Investigating the impact of glucagon timing and protein replacement on metabolism

Not Applicable

Active, not recruiting

• Conditions: Overweight/obesity; Nutritional, Metabolic, Endocrine

• Registration Number: ISRCTN14693165
• Lead Sponsor: Imperial College London

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-02-01
• Last Update Posted: 12 February 2024
• Study Completion: 2025-07-01

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

1. Aged 18-65 years
2. Male or female
3. Glycated haemoglobin (HbA1C) <48 mmol/mol
4. BMI 25-45 kg/m², stable weight for >3 months

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified