Status:
ACTIVE_NOT_RECRUITING
A Series of Pilot Studies to Evaluate the haemoDynamic and mEtabolic Effects oF apelIn aNd rElaxin
Lead Sponsor:
Cambridge University Hospitals NHS Foundation Trust
Collaborating Sponsors:
University of Cambridge
AstraZeneca
Conditions:
Cardiovascular Diseases
Type 2 Diabetes Mellitus
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
Type two diabetes mellitus (T2DM) is a common, long term metabolic disorder characterised by hyperglycaemia (high blood glucose) resulting from insulin resistance and relative insulin insufficiency. T...
Detailed Description
An extensive body of evidence demonstrates a direct association between T2DM and cardiovascular complications and mortality. Unfortunately, current therapies for diabetes have failed to be translated ...
Eligibility Criteria
Inclusion
- Healthy participants
- Have given written informed consent to participate
- Aged 18 to 70 years inclusive
- Male or female
- Current non-smoker
- If female, either postmenopausal or on days 2-9 of menstrual cycle and negative pregnancy test performed on the day of the of visit
- BMI in range for studies 1 and 4: 18.5-24.9 kg/m2 with waist circumference lower than 88 centimetres (35 inches) for women or 102 cm (40 inches) for men, and/or body fat level less than 32 % for women or 25% for men
- BMI in range for studies 2 and 3: 18.5-30.0 kg/m2 without limitations in waist circumference or body fat level
- Overweight/obese participants
- Have given written informed consent to participate
- Aged 18 to 70 years inclusive
- Male or female
- Current non-smoker
- If female, either postmenopausal or on days 2-9 of menstrual cycle and negative pregnancy test performed on the day of the of visit
- BMI in range of 25-34.9 kg/m2 (inclusive) with either waist circumference higher than 88cm (35 inches) for women or 102 cm (40 inches) for men, and/or body fat levels in excess of 32% for women or 25% for men
- Participants with type 2 diabetes mellitus
- Have given written informed consent to participate
- Aged 18 to 70 years inclusive
- Male or female
- Current non-smoker
- If female, either postmenopausal or on days 2-9 of menstrual cycle and negative pregnancy test performed on the day of the of visit
- BMI in range of 25-34.9 kg/m2 (inclusive) with either waist circumference higher than 88cm (35 inches) for women or 102 cm (40 inches) for men, and/or body fat levels in excess of 32% for women or 25% for men
- Documented diagnosis of Type 2 Diabetes Mellitus, either diet controlled or treated with oral hypoglycaemic therapy
Exclusion
- Hypersensitivity to any of the study drugs or excipients
- Systemic Hypertension (sustained BP \>160/100mmHg) or hypotension (systolic BP below 90 mmHg)
- Known heart disease
- Implanted heart pace-maker or implantable cardioverter defibrillator (ICD)
- Known active malignancy
- Known renal failure (creatinine \>140µmol/L)
- Known neurological disease
- History of Scleroderma (Study 4 only)
- Current pregnancy, breast feeding
- Use of vasoactive medications or NSAIDS/aspirin within 24 hours of study visits
- Use of caffeine within 24 hours of study visits
- Current involvement in the active treatment phase of other research studies, (excluding observations/non-interventional)
- Second or third-degree AV block, sino-atrial block, sick sinus syndrome or sinus bradycardia
- Known HIV, hepatitis B or C
- Needle phobia
- Participants treated with formal anticoagulant therapy such as, but not limited to, heparin, warfarin or clopidogrel
- Diagnosis of Type 1 Diabetes Mellitus or current usage of insulin or other injectable drugs for the treatment of diabetes such as but not limited to GLP1 agonists
- BMI \<18.5
- Aged \<18 or \>70 years
- Any other clinical reason which may preclude entry in the opinion of the investigator
Key Trial Info
Start Date :
March 28 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2025
Estimated Enrollment :
170 Patients enrolled
Trial Details
Trial ID
NCT03449251
Start Date
March 28 2018
End Date
September 1 2025
Last Update
February 7 2024
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Addenbrooke's Hospital
Cambridge, Cambridgeshire, United Kingdom, CB20QQ