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
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 13
- 试验地点
- 1
- 主要终点
- Difference in the total or incremental area under the curve of glucose and insulin concentration at an OGTT during saline vs. α-MSH infusion
研究概览
简要总结
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).
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Screening
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Previous or current psychiatric diagnosis listed in DSM-V Axis
- •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.
研究组 & 干预措施
α-MSH infusion
Pharmaceutical grade α-MSH will be dissolved in 0.9% saline containing 0.5% human albumin.
干预措施: α-MSH infusion (Other)
Saline infusion
Saline infusion: Pharmaceutical GMP-grade sterile 0.5% human albumin dissolved in saline.
干预措施: Placebo solutions (Other)
结局指标
主要结局
Difference in the total or incremental area under the curve of glucose and insulin concentration at an OGTT during saline vs. α-MSH infusion
时间窗: 12 months
次要结局
- 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)
研究者
Dr. Ebaa Al Ozairi
CMO
Dasman Diabetes Institute