Evaluating the effects of the gut hormone, glucose-dependent insulinotropic polypeptide (GIP) on stomach emptying, blood pressure, gut blood flow and blood sugar levels in healthy older subjects

Phase 1

Completed

• Conditions: postprandial hypotension; Cardiovascular - Other cardiovascular diseases

• Registration Number: ACTRN12624000534583
• Lead Sponsor: niversity of Adelaide

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Completion: 2023-12-22
• Study Start: 2024-04-30
• Last Update Posted: 6 May 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 18

Inclusion Criteria

• Male or female healthy participants
• Body Mass Index (BMI) 19 - 35 kg/m²

Exclusion Criteria

•Participants with diabetes, a history of severe respiratory, cardiovascular, hepatic and/or renal disease (severe in that the social or physical manifestation of the disease, or living with the condition, impact negatively and significantly on the individuals’ ability to lead a normal day to day life), chronic alcohol abuse or epilepsy (excluded by history) or if iron status, or liver function tests are outside the following ranges:
•Alanine aminotransferase (ALT)0 - 55 U/L
•Alkaline phosphatase30 - 110 U/L
•Aspartate transaminase0 - 45 U/L
•Amylase and/or lipase>3 x ULN
•Bilirubin6 - 24 mmol/L
•Ferritin15 – 200 ng/mL (Females)
30 – 300 ng/mL (Males)
•Haemoglobin115 - 155 g/L (Females)
135 – 172 g/L (Males)

•Participants with a creatinine clearance cut-off of < 50 ml/min
Calculated creatinine clearance will be determined as follows (29):
Cr clearance = [140 - age (years) x weight (kg)] / [0.814 x serum creatinine (µmol/L)]
(For female subjects, multiply Cr clearance x 0.85)
•Participants requiring medication likely to influence BP or gastrointestinal function
•Participants with a past history of gastrointestinal disease, including known gastroparesis, significant upper gastrointestinal symptoms and previous gastric surgery
•Participants with a history of unexplained pancreatitis, chronic pancreatitis, pancreatectomy,
•Participants with a current or prior history of c-cell carcinoma
•Smoking > 10 cigarettes/day
•Alcohol consumption > 20 g/day
•Participants who have donated blood in the previous 12 weeks

Study & Design

• Study Type: Interventional
• Study Design: Not specified