Overweight/obesity Nutritional, Metabolic, Endocrine
Conditions
Interventions
Following an initial screening visit, participants will attend the NIHR Imperial Clinical Research Facility for a 4-day inpatient stay, where they will undergo a 72-hr intravenous infusion. Participan
Sponsors
Imperial College London
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Aged 18-65 years 2. Male or female 3. Glycated haemoglobin (HbA1C) 3 months
Exclusion criteria
Exclusion criteria: 1. Diabetes mellitus of any type 2. Previous bariatric surgery 3. Current pregnancy or breastfeeding 4. History of having donated blood in the preceding 3 months 5. Alcohol intake >14 units/week 6. History of autoimmune liver disease or viral hepatitis 7. Pancreatic diseases 8. Severe gastrointestinal diseases 9. Drugs that affect hepatic steatosis 10. Subjects who have used prescription drugs within 4 weeks of first dosing, except antihypertensive treatments provided that the doses have not been altered within 4 weeks prior to entering the study 11. Subjects using Hypolipidaemic treatments 12. Subjects who have a history of relevant and severe atopy e.g. asthma, angioedema requiring emergency treatment, severe hayfever requiring regular treatment (i.e. taking antihistamines and/or glucocorticoids more regularly than 3 times a week), severe eczema requiring regular treatment (i.e. taking antihistamines and/or glucocorticoids more regularly than 3 times a week) 13. Subjects who have a history of relevant drug hypersensitivity 14. Subjects who have a history of alcohol abuse or alcohol dependence according to DSM-IV criteria within the last 2 years 15. Subjects who have a history of drug or substance abuse according to DSM-IV criteria within the last 2 years 16. Subjects who have a history of clinically significant migraine as judged by the Investigator. Subjects can be included if they have not had a migraine for the last 3 years 17. Subjects who have a significant infection or known inflammatory process on screening 18. Subjects who have acute gastrointestinal symptoms at the time of screening or admission (e.g. nausea, vomiting, diarrhoea, heartburn) 19. Subjects who have an acute infection such as influenza at the time of screening or admission 20. Subjects who have donated blood within 3 months prior to screening 21. Subjects who have donated plasma within the 7 days prior to screening 22. Subjects who have donated platelets within the 6 weeks prior to screening 23. Subjects who have used any investigational drug in any clinical trial within 3 months of their first admission date 24. Subjects who have received the last dose of investigational drug greater than 3 months ago but who are on extended follow-up
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Circulating amino acids and lipids will be measured using mass spectrometry prior to infusion commencement, during the daytime and nighttime. 2. Energy expenditure will be measured using indirect calorimetry at baseline and at steady state during the infusion | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Appetite will be measured using visual analogue scales before and after each meal. 2. Glucose will be monitored using continuous glucose monitoring, over the 72 hour infusion period. | — |
Countries
England, United Kingdom
Contacts
Public ContactTricia Tan
Outcome results
None listed