Physiology of GIP(1-30)NH2 in Humans

NCT ID: NCT04792762

Last Updated: 2021-03-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 9 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-06-12
• Study Completion Date: 2019-06-09

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.

Conditions

Glucose Metabolism Disorders

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: DOUBLE

Study Groups

GIP(1-42)

Group Type: EXPERIMENTAL

GIP(1-42)

Intervention Type: OTHER

Intravenous administration of the peptide hormone GIP(1-42) during a stepwise glucose clamp

GIP(1-30)NH2

Group Type: EXPERIMENTAL

GIP(1-30)NH2

Intervention Type: OTHER

Intravenous administration of the peptide hormone GIP(1-30)NH2 during a stepwise glucose clamp

Placebo

Group Type: PLACEBO_COMPARATOR

Saline

Intervention Type: OTHER

Intravenous administration of saline during a stepwise glucose clamp

Interventions

GIP(1-30)NH2

Intravenous administration of the peptide hormone GIP(1-30)NH2 during a stepwise glucose clamp

Intervention Type: OTHER

GIP(1-42)

Intravenous administration of the peptide hormone GIP(1-42) during a stepwise glucose clamp

Intervention Type: OTHER

Saline

Intravenous administration of saline during a stepwise glucose clamp

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 30 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

University Hospital, Gentofte, Copenhagen

OTHER

Sponsor Role: lead

Responsible Party

Filip Krag Knop

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Clinical Metabolic Physiology

Hellerup, , Denmark

Countries

Denmark

Other Identifiers

H-17039726

Identifier Type: -

Identifier Source: org_study_id