Glucose clearance from the blood Nutritional, Metabolic, Endocrine
Conditions
Interventions
Current intervention as of 19/11/2021:
For this prospective double-blinded (both the researchers and study participants are unaware of the intervention) randomised controlled trial (RCT), the research
Sponsors
Imperial College London
Eligibility
Sex/Gender
All
Age
18 Years to 50 Years
Inclusion criteria
Inclusion criteria: Current participant inclusion criteria as of 19/11/2021: Work Package 1 and 2: 1. 18-50 years old 2. Normal fasting glucose ( = 18 < 30 kg/m² 5. The participant is capable of giving written informed consent 6. The participant is able to read, comprehend and record information written in English
Exclusion criteria
Exclusion criteria: 1. Previous or current psychiatric diagnosis listed in DSM-V Axis 1 2. Significant current or past medical or psychiatric history that, in the opinion of the investigators, contraindicates their participation 3. History of type 1 or type 2 diabetes mellitus 4. History of endocrine disorder 5. History of ischaemic heart disease, hypertension, heart failure, cardiac arrhythmia, peripheral vascular or cerebrovascular disease. 6. History or presence of significant respiratory, gastrointestinal, hepatic, oncological, neurological or renal disease or other condition that in the opinion of the Investigators may affect participant safety or outcome measures 7. Unwillingness or inability to follow the procedures outlined in the protocol 8. History of sensitivity to any of the peptides, or components thereof, or a history of drug or other allergy that, in the opinion of the investigators, contraindicates their participation 9. Use of current regular prescription or over-the-counter medications that in the opinion of the Investigators may affect participant safety or outcome measures 10. Clinically significant abnormalities in screening electrocardiogram (ECG) or blood tests abnormalities which in the opinion of the study physician, is clinically significant and represents a safety risk 11. Current pregnancy or breast-feeding in female participants (the Investigators would advise on using contraception for the duration of the visits) 12. Pulse rate 100 beats per minute OR systolic blood pressure > 160 and 95 and < 50 in the semi-supine position 13. The participant has participated in a clinical trial and has received an investigational product within the following time period prior to the first experimental visit in the current study: 90 days, 5 half-lives or twice the duration of the biological effect of the investigational product (whichever is longer) 14. Exposure to more than 3 new investigational medicinal products within 12 months prior to the screening 15. Participants who have donated, or intend to donate, blood within three months before the screening visit or following study visit completion
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Current primary outcome measure as of 19/11/2021: Work Package 1: 1. Difference in the total or incremental area under the curve of glucose concentration at an OGTT during saline vs. alpha-MSH infusion at 0-180 minutes 2. Difference in the total or incremental area under the curve of insulin concentration at an OGTT during saline vs. alpha-MSH infusion at 0-180 minutes 3. Difference in the glucose infusion rate at the euglycaemic hyperinsulinaemic clamp during saline vs. alpha-MSH infusion Work Package 2: 1. Difference in the total or incremental area under the curve of glucose concentration at an OGTT during saline vs. 1500 ng/kg/hr alpha-MSH infusion at 0-180 minutes 2. Difference in the total or incremental area under the curve of insulin concentration at an OGTT during saline vs. 1500 ng/kg/hr alpha-MSH infusion at 0-180 minutes Work Package 3: 1. Difference in the total or incremental area under the curve of glucose concentration at an OGTT during saline vs. 1500 ng/kg/hr alpha-MSH infusion at 0-180 minutes Previous primary outcome measure: 1. Area under the curve of glucose concentration measured using blood tests at an OGTT during saline vs. alpha-MSH infusion visits at 0-180 minutes 2. Glucose infusion rate measured using blood tests at the euglycaemic hyperinsulinaemic clamp during saline vs. alpha-MSH infusion visits at 0-240 minutes | — |
Secondary
| Measure | Time frame |
|---|---|
| Current secondary outcome measures as of 19/11/2021: Work Package 1: 1. Difference in the total or incremental area under the curve of the concentration of the following metabolites during OGTT and clamp with saline or alpha-MSH infusion at 0-180 minutes: 1.1. Insulin measured using blood tests 1.2. C-peptide measured using blood tests 1.3. Glucagon measured using blood tests 1.4. GLP-1 measured using blood tests 1.5. a-MSH measured using blood tests 2. Adverse events (including flushing) as reported by the participant using visual analogue scales at -30 to 180 minutes Work Package 2: 1. Difference in the total or incremental area under the curve of the concentration of the following metabolites during OGTT and clamp with saline or 1500 ng/kg/hr alpha-MSH infusion at 0-180 minutes: 1.1. Insulin measured using blood tests 1.2. C-peptide measured using blood tests 1.3. Glucagon measured using blood tests 1.4. GLP-1 measured using blood tests 1.5. a-MSH measured using blood tests 2. Adverse events (including flushing) as reported by the participant using visual analogue scales at -30 to 180 minutes Work Package 3: 1. Difference in the total or incremental area under the curve of the concentration of the following metabolites during OGTT and clamp with saline or 1500 ng/kg/hr alpha-MSH infusion at 0-180 minutes: 1.1. Insulin measured using blood tests 1.2. C-peptide measured using blood tests 1.3. Glucagon measured using blood tests 1.4. GLP-1 measured using blood tests 1.5. a-MSH measured using blood tests 2. Adverse events (including flushing) as reported by the participant using visual analogue scales at -30 to 180 minutes Previous secondary outcome measures: 1. Area under the curve for the following metabolites during OGTT and clamp during saline or alpha-MSH infusion visits at 0-180 minutes: 1.1. Insulin measured using blood tests 1.2. C-peptide measured using blood tests 1.3. Glucagon measured using blood tests 1.4. GLP-1 measured using blood tests 1.5. a-MSH mea | — |
Countries
England, Northern Ireland, United Kingdom
Contacts
Public ContactBrett Johnson
Outcome results
None listed