Physiology of GIP(1-30)NH2 in Humans

Study Overview
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Brief Summary
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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.

Official Title
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Physiology of GIP(1-30)NH2 in Humans

Conditions
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Glucose Metabolism Disorders

Intervention / Treatment
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* Other: GIP(1-30)NH2
* Other: GIP(1-42)
* Other: Saline


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 30 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: GIP(1-42)<br> | Other: GIP(1-42)<br>* Intravenous administration of the peptide hormone GIP(1-42) during a stepwise glucose clamp<br>|
| Experimental: GIP(1-30)NH2<br> | Other: GIP(1-30)NH2<br>* Intravenous administration of the peptide hormone GIP(1-30)NH2 during a stepwise glucose clamp<br>|
| Placebo Comparator: Placebo<br> | Other: Saline<br>* Intravenous administration of saline during a stepwise glucose clamp<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Insulin |  | Up to 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 |