Physiology of GIP(1-30)NH2 in Humans

NCT04792762 | Completed

• 1 other identifier: H-17039726
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Insulin

  Up to 3 months

Secondary Outcomes (5)

• Glucagon

  Up to 3 months

• C-peptide

  Up to 3 months

• Glucose

  Up to 3 months

• CTX

  Up to 3 months

• P1NP

  Up to 3 months

Study Arms (3)

GIP(1-42)

EXPERIMENTAL

Other: GIP(1-42)

GIP(1-30)NH2

EXPERIMENTAL

Other: GIP(1-30)NH2

Placebo

PLACEBO COMPARATOR

Other: Saline

Interventions

GIP(1-30)NH2 OTHER

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

GIP(1-30)NH2

GIP(1-42) OTHER

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

GIP(1-42)

Saline OTHER

Intravenous administration of saline during a stepwise glucose clamp

Placebo

Eligibility Criteria

• Age: 20 Years - 30 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Gentofte, Copenhagen: lead

Study Sites (1)

Clinical Metabolic Physiology

Hellerup, 2900, Denmark

Location

MeSH Terms

Conditions

Glucose Metabolism Disorders

Interventions

gastric inhibitory polypeptide (1-42); Sodium Chloride

Condition Hierarchy (Ancestors)

Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 6, 2021
• First Posted: March 11, 2021
• Study Start: June 12, 2018
• Primary Completion: August 23, 2018
• Study Completion: June 9, 2019
• Last Updated: March 11, 2021

Record last verified: 2021-03

Locations

DK (1)