Does an infusion of alpha-melanocyte stimulating hormone reduce blood sugar after a sugary drink in healthy people and those with type 1 diabetes mellitus?
- Conditions
- Glucose clearance from the bloodNutritional, Metabolic, Endocrine
- Registration Number
- ISRCTN26265036
- Lead Sponsor
- Imperial College London
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Ongoing
- Sex
- All
- Target Recruitment
- 59
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method