Bariatric Surgery Candidate Clinical Trial
Official title:
The Importance of Ghrelin for Glucose Metabolism After Sleeve Gastrectomy
Verified date | October 2023 |
Source | Hvidovre University Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 22 |
Est. completion date | June 26, 2023 |
Est. primary completion date | June 26, 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Sleeve gastrectomy-operated > 12 months prior to inclusion - 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: - Pregnancy or breastfeeding. - Haemoglobin < 6,5 mM. |
Country | Name | City | State |
---|---|---|---|
Denmark | Hvidovre Universitets Hospital | Hvidovre |
Lead Sponsor | Collaborator |
---|---|
Hvidovre University Hospital | Institute of Biomedical Sciences, SUND, University of Copenhagen |
Denmark,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | The difference in first phase insulin response (FPIR) between the two study days with and without ghrelin in fusion in the SG operated group | Estimation of beta-cell function, calculated from insulin secretion rate using c-peptid and deconvolution from 0-10 min. | 0-10 minutes (IVGTT) | |
Secondary | The difference in Insulin sensitivity (M-value) between the two study days with and without ghrelin in fusion in the SG operated group | When a steady state is reached at the end of the clamp, the glucose infusion rate represents insulin-mediated glucose uptake by the body. | 160-180 minutes (the end of the clamp) |
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