protocol for alpha msh infusion study in patients with type 2 diabetes

Conditions: Type 2 Diabetes Mellitus

Summary: 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).

pre-clinical studies in mice have shown improved glucose clearance with α-msh infusion, particularly in skeletal muscle. research has demonstrated that α-msh improves glucose tolerance in healthy humans by promoting glucose uptake in skeletal muscle cells. therefore this study seeks to answer the question of whether alpha-msh improves glucose tolerance in patients with t2dm. this will be addressed through measuring the impact of α-msh infusion in patients with t2dm. the research involves a double-blinded, randomized, placebo-controlled crossover study.

Eligibility criteria:
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 \ 100 beats per minute or systolic blood pressure \>160 and \ 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.

Keywords: type 2 diabetes, alpha-melanocyte stimulatory hormone (ɑ-msh), ogtt