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OpenTrials
Completed

NCT Number: NCT03734718

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

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

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Key information

Conditions

Diabetes Mellitus, Type 1 Autoimmune Diseases Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Hypoglycemia Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–75 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Steno Diabetes Center CopenhagenSteno Diabetes Center Copenhagen, Clinical Metabolic Physiology

Hellerup, 2800, Denmark

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

GIP

Drug

Infusion of Glucose-dependent insulinotropic peptide

Primary outcomes

  1. Blood glucose

    Time frame: an average of 6 days

    Time spent in hypoglycemia, near-normoglycemia and hyperglycemia

Secondary outcomes

  1. Incretin hormones

    Time frame: Evaluated at experimental day 0,1 and 6 of each intervention

    Incretin hormones GLP-1 and GIP. Incremental and total area under the Concentration-Time Curve

  2. Free fatty acids (FFA)

    Time frame: Evaluated at experimental day 0,1 and 6 of each intervention

    Incremental and total area under the Concentration-Time Curve

  3. Fat mRNA

    Time frame: At day 6, and 10 of the study

    mRNA analysis of fat biopsies

  4. Fat Protein content

    Time frame: Evaluated at experimental day 0,1 and 6 of each intervention

    Protein analysis of fat biopsies

  5. Blood pressure

    Time frame: The first 24 hours of intervention and at experimental day 6

    Changes in blood pressure, mm Hg

  6. Pulse

    Time frame: The first 24 hours of intervention and at experimental day 6

    Changes in pulse, beats per minute

  7. Glucose regulatory hormones

    Time frame: Evaluated at experimental day 0,1 and 6 of each intervention

    Counter regulatory hormones: glucagon, noradrenalin, cortisol, somatotropin, and insulin/c-peptide. Incremental and total area under the Concentration-Time Curve

  8. Number of symptomatic hypoglycemic events

    Time frame: An average of 1 week

    Self-reported events

Sponsors and collaborators

Lead sponsor

Steno Diabetes Center Copenhagen

Other

Registry information

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Nov 8, 2018
Registry last updated
Jan 27, 2020

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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