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The Role of Glucose-Dependent Insulinotropic Polypeptide in the Pathological Glucose Homeostasis Of Type 1 Diabetes

S

Steno Diabetes Centers

Status

Completed

Conditions

Hypoglycemia
Diabetes Mellitus, Type 1

Treatments

Drug: GIP

Study type

Interventional

Funder types

Other

Identifiers

NCT03734718
H-18015379 (Other Identifier)
GIPHOT

Details and patient eligibility

About

In the present project the investigators will evaluate whether glucagonotropic properties of the gut-derived incretin hormone glucose-dependent insulinotropic polypeptide (GIP) may be utilized as a safeguard against hypoglycemia in the daily life of participants with type 1 Diabetes

Enrollment

20 patients

Sex

Male

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Body mass index between 20 and 27 kg/m2
  • T1D (diagnosed according to the criteria of the World Health Organization) with HbA1c <69 mmol/mol (<8.5%)
  • Treatment with a stable insulin regimen ≥3 months
  • T1D duration between 2 and 15years
  • C-peptide negative (C-peptide ≤ 16 ng/ml)
  • Informed consent

Exclusion criteria

  • Anemia (hemoglobin outside normal range)
  • Known liver disease and/or ALAT and/or ASAT > 2 times normal values
  • Estimated glomerular filtration rate (eGFR) ≤60 ml/min/1.73 m2 or albuminuria
  • Prior Cardiovascular events and/or abnormal heart rate/blood pressure
  • Use of anti-diabetic medicine (other than insulin), corticosteroids or other drugs affecting glucose metabolism during the study period or within 30 days prior to randomization
  • Any physical or psychological condition that the investigator feels would interfere with trial participation

Trial design

Primary purpose

Basic Science

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Triple Blind

20 participants in 2 patient groups, including a placebo group

Glucose-Dependent Insulinotropic Polypeptide
Active Comparator group
Description:
6-day continuous infusion of Glucose-Dependent Insulinotropic Polypeptide
Treatment:
Drug: GIP
Placebo
Placebo Comparator group
Description:
Saline
Treatment:
Drug: GIP

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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