Protocol for Alpha MSH Infusion Study in Patients With Type 2 Diabetes (α-MSH & T2DM)

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

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).

Study Overview

• Status: Recruiting
• Conditions: Type 2 Diabetes Mellitus
• Intervention / Treatment: Other: α-MSH infusion; Other: Placebo solutions

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.

• Study Type: Interventional
• Enrollment (Estimated): 13
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ebaa Al Ozairi, MD; Phone Number: 3111 (+965) 22242999; Email: ebaa.alozairi@dasmaninstitute.org

Study Locations

• Kuwait
  • Kuwait City, Kuwait
    • Recruiting
    • Dasman Diabetes Institute
    • Contact: Ebaa Al Ozairi, MD
    • Contact: Dalal Alsaeed, PhD
    • Sub-Investigator: Carel Roux, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: α-MSH infusion; Pharmaceutical grade α-MSH will be dissolved in 0.9% saline containing 0.5% human albumin.	Other: α-MSH infusion; Pharmaceutical grade α-MSH is custom synthesized to GMP standards by Auspep (Australia www.auspep.com.au), a good manufacturing practice (GMP) accredited manufacturer of peptides, approved by the Therapeutic Goods Administration (TGA), European Medicines Agency (EMA) and U.S. Food and Drug Administration (FDA).
Placebo Comparator: Saline infusion; Saline infusion: Pharmaceutical GMP-grade sterile 0.5% human albumin dissolved in saline.	Other: Placebo solutions; Pharmaceutical GMP-grade sterile 0.5% human albumin dissolved in saline.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Difference in the total or incremental area under the curve of glucose and insulin concentration at an OGTT during saline vs. α-MSH infusion	12 months

Secondary Outcome Measures

Outcome Measure	Time Frame
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.	12 months

Other Outcome Measures

Outcome Measure	Time Frame
Difference in energy intake measured by an ad libitum meal test at the saline vs. α-MSH infusion	12 months
Adverse events (including flushing)	12 months

Collaborators and Investigators

• Sponsor: Dasman Diabetes Institute

Study record dates

Study Major Dates

• Study Start (Estimated): March 4, 2024
• Primary Completion (Estimated): April 4, 2024
• Study Completion (Estimated): April 4, 2024

Study Registration Dates

• First Submitted: February 28, 2024
• First Submitted That Met QC Criteria: March 4, 2024
• First Posted (Estimated): March 5, 2024

Study Record Updates

• Last Update Posted (Estimated): March 5, 2024
• Last Update Submitted That Met QC Criteria: March 4, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Type 2 Diabetes, Alpha-melanocyte stimulatory hormone (ɑ-MSH), OGTT
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: RAHM-2023-006

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No