Does an infusion of alpha-melanocyte stimulating hormone reduce blood sugar after a sugary drink in healthy people and those with type 1 diabetes mellitus?

Authors
Category Primary study
Registry of TrialsISRCTN registry
Year 2020
INTERVENTION: For this prospective double‐blinded (both the researchers and study participants are unaware of the intervention) randomised control trial (RCT) the researchers plan to recruit 15 healthy volunteers from the general public. The participants will be healthy male and female volunteers (we aim to recruit 8 males and 7 females) above the age of 18 with no major medical conditions. Prior to being accepted into the study, participants will first be screened by a member of the research team to ensure they meet the inclusion and exclusion criteria. At this screening visit, participants will be informed about the study and have the opportunity to ask questions. They will be given a detailed participant information sheet which they may keep to review. Once the participant has been given a minimum of 24 hours to consider their entry into the study, informed consent in person will be obtained. Every participant will then attend 4 separate morning visits at Hammersmith Hospital after an overnight fast (fasted since 10 pm the night before). Each visit will last approximately 4 hours and take place at a minimum of 1‐week intervals. At each of these visits the participants will be randomised (assigned at random by a computer programme) to infusions of one of three doses of alpha‐MSH or placebo (normal saline ‐ 0.9% sodium chloride (salt) solution). These infusions will last for 150 minutes and will be delivered through an intravenous cannula placed in the arm. A second cannula will be inserted into the other arm to enable extraction of blood samples. Thirty minutes after each infusion begins, participants will be asked to consume a sugary drink which will raise their blood sugar levels. Throughout the infusion, blood will be drawn and CONDITION: Glucose clearance from the blood ; Nutritional, Metabolic, Endocrine PRIMARY OUTCOME: ; 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 OUTCOME: ; 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 measured using blood tests; 2. Adverse events (including flushing) as reported by the participant using visual analogue scales at ‐30 to 180 minutes; INCLUSION CRITERIA: 1. 18‐50 years old 2. Normal fasting glucose (< 5.6 mmol/l) 3. Stable body weight for at least 3 months 4. BMI > = 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
Epistemonikos ID: 5a7cf5d24f5d240d93d6104bf5e66de4fb8b4ce0
First added on: Aug 24, 2024