None listed
Conditions
Brief summary
In healthy adults, alpha-MSH increased glucose clearance and spared insulin during an oral glucose tolerance test, while having no effect during a fasting infusion. We now aim to understand whether alpha-MSH increases glucose clearance during an oral glucose tolerance test in people with type 1 diabetes. If glucose clearance is improved, a new adjunctive treatment for type 1 diabetes could be developed to improve glucose control and lower insulin doses. Participants will receive two treatments; alpha-MSH and placebo, through an intravenous infusion lasting 3.5 hours at two separate visits. Those using an insulin pump will set it to a temporary basal rate immediately prior to the infusion. The first 30 minutes of the infusion will be fasted to assess the effects of alpha-MSH on basal glucose. 30 minutes after commencing the infusion, those that use bolus insulin will administer a dose of their usual bolus insulin that is half the usual amount that they would give to cover the glucose load. Participants will then drink 75g of glucose over 5 minutes. Blood samples will be collected at -30, 0, 15, 30, 60, 90, 120 and 180 minutes relative to consumption of the glucose drink and analysed to determine whether alpha-MSH increases glucose clearance. At the end of the 3.5 hour infusion, participants will be offered a meal and monitored.
Interventions
10ug/ml alpha-MSH in saline administered via intravenous infusion at 1500ng/kg/hr, commencing at time -30 minutes and continued until time 180 minutes. At time 0 minutes, participants will consume a drink containing 75g glucose within 5 minutes. The intravenous infusion and glucose challenge will be supervised by a research nurse. The wash out period between the intervention and comparator treatments will be at least 2 days and no longer than 6 weeks. Participants will be asked to administer hal
10ug/ml alpha-MSH in saline administered via intravenous infusion at 1500ng/kg/hr, commencing at time -30 minutes and continued until time 180 minutes. At time 0 minutes, participants will consume a drink containing 75g glucose within 5 minutes. The intravenous infusion and glucose challenge will be supervised by a research nurse. The wash out period between the intervention and comparator treatments will be at least 2 days and no longer than 6 weeks. Participants will be asked to administer half of the usual insulin dose they would normally take to cover the glucose load immediately prior to consuming the glucose drink (time 0 minutes), or if they use an insulin pump, asked to set the pump to a temporary basal rate immediately prior to the infusion (-30 minutes). The study doctor will consult with each participant to formulate a plan for insulin dosing before and during the oral glucose tolerance test.
Sponsors
Monash University
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to 50 Years
Healthy volunteers
No
Inclusion criteria
Type 1 diabetes with a confirmed diagnosis of at least 3 years' duration and a plasma or serum c-peptide of less than 0.1 nM. BMI equal or greater than 18 and less than 30kg/m2, with a stable body weight for at least three months prior to enrolment. Be able to read and understand the written information about the study and provide written consent to participate in it.
Exclusion criteria
Significant current or past medical or psychiatric history that, in the opinion of the investigators, would pose unacceptable risk Unwillingness or inability to follow the procedures outlined in the protocol 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, would pose unacceptable risk Clinically significant abnormalities in screening electrocardiogram (ECG) or blood tests which, in the opinion of the study physician, would pose unacceptable risk Current pregnancy or breast-feeding in female participants or, if sexually active and of childbearing potential, unwilling to use effective contraception for the duration of the study The participant has received an investigational product within the preceding 90 days, 5 half-lives or twice the duration of its biological effect (whichever is longer) Exposure to more than 3 new investigational medicinal products within 12 months prior to the screening Poor venous access Unable or unwilling to wear a continuous glucose monitoring sensor for the duration of the study
Outcome results
None listed