Physiology of GIP(1-30)NH2 in Humans

Not Applicable

Completed

• Conditions: Glucose Metabolism Disorders
• Interventions: Other: Saline; Other: GIP(1-42); Other: GIP(1-30)NH2

• Registration Number: NCT04792762
• Lead Sponsor: University Hospital, Gentofte, Copenhagen

Brief Summary

Glucose-dependent insulinotropic polypeptide (GIP) is a gut-derived incretin hormone that affects glucose, lipid and bone metabolism. Secretion of GIP into the blood stream from enteroendocrine cells is stimulated bu nutrients in the gut lumen and results in potentiation of glucose stimulated insulin secretion from the pancreas. The objective of this study is to investigate the physiology of GIP(1-30)NH2 in humans with insulin secretion as the primary endpoint. Furthermore the effects on on plasma/serum levels of glucagon, C-peptide, glucose, bone markers (CTX and P1NP) will be measured.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-06-12
• Primary Completion: 2018-08-23
• Study Completion: 2019-06-09
• Status Verified: 2021-03
• Study First Submitted: 2021-03-06
• Study First Submitted QC: 2021-03-10
• Last Update Submitted: 2021-03-10
• Study First Posted: 2021-03-11
• Last Update Posted: 2021-03-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 9

Inclusion Criteria

• Healthy men of Northern European descent
• BMI: 19-25 kg/m2
• Stable body weight (±5%) in the last three months

Exclusion Criteria

• Treatment with medication or dietary supplements that cannot be paused for 12 hours
• More than 14 units of alcohol per week or abuse of narcotics
• Established liver disease and/or plasma alanine aminotransferase (ALT) ≥3 × normal value and/or INR outside the normal range
• Renal impairment (eGFR <60 ml/min/1.73 m2)
• Severe arteriosclerotic heart disease or severe heart failure (NYHA group III or IV)
• Low blood count (haemoglobin <8.3 mol/l)
• Special diet or planned body weight change before the trial period
• First-degree relatives with diabetes
• Participation in other clinical experiments with medication
• Any disease/condition that the investigators estimate disturbing for the participation in the experiment

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Placebo	Saline	-
GIP(1-42)	GIP(1-42)	-
GIP(1-30)NH2	GIP(1-30)NH2	-

Primary Outcome Measures

Name	Time	Method
Insulin	Up to 3 months

Secondary Outcome Measures

Name	Time	Method
Glucagon	Up to 3 months
Glucose	Up to 3 months
P1NP	Up to 3 months
C-peptide	Up to 3 months
CTX	Up to 3 months

Trial Locations

Locations (1)

Clinical Metabolic Physiology; 🇩🇰 Hellerup, Denmark