The Importance of Ghrelin for Glucose Metabolism After Sleeve Gastrectomy
1 other identifier
interventional
22
1 country
1
Brief Summary
The overall aim is to delineate the contribution of ghrelin to glucose tolerance after sleeve gastrectomy. The hypothesis is that decreased concentration of ghrelin after SG is of importance for improved insulin secretion and glucose tolerance seen after SG. The expectation is therefore that infusion of ghrelin will impair insulin secretion and glucose tolerance compared with a control day without ghrelin infusion.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jan 2022
1 active site
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
December 28, 2021
CompletedFirst Posted
Study publicly available on registry
January 12, 2022
CompletedStudy Start
First participant enrolled
January 14, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 26, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
June 26, 2023
CompletedNovember 1, 2023
October 1, 2023
1.4 years
December 28, 2021
October 31, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The difference in disposition index between the two study days with and without ghrelin in fusion in the SG operated group
The first phase insulin response will be related to the ambient insulin sensitivity by calculating the disposition index (FPIR x M-value).
0-180 minutes
Secondary Outcomes (2)
The difference in first phase insulin response (FPIR) between the two study days with and without ghrelin in fusion in the SG operated group
0-10 minutes (IVGTT)
The difference in Insulin sensitivity (M-value) between the two study days with and without ghrelin in fusion in the SG operated group
160-180 minutes (the end of the clamp)
Study Arms (2)
Gastric sleeve operated
EXPERIMENTAL12 subjects with normal glucose tolerance (NGT) operated with SG minimum 12 month earlier
Matched control group
PLACEBO COMPARATOR12 weight-matched unoperated subjects with NGT
Interventions
Eligibility Criteria
You may qualify if:
- Weight stable (+/- 3 kg during the last 3 months)
- Fasting glucose \< 7,0 mmol/l / HbA1c \< 48 mmol/mol pre- and postoperative
- Signed written informed consent
You may not qualify if:
- Pregnancy or breastfeeding.
- Haemoglobin \< 6,5 mM.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Hvidovre University Hospitallead
- University of Copenhagencollaborator
Study Sites (1)
Hvidovre Universitets Hospital
Hvidovre, 2650, Denmark
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Masking Details
- Single randomized clinical trial
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD, Ph.d.-student
Study Record Dates
First Submitted
December 28, 2021
First Posted
January 12, 2022
Study Start
January 14, 2022
Primary Completion
June 26, 2023
Study Completion
June 26, 2023
Last Updated
November 1, 2023
Record last verified: 2023-10