Physiology of GIP(1-30)NH2 in Humans

Glucose Metabolism Disorders Clinical Trial

— GA-11  

Official title:

Physiology of GIP(1-30)NH2 in Humans

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04792762
• Other study ID #: H-17039726
• Status: Completed
• Phase: N/A
• Start date: June 12, 2018
• Est. completion date: June 9, 2019

Study information

• Verified date: March 2021
• Source: University Hospital, Gentofte, Copenhagen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9
• Est. completion date: June 9, 2019
• Est. primary completion date: August 23, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 20 Years to 30 Years

Eligibility

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

Related Conditions & MeSH terms

• Glucose Metabolism Disorders
• Metabolic Diseases

Intervention

Other:
• GIP(1-30)NH2
Intravenous administration of the peptide hormone GIP(1-30)NH2 during a stepwise glucose clamp
• GIP(1-42)
Intravenous administration of the peptide hormone GIP(1-42) during a stepwise glucose clamp
• Saline
Intravenous administration of saline during a stepwise glucose clamp

Locations

Country	Name	City	State
Denmark	Clinical Metabolic Physiology	Hellerup

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Gentofte, Copenhagen

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Insulin		Up to 3 months
Secondary	Glucagon		Up to 3 months
Secondary	C-peptide		Up to 3 months
Secondary	Glucose		Up to 3 months
Secondary	CTX		Up to 3 months
Secondary	P1NP		Up to 3 months