Effect of exenatide once weekly on gastric emptying in healthy subjects..
- Conditions
- Type 2 DiabetesMetabolic and Endocrine - Diabetes
- Registration Number
- ACTRN12616000955415
- Lead Sponsor
- Royal Adelaide Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 32
1. Healthy male subjects aged 55 – 70 years
2. Healthy post-menopausal female subjects between 55 – 70 years (Postmenopausal” will be defined as greater than or equal to 55 y of age or at least 12 months since last menses). Post-menopausal will be defined as amenorrhoea for at least 12 months or more, following cessation of all exogenous hormonal treatments and FSH levels in the post-menopausal range.
3. Body mass index (BMI) 25 – 35 kg/m2
4. Haemoglobin and ferritin in the normal range for gender and age.
5. Subject has provided written informed consent.
1. Evidence of renal disease (i.e. a creatinine clearance cut-off of less than 50 ml/min. Calculated creatinine clearance will be determined as follows using the Cockcroft-Gault equation: Cr clearance = [140 - age (years) x weight (kg)] / [0.814 x serum creatinine (micromol/L)] (For female subjects, multiply Cr clearance x 0.85)).
2. Iron stores, or liver function tests outside the following ranges:
- Alanine aminotransferase (ALT): less than 55 U/L
- Alkaline phosphatase (ALP): 30 - 110 U/L
- Aspartate transaminase (AST): less than 45 U/L
- Total bilirubin: 2 - 24 micromol/L
- Haemoglobin: 115 – 165 g/L (Females); 130 – 180 g/L (Males)
- Ferritin: 15 – 200 micrograms/L (Females); 30 – 300 micrograms/L (Males)
3. Hepatic or cardiovascular disease, pancreatitis (subjects with past history of acute or chronic pancreatitis, or amylase or lipase levels greater than 2 fold upper limit of normal at screening, gastric surgery, or known gastroparesis on history or screening biochemistry tests.
4. Subjects with any history of cancer, except for basal cell carcinoma or in situ carcinoma of the cervix treated with apparent success with curative therapy equal to 12 months prior to screening or other malignancies treated with apparent success with curative therapy equal to 5 years prior to screening will be excluded.
5. History of any clinically significant disease or disorder which may either put the volunteer at risk because of participation in the study, or influence the results or the volunteer’s ability to participate in the study.
6. Serum calcitonin level at screening suggestive of thyroid c-cell hyperplasia (greater than 50 nanogram/l). Personal or family history of medullary thyroid cancer or Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).
7. History of hyperthyroidism or uncontrolled hypothyroidism.
8. Evidence of diabetes based on history or HbA1c equal to 6.5% at screening.
9. Use of drugs potentially affecting gastrointestinal motility (these include but are not limited to the following medications: opiates, anticholinergics, levodopa, beta blockers, clonidine, nitrates, tricyclic antidepressants, selective serotonin re-uptake inhibitors, phosphodiesterase type 5 inhibitors, sumatriptan, metoclopramide, domperidone, cisapride, tegaserod, or erythromycin)
10. Current history of smoking or consumption of greater than 2 units alcohol daily on a regular basis
11. Known or suspected history of alcohol or drug abuse, as judged by the Investigator.
12. History of severe allergy/hypersensitivity or ongoing allergy/hypersensitivity, or history of hypersensitivity to exenatide or drugs with a similar chemical structure or its components.
13. Known hypersensitivity to heparin or IV infusion equipment, plastics, adhesive or silicone, or know history of hypotension or infusion site reactions with IV administration of other medicines
14. Systolic BP less than 90mmHg or greater than 140mmHg; Diastolic BP less than 50mmHg or greater than 90mmHg; Heart rate less than 45 or greater 85 beats per minute at the screening test.
15. Plasma donation within 1 month of screening or blood donation / loss greater than 500ml during the 3 months prior to screening.
16. Participation in any research studies involving exposure to ionising radiation within the previous 12 months
17. Vegetarian diet
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To compare the effect of 8 weeks treatment with exenatide QW (once weekly) versus placebo on gastric emptying, measured by scintigraphy. [8 weeks]
- Secondary Outcome Measures
Name Time Method