A prospective randomised double-blind, double-dummy, placebo-controlled crossover study to determine whether Glucagon-like peptide-1 (GLP-1) stimulates or suppresses pancreatic exocrine function in health.

A prospective randomised double-blind, double-dummy, placebo-controlled crossover study on 15 healthy male participants to determine whether Glucagon-like peptide-1 (GLP-1) stimulates or suppresses pancreatic exocrine function in health.

Status

Withdrawn

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12614000815662

Enrollment

Registered

2014-07-31

Start date

2016-06-01

Completion date

2017-02-10

Last updated

2021-06-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

OUTCOMES The primary outcome measures are *peak duodenal bicarbonate concentration and pancreatic bicarbonate output (bicarbonate volume times bicarbonate concentration) *peak duodenal amylase concentration and amylase concentration area under the curve (time equals 0 to 60 minutes) Secondary outcome measures are *Plasma concentrations of amylase and lipase

Interventions

IV GLP-1 (1.2 pmol/kg/min) infusion or placebo will be administrated to participants over 2 visits. Participants will receive a second IV containing either Secretin (75ng/kg/hr) and CCK (20ng/kg/hr) or placebo over 2 visits. Adherence of intervention will be monitored by both the clinical trial pharmacy and the researchers in the study to ensure the participants receive the correct treatment/placebo on any given trial day. Participants will be studied over 4 occasions, separated by at least 4 da

Study design

Allocation

Randomised controlled trial

Intervention model

Crossover

Primary purpose

Treatment

Masking

Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

Male

Age

18 Years to 35 Years

Healthy volunteers

Yes

Inclusion criteria

Healthy Male volunteers between the ages of 18-35

Exclusion criteria

Inability to give informed consent History of diabetes History of pancreatitis Lipase level >210 U/L Amylase level > 110 U/L Estimated glomerular filtration rate < 60ml/min Impared liver function (ALT >55 U/L; Albumin <34g/l, ALP >110 U/L; Bilirubin >25 umol; GGT > 80 U/L) Haemoglobin <135g/L HbA1c >6% Body Mass Index >32kg/m2 Smoking > 10 cigarettes/day Alcohol consumption >20g/day Volunteers who have donated blood in the preceding 3 months Female volunteers of child bearing age Suffer from any chronic medical conditions such as (but not limited to) heart failure, ischaemic heart disease, chronic lung disease, autonomic dysfunction resulting from any cause active or previously treated malignancy, chronic infections (e.g viral hepatitis and HIV) Suffered from any acute medical illnesses during the 4 week period before recruitment Contraindications to any of the drugs used in this study (e.g. known hypersensitivity) Gallstone(s) visualised on ultrasound at the screening visit.

Outcome results