Protocol for Alpha MSH Infusion Study in Patients With Type 2 Diabetes
Alpha-melanocyte stimulatory hormone (α-MSH) is a melanocyte-stimulating hormone produced by the hypothalamus and released from the pituitary gland. It acts as an agonist to the melanocortin 5 receptor (MC5R) in human skeletal muscle, playing a role in glucose uptake and disposal. This study aims to investigate whether α-MSH can enhance glucose tolerance in patients with Type 2 Diabetes Mellitus (T2DM).
- EligibilityCriteria: Inclusion Criteria:  People with T2DM treated with oral or injectable medications which have been stable for 3 months, but not insulin therapy for type 2 diabetes. Stable body weight and HbA1c for at least 3 months The participant is capable of giving written informed consent The participant is able to read, comprehend and record information written in English  Exclusion Criteria:  Previous or current psychiatric diagnosis listed in DSM-V Axis 1. Significant current or past medical or psychiatric history that, in the opinion of the investigators, contraindicates their participation. History of type 1 diabetes mellitus. History of endocrine disorder. History of ischaemic heart disease, hypertension (current BP > 160/95 mmHg), heart failure, cardiac arrhythmia, peripheral vascular or cerebrovascular disease. 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. 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, contraindicates their participation. Use of current regular prescription or over-the-counter medications that in the opinion of the Investigators may affect participant safety or outcome measures. 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. Current pregnancy or breast-feeding in female participants (the investigators would advise using contraception for the duration of the study). Pulse rate <40 or >100 beats per minute OR systolic blood pressure >160 and <100 and a diastolic blood pressure >95 and <50 in the semi-supine position. 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). Exposure to more than 3 new investigational medicinal products within 12 months prior to the screening. Participants who have donated, or intend to donate, blood within three months before the screening visit or following study visit completion. - HealthyVolunteers: No - Gender: All - MinimumAge: 21 Years - MaximumAge: 50 Years - StdAgeList: Adult