Status:
UNKNOWN
Sumatriptan and Glucose
Lead Sponsor:
Cambridge University Hospitals NHS Foundation Trust
Conditions:
Overweight
Eligibility:
All Genders
18-65 years
Phase:
EARLY_PHASE1
Brief 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...
Eligibility Criteria
Inclusion
- 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
- 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
Exclusion
- 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
- 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
Key Trial Info
Start Date :
January 4 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 25 2021
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT04690270
Start Date
January 4 2021
End Date
June 25 2021
Last Update
December 30 2020
Active Locations (1)
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1
Rajna Golubic
Cambridge, Cambridgeshire, United Kingdom, CB2 0QQ