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OpenTrials
Completed

NCT Number: NCT04792762

Physiology of GIP(1-30)NH2 in Humans

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.

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Key information

Conditions

Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

20 year–30 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Clinical Metabolic Physiology

Hellerup, 2900, Denmark

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

GIP(1-30)NH2

Other

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

GIP(1-42)

Other

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

Saline

Other

Intravenous administration of saline during a stepwise glucose clamp

Primary outcomes

  1. Insulin

    Time frame: Up to 3 months

Secondary outcomes

  1. Glucagon

    Time frame: Up to 3 months

  2. C-peptide

    Time frame: Up to 3 months

  3. Glucose

    Time frame: Up to 3 months

  4. CTX

    Time frame: Up to 3 months

  5. P1NP

    Time frame: Up to 3 months

Sponsors and collaborators

Lead sponsor

University Hospital, Gentofte, Copenhagen

Other

Registry information

Acronym: GA-11

Important dates

Study start
2018
Primary completion
2018
Study completion
2019
First posted
Mar 11, 2021
Registry last updated
Mar 11, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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