Physiology of GIP(1-30)NH2 in Humans

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04792762

Acronym

GA-11

Enrollment

Registered

2021-03-11

Start date

2018-06-12

Completion date

2019-06-09

Last updated

2021-03-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Glucose Metabolism Disorders

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.

Interventions

OTHERGIP(1-30)NH2

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

OTHERGIP(1-42)

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

OTHERSaline

Intravenous administration of saline during a stepwise glucose clamp

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

BASIC_SCIENCE

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

MALE

Age

20 Years to 30 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
Insulin	Up to 3 months

Secondary

Measure	Time frame
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

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026