OverweightEarly Phase 1NCT04690270
Sumatriptan and Glucose
A Early Phase 1 study testing Sumatriptan 100 mg in people with Overweight, run by Cambridge University Hospitals NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Overweight
- What is being tested?
- Sumatriptan 100 mg
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 4 Jan 2021to 25 Jun 2021
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Being able to provide a written informed consent
- Age between 18 and 65 years
- Body Mass Index (BMI) ≥25 kg/m2 and <30 kg/m2 for non-Asian individuals and BMI≥23 kg/m2 and <25 kg/m2 for Asian individuals according to the BMI classification by the World Health Organization (WHO)
- HbA1C<48 mmol/mol at screening
- Subject must not use any regular prescribed medications (this excludes simple analgesia used as needed)
- Subject must not use any over the counter supplements targeting metabolism
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- Subject must not have any acute or chronic disease which in the opinion of the investigator may affect the study outcome
- Subject must not be a current smoker
- No history of substance abuse or excess alcohol consumption (>14 units/week)
- Women of childbearing age must have a negative pregnancy test at screening and must not be breastfeeding
- Women of childbearing age who are sexually active with a male partner must use highly effective contraceptive methods
Who cannot join
- Use of any regular medications
- Use of illicit drugs
- Use of any over the counter supplements affecting metabolism
- Diagnosis of any acute / chronic disease
- Current smoking or excess alcohol consumption (>14 units/week)
- Current pregnancy or lactation
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- Abnormal findings on physical exam or routine blood tests at screening (full blood count, urea and electrolytes, HbA1C, liver function tests)
- Concurrent participation in another trial with an investigational product
- History of anaphylaxis
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Rajna Golubic
Cambridge, Cambridgeshire, CB2 0QQ
Rajna Golubic, MD, PhD, 01223748471, rg380@medschl.cam.ac.uk
Jane Kennet, 01223748471, jk605@cam.ac.uk
About this study
Official title: Effects of Serotonin Receptor Agonism on Blood Glucose Lowering: Proof of Concept in Humans
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.
- Conditions
- Overweight
- Being tested
- Sumatriptan 100 mg
- Keywords
- type 1 diabetes, type 2 diabetes, glucose homeostasis, insulin secretion, insulin sensitivity, serotonin agonism
- Medical subject headings
- Overweight, Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sumatriptan 100 mgDrug
Also called Example of a brand name for sumatriptan: Migratan
Single dose Sumatriptan 100 mg
| Study group | Role | What they receive |
|---|---|---|
| Sumatriptan 100 mg | Experimental | Given the cross-over design all participants will receive both sumatriptan (100 mg, single dose) and placebo in a random order. Receives: Drug: Sumatriptan 100 mg |
| Placebo | Placebo comparator | Given the cross-over design all participants will receive both sumatriptan (100 mg, single dose) and placebo in a random order. Receives: Drug: Sumatriptan 100 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Insulin sensitivity
Change in M-value from the hyperinsulinaemic euglycaemic clamp from visit 2 to visit 3 between sumatriptan and placebo
Measured: 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
Measured: 1 to 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2020
- Study start4 Jan 2021 (estimated)
- Primary completion25 Jun 2021 (estimated)
- Study completion25 Jun 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OverweightStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cambridge University Hospitals NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Rajna Golubic, Cambridge University Hospitals NHS Foundation Trust
- Investigators
- Mark Evans, Study chair, Institute of Metabolic Science, Hills Road, CB2 0QQ, Cambridge, UK
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04690270
- Sponsor's protocol ID
- A095470
- Other IDs
- 277675
- Status last verified
- Dec 2020
- First submitted
- 27 Dec 2020
- Last updated
- 30 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Serotonin Receptor Agonism on Blood Glucose Lowering: Proof of Concept in Humans
- ClinicalTrials.gov ID
- NCT04690270
- Acronym / sponsor ID
- A095470
- Conditions
- Overweight
- Keywords
- type 1 diabetes, type 2 diabetes, glucose homeostasis, insulin secretion, insulin sensitivity, serotonin agonism
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Cambridge University Hospitals NHS Foundation TrustUniversity, hospital or other
- Study start
- 4 Jan 2021 (estimated)
- Primary completion
- 25 Jun 2021 (estimated)
- Study completion
- 25 Jun 2021 (estimated)
- First posted
- 30 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sumatriptan 100 mg | Experimental | Drug: Sumatriptan 100 mgGiven the cross-over design all participants will receive both sumatriptan (100 mg, single dose) and placebo in a random order. |
| Placebo | Placebo comparator | Drug: Sumatriptan 100 mgGiven the cross-over design all participants will receive both sumatriptan (100 mg, single dose) and placebo in a random order. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Being able to provide a written informed consent
- Age between 18 and 65 years
- Body Mass Index (BMI) ≥25 kg/m2 and <30 kg/m2 for non-Asian individuals and BMI≥23 kg/m2 and <25 kg/m2 for Asian individuals according to the BMI classification by the World Health Organization (WHO)
- HbA1C<48 mmol/mol at screening
- Subject must not use any regular prescribed medications (this excludes simple analgesia used as needed)
Key exclusion criteria (9 listed)
- Use of any regular medications
- Use of illicit drugs
- Use of any over the counter supplements affecting metabolism
- Diagnosis of any acute / chronic disease
- Current smoking or excess alcohol consumption (>14 units/week)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sumatriptan 100 mgAlso: Example of a brand name for sumatriptan: MigratanSingle dose Sumatriptan 100 mg | Drug | Placebo, Sumatriptan 100 mg |
Primary outcome
Insulin sensitivity
Time frame: 1 to 4 weeks
Change in M-value from the hyperinsulinaemic euglycaemic clamp from visit 2 to visit 3 between sumatriptan and placebo
Insulin secretion
Time frame: 1 to 4 weeks
Change in first phase insulin response from the intravenous glucose tolerance test from visit 2 to visit 3 between sumatriptan and placebo
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Dec 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mark Evans study chair
Institute of Metabolic Science, Hills Road, CB2 0QQ, Cambridge, UK
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Sumatriptan 100 mg in people with Overweight, run by Cambridge University Hospitals NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rajna Golubic, MD, PhD (01223748471, rg380@medschl.cam.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Insulin sensitivity (time frame: 1 to 4 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Dec 2020.