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Physiology of GIP(1-30)NH2 in Humans (GA-11)

U

University Hospital, Gentofte, Copenhagen

Status

Completed

Conditions

Glucose Metabolism Disorders

Treatments

Other: Saline
Other: GIP(1-30)NH2
Other: GIP(1-42)

Study type

Interventional

Funder types

Other

Identifiers

NCT04792762
H-17039726

Details and patient eligibility

About

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.

Enrollment

9 patients

Sex

Male

Ages

20 to 30 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Basic Science

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Double Blind

9 participants in 3 patient groups, including a placebo group

GIP(1-42)
Experimental group
Treatment:
Other: GIP(1-42)
GIP(1-30)NH2
Experimental group
Treatment:
Other: GIP(1-30)NH2
Placebo
Placebo Comparator group
Treatment:
Other: Saline

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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