ISRCTN26265036进行中（未招募）未知
A physiological study of the effect of alpha-MSH on glucose clearance in healthy participants and those with type 1 diabetes mellitus
适应症
试验速览
- 阶段
- 未知
- 状态
- 进行中（未招募）
- 入组人数
- 59
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •Current participant inclusion criteria as of 19/11/2021:
- •Work Package 1 and 2:
- •1. 18-50 years old
- •2. Normal fasting glucose (< 5.6 mmol/l)
- •3. Stable body weight for at least 3 months
- •4. BMI =18 and <30 kg/m²
- •5. The participant is capable of giving written informed consent
- •6. The participant is able to read, comprehend and record information written in English
- •Work Package 3:
- •1. 18-50 years old
- •2. Diagnosis of T1DM with low/undetectable plasma C-peptide
- •3. Stable body weight for at least 3 months
- •4. BMI =18 and <30 kg/m²
- •5. The participant is capable of giving written informed consent
- •6. The participant is able to read, comprehend and record information written in English
- •Previous participant inclusion criteria:
- •1. 18-50 years old
- •2. Normal fasting glucose (< 5.6 mmol/l)
- •3. Stable body weight for at least 3 months
- •4. BMI > = 18 < 30 kg/m²
- •5. The participant is capable of giving written informed consent
- •6. The participant is able to read, comprehend and record information written in English
排除标准
- •1. Previous or current psychiatric diagnosis listed in DSM-V Axis 1
- •2. Significant current or past medical or psychiatric history that, in the opinion of the investigators, contraindicates their participation
- •3. History of type 1 or type 2 diabetes mellitus
- •4. History of endocrine disorder
- •5. History of ischaemic heart disease, hypertension, heart failure, cardiac arrhythmia, peripheral vascular or cerebrovascular disease.
- •6. 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
- •7. Unwillingness or inability to follow the procedures outlined in the protocol
- •8. 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
- •9. Use of current regular prescription or over-the-counter medications that in the opinion of the Investigators may affect participant safety or outcome measures
- •10. 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
- •11. Current pregnancy or breast-feeding in female participants (the Investigators would advise on using contraception for the duration of the visits)
- •12. 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
- •13. 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)
- •14. Exposure to more than 3 new investigational medicinal products within 12 months prior to the screening
- •15. Participants who have donated, or intend to donate, blood within three months before the screening visit or following study visit completion
研究者
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