The Importance of Ghrelin for Glucose Metabolism After Sleeve Gastrectomy
NCT ID: NCT05189353
Last Updated: 2023-11-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
22 participants
INTERVENTIONAL
2022-01-14
2023-06-26
Brief Summary
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Detailed Description
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The mechanisms of improved glycaemic control after SG are not fully understood and differ from those of RYGB. Interestingly, there is demonstrated a markedly lower secretion of the orexigenic hormone ghrelin after SG compared with both RYGB and unoperated obese controls. Hence, the decreased level of ghrelin could be of major importance in relation to the improved glucose tolerance after SG.
Ghrelin is secreted from the gastric mucosa in the fasting state and decreases in response to food intake. Administration of exogenous ghrelin reduces insulin sensitivity and glucose tolerance in healthy humans and contributes to hyperglycaemia. In accordance, ghrelin receptor knockout in mice improves glucose sensitivity and enhances glucose-stimulated insulin secretion.
On this background the investigators hypothesize that the markedly reduced secretion of ghrelin after SG could therefore be of particularly importance for the improved glucose tolerance after this procedure.
This present study is complementary to an on-going study in SG operated subjects, where the role of ghrelin for appetite and insulin secretion during a mixed meal followed by an ad libitum meal are investigated. In the present study the effect of ghrelin on insulin secretion and insulin sensitivity is thoroughly investigated using methods eliminating the effect of other hormones on glucose metabolism.
Ghrelin will be infused in physiological doses aiming for plasma concentration after SG resembling the pre-operative plasma concentrations.
Specific aim is to evaluate the effect of ghrelin on both alpha and beta cell function as well as on liver and peripheral insulin sensitivity in individuals with SG using matched controls. The subjects will be investigated with both glucose and glycerol tracers, IVGTT and a hyperinsulinemic euglycaemic clamp.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
BASIC_SCIENCE
SINGLE
Study Groups
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Gastric sleeve operated
12 subjects with normal glucose tolerance (NGT) operated with SG minimum 12 month earlier
Ghrelin
Ghrelin infusion
Placebo
Saline infusion
Matched control group
12 weight-matched unoperated subjects with NGT
Ghrelin
Ghrelin infusion
Placebo
Saline infusion
Interventions
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Ghrelin
Ghrelin infusion
Placebo
Saline infusion
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* Haemoglobin \< 6,5 mM.
18 Years
ALL
Yes
Sponsors
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Institute of Biomedical Sciences, SUND, University of Copenhagen
UNKNOWN
Hvidovre University Hospital
OTHER
Responsible Party
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Marie-Louise Dichman
MD, Ph.d.-student
Locations
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Hvidovre Universitets Hospital
Hvidovre, , Denmark
Countries
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Other Identifiers
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H-21037442
Identifier Type: -
Identifier Source: org_study_id
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