Effects of Glucagon-Like Peptide-1 (GLP-1) administration on gastric emptying during periods of hyperglycaemia in healthy volunteers.

Phase 2

Completed

• Conditions: Glycaemic control and gastric emptying; Metabolic and Endocrine - Other metabolic disorders

• Registration Number: ACTRN12613001384741
• Lead Sponsor: Dr Mark Plummer

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-12-17
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

15 healthy volunteers, with no history of diabetes, minimal alcohol and nicotine consumption and BMI <32, aged 50-80 years

Exclusion Criteria

Exclusion criteria will comprise
-Inability to give informed consent
-Known diabetes mellitus or a glycated haemoglobin (HbA1c) >/=6.5%
-Abnormal ferritin levels, haemoglobin levels or liver function on screening
-Previous gastrointestinal surgery
-Taking medications known to affect gastrointestinal motility or blood sugar.
This includes: insulin, oral hypoglycaemic agents (metformin, sulphonylureas, acarbose), antibiotics, steroids, proton pump inhibitors, amtiemetics, prokinetic agents and H2 receptor antagonists.
-Body Mass Index >32kg/m2
-Smoking >10 cigarettes/day
-Alcohol consumption >20g/day
-Previous exposure to radiation for research purposes in the preceding 12 months
-Volunteers who have donated blood in the preceding 3 months
-Female volunteers of child bearing age who are pregnant or lactating, or who have inadequate contraception
-Suffer from any chronic medical condition such as (but not limited to) heart failure, ischaemic heart disease, chronic lung disease, autonomic dysfunction resulting from any cause, active or previously treatment malignancy, chronic infections (e.g. viral hepatitis and HIV)
-Taking any prescription or over the counter medications other than simple analgesics (e.g. paracetamol)
-Suffered from any acute medical illness (e.g. upper respiratory tract infection, pneumonia...etc) during the 4 week period before recruitment

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Gastric emptying will be assessed via Scinitgraphy [Gastric emptying will be measured for four hours from t=30 min to t=4.5 hours.]

Secondary Outcome Measures

Name	Time	Method
Glucose absorption will be measured using 3-OMG concentrations.[Blood samples for hormone concentrations will be taken every 15 minutes, from t=0 to t=4.5.];Plasma concentrations of GIP, GLP-1 and glucagon will be measured[Blood samples for hormone concentrations will be taken every 15 minutes, from t=0 to t=4.5.];The amount of IV glucose used to maintain glycaemia will also be recorded[This will be the total glucose infused during the glycaemic clamp (4.5 hours).];Blood glucose concentrations[Blood glucose will be monitored every 5 minutes from t=0 min to t=2 hours. Blood glucose will be monitored every 15 minutes from t=2 hours to t=4.5 hours]