Clinical trial NCT06293664: Protocol for Alpha MSH Infusion Study in Patients With Type 2 Diabetes
Official title: Randomized Cross-over Designed Study of the Physiological Impact of Alpha MSH on Glycemic Response to an Oral Glucose Tolerance Test in Patients With Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Type 2 Diabetes Mellitus
Keywords: Type 2 Diabetes, Alpha-melanocyte stimulatory hormone (ɑ-MSH), OGTT
Lead sponsor: Dasman Diabetes Institute
Sponsor class: OTHER
First posted: 2024-03-05
Enrollment: 13
Sex: ALL
Minimum age (years): 21
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: The research involves a double-blinded, randomized, placebo-controlled crossover study to assess the therapeutic potential of α-MSH infusion in T2DM patients.
Primary purpose: SCREENING

Brief 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).

Detailed description: 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 \<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.

Primary outcomes:
measure: Difference in the total or incremental area under the curve of glucose and insulin concentration at an OGTT during saline vs. α-MSH infusion
timeFrame: 12 months
Secondary outcomes:
measure: Difference in the total or incremental area under the curve of the concentration of metabolites (C-peptide, Glucagon, Gut hormones, α-MSH) during OGTT with saline or α-MSH infusion.
timeFrame: 12 months
Other outcomes:
measure: Difference in energy intake measured by an ad libitum meal test at the saline vs. α-MSH infusion
timeFrame: 12 months
measure: Adverse events (including flushing)
timeFrame: 12 months
Locations:
city: Kuwait City
country: Kuwait
facility: Dasman Diabetes Institute
Study officials:
References: