Protocol for Alpha MSH Infusion Study in Patients With Type 2 Diabetes

NCT06293664 | Recruiting DMC

• 1 other identifier: RAHM-2023-006
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

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).

Conditions

Type 2 Diabetes Mellitus

Keywords

Type 2 Diabetes, Alpha-melanocyte stimulatory hormone (ɑ-MSH), OGTT

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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 Outcomes (2)

• 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

Study Arms (2)

α-MSH infusion

EXPERIMENTAL

Pharmaceutical grade α-MSH will be dissolved in 0.9% saline containing 0.5% human albumin.

Other: α-MSH infusion

Saline infusion

PLACEBO COMPARATOR

Saline infusion: Pharmaceutical GMP-grade sterile 0.5% human albumin dissolved in saline.

Other: Placebo solutions

Interventions

α-MSH infusion OTHER

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).

α-MSH infusion

Placebo solutions OTHER

Pharmaceutical GMP-grade sterile 0.5% human albumin dissolved in saline.

Saline infusion

Eligibility Criteria

• Age: 21 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Dasman Diabetes Institute: lead

Study Sites (1)

Dasman Diabetes Institute

Kuwait City, Kuwait

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Central Study Contacts

Ebaa Al Ozairi, MD

CONTACT

(+965) 22242999; ebaa.alozairi@dasmaninstitute.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SCREENING
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: CMO

Model Details: The research involves a double-blinded, randomized, placebo-controlled crossover study to assess the therapeutic potential of α-MSH infusion in T2DM patients.

Study Record Dates

• First Submitted: February 28, 2024
• First Posted: March 5, 2024
• Study Start: March 4, 2024
• Primary Completion: April 4, 2024
• Study Completion: April 4, 2024
• Last Updated: March 5, 2024

Record last verified: 2024-02

Locations

KU (1)