An Early Phase 1 interventional study of Sumatriptan 100 mg in Overweight, sponsored by Cambridge University Hospitals NHS Foundation Trust. Status unknown at 1 site in United Kingdom. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-12-30.
Sponsored by Cambridge University Hospitals NHS Foundation Trust · Early Phase 1, Interventional, and Treatment
The purpose of this study is to establish the proof of concept for a brain serotonin pathway controlling blood glucose control in humans. We will examine whether activation of serotonin receptors by a single dose of sumatriptan (a drug used for the treatment of migraine) can lead to short term changes in blood glucose homeostasis. Thus far, this has been shown only in animal models but no study in humans has directly investigated this research question.
Briefly, in this study we will give a single dose of sumatriptan (100 mg) to each participant in a small sample (10 to 12) of overweight or obese, otherwise healthy humans. It will take place in the Translational Research Facility which is embedded in the Cambridge University Hospitals NHS Foundation Trust. The research staff have extensive experience and expertise in the procedures which will be used. The study will involve a screening visit and 2 subsequent visits at which sumatriptan/placebo will be taken and the glucose metabolism will be assessed using a Botnia clamp (3h procedure involving insulin and glucose infusions given intravenously with frequent blood sampling to assess insulin secretion and sensitivity). There will be about 60 days between screening visit and the last visit. The entire study (including the recruitment and data analysis) is expected to complete in about 12 months.
If sumatriptan alters glucose control, this might support future testing in disease models i.e. people with type 1 diabetes (T1D) and/or type 2 diabetes (T2D). Ultimately, if successful, either sumatriptan could be repurposed and/or other drugs from this group (triptans) could be developed for diabetes.
3,670 studies on the registry are indexed under Overweight; 850 are open to participants now.
This study's planned enrollment of 12 is below the median of 73 across 3,175 interventional studies indexed under Overweight.
Browse Overweight studies →Cambridge University Hospitals NHS Foundation Trust is the lead sponsor of 167 studies on the registry; 37 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Given the cross-over design all participants will receive both sumatriptan (100 mg, single dose) and placebo in a random order.
Drug: Sumatriptan 100 mg
Given the cross-over design all participants will receive both sumatriptan (100 mg, single dose) and placebo in a random order.
Drug: Sumatriptan 100 mg
Single dose Sumatriptan 100 mg
Also known as: Example of a brand name for sumatriptan: Migratan
Insulin sensitivity
Change in M-value from the hyperinsulinaemic euglycaemic clamp from visit 2 to visit 3 between sumatriptan and placebo
Time frame: 1 to 4 weeks
Insulin secretion
Change in first phase insulin response from the intravenous glucose tolerance test from visit 2 to visit 3 between sumatriptan and placebo
Time frame: 1 to 4 weeks
This study is status unknown, as verified in Dec 2020. You cannot join it, but the record below documents what was studied.
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Cambridge University Hospitals NHS Foundation Trust