors)

Peptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and Proteins

Study Officials

  • Nora Hedbäck, MD

    Department of Endocrinology, Hvidovre University Hospital, Denmark

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Masking Details
The study visits will be performed in randomized orders and participants will not now if they will receive ghrelin or saline.
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical Doctor

Study Record Dates

First Submitted

August 7, 2019

First Posted

August 13, 2019

Study Start

February 28, 2020

Primary Completion

May 12, 2022

Study Completion

May 20, 2022

Last Updated

February 28, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will not share

Locations

DK(1)