Sumatriptan and Glucose

NCT04690270 | Unknown Early Phase 1

• 2 other identifiers: A095470277675
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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 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

Keywords

type 1 diabetes; type 2 diabetes; glucose homeostasis; insulin secretion; insulin sensitivity; serotonin agonism

Outcome Measures

Primary Outcomes (2)

• Insulin sensitivity

  Change in M-value from the hyperinsulinaemic euglycaemic clamp from visit 2 to visit 3 between sumatriptan and placebo

  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

  1 to 4 weeks

Study Arms (2)

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.

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.

Drug: Sumatriptan 100 mg

Interventions

Sumatriptan 100 mg DRUG

Single dose Sumatriptan 100 mg

Also known as: Example of a brand name for sumatriptan: Migratan

Placebo; Sumatriptan 100 mg

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Cambridge University Hospitals NHS Foundation Trust: lead

Study Sites (1)

Rajna Golubic

Cambridge, Cambridgeshire, CB2 0QQ, United Kingdom

Location

MeSH Terms

Conditions

Overweight; Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2; Insulin Resistance

Interventions

Sumatriptan

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases; Hyperinsulinism

Intervention Hierarchy (Ancestors)

Sulfonamides; Amides; Organic Chemicals; Sulfones; Sulfur Compounds; Tryptamines; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Mark Evans

  Institute of Metabolic Science, Hills Road, CB2 0QQ, Cambridge, UK

  STUDY CHAIR

Central Study Contacts

Rajna Golubic, MD, PhD

CONTACT

01223748471; rg380@medschl.cam.ac.uk

Jane Kennet, MD, FRCP

CONTACT

01223748471; jk605@cam.ac.uk

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: December 27, 2020
• First Posted: December 30, 2020
• Study Start: January 4, 2021
• Primary Completion: June 25, 2021
• Study Completion: June 25, 2021
• Last Updated: December 30, 2020

Record last verified: 2020-12

Locations

GB (1)