Infusion of Alpha MSH to Improve Glucose Tolerance in Type 2 Diabetes
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
This study is testing if an infusion of a hormone called alpha-MSH can help people with Type 2 diabetes better manage their blood sugar levels.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 13 (estimated) |
| Ages | 21 Years to 50 Years |
| Sex | All |
| Sponsor | Dasman Diabetes Institute Academic / other |
| Locations | 1 site (Kuwait City) |
| Trial ID | NCT06293664 on ClinicalTrials.gov |
What this trial studies
This study investigates the effects of alpha-melanocyte stimulating hormone (α-MSH) infusion on glucose tolerance in patients with Type 2 Diabetes Mellitus (T2DM). It is a double-blinded, randomized, placebo-controlled crossover study that aims to determine if α-MSH can enhance glucose uptake in skeletal muscle, thereby improving glucose clearance. Participants will receive either α-MSH or a placebo, and their glucose tolerance will be measured to assess the hormone's efficacy. The study builds on pre-clinical findings that suggest α-MSH may improve glucose metabolism.
Who should consider this trial
Good fit: Ideal candidates are adults with Type 2 Diabetes who are stable on oral or injectable medications but not using insulin.
Not a fit: Patients with a history of type 1 diabetes or significant cardiovascular, respiratory, or other serious health conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a novel approach to improving glucose tolerance in patients with Type 2 Diabetes, potentially leading to better management of the condition.
How similar studies have performed: While pre-clinical studies have shown promise, this specific approach using α-MSH in humans with T2DM is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Kuwait City
- Dasman Diabetes Institute — Kuwait City, Kuwait (Recruiting)
Study contacts
- Study coordinator: Ebaa Al Ozairi, MD
- Email: ebaa.alozairi@dasmaninstitute.org
- Phone: (+965) 22242999
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.