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Completed

NCT Number: NCT03556098

Glucose-dependent Insulinotropic Polypeptide as a Safeguard Against Hypoglycemia in Patients With 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 patients with T1D.

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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–70 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Steno Diabetes Center Copenhagen, Clinical Metabolic Physiology

Hellerup, 2900, Denmark

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Caucasian men
  • Body mass index between 20-27 kg/m^2
  • T1D (diagnosed according to the criteria of the World Health Organization) with HbA1c<69 mmol/l (<8,5%)
  • T1D duration between 2-20 years
  • Stimulated C-peptide ≤ 100 pmol/mL)
  • Treatment with a stable basal bolus or insulin pump regimen ≥ 3 months
  • Informed consent

Exclusion criteria

  • Anemia (hemoglobin below normal range)
  • Liver disease (ALAT and/or ASAT >2 times normal values) or history of hepatobiliary disorder
  • Nephropathy (serum creatinine above normal range and/or albuminuria)
  • Allergy or intolerance to ingredients included in the standardized meals
  • Prior myocardial infarction or other cardiac events
  • Any physical or psychological condition that the investigator fells would interfere with trial participation
  • Treatment with any glucose-lowering drugs beside insulin

Treatment and study plan

glucose-dependent insulinotropic peptide

Drug

Infusion of GIP

Glucose-Dependent Insulin-Releasing Hormone[3-30]

Drug

Infusion of GIP antagonist GIP[3-30]

Saline Solution

Drug

Infusion of Saline

Other names: Placebo

Primary outcomes

  1. plasma glucose concentration

    Time frame: At times (minute): - 30, - 15, 0, 15, 30, 45, 60, 75, 90, 105, 120, 135, 150, 165, 180, 195, 210, 225, 240 on study days

    plasma glucose excursions and plasma glucose nadir

Secondary outcomes

  1. Glucose regulatory hormones

    Time frame: At times (minute): - 30, 0, 15, 30, 60, 90, 120, 150, 180, 210, 240 on study days

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

  2. Incretin hormones

    Time frame: At times (minute): - 30, 0, 15, 30, 60, 90, 120, 150, 180, 210, 240 on study days

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

  3. GIP[3-30]

    Time frame: At times (minute): - 30, 0, 15, 30, 60, 90, 120, 150, 180, 210, 240 on study days

    GIP[3-30]. Incremental and total area under the Concentration-Time Curve

  4. Free fatty acids (FFA)

    Time frame: At times (minute): - 30, 0, 15, 30, 60, 90, 120, 150, 180, 210, 240 on study days

    Free fatty acids(FFA). Incremental and total area under the Concentration-Time Curve

  5. Blood analysis of paracetamol as an assessment of gastric emptying

    Time frame: At times (minute): - 30, 0, 15, 30, 60, 90, 120, 150, 180, 210, 240 on study days

    Assessment of gastric emptying

  6. Fat mRNA

    Time frame: At time 240 minute on study days

    Fat biopsy to evaluate changes in fat mRNA

  7. Fat Lipoprotein lipase (LPL)

    Time frame: At time 240 minute on study days

    Fat biopsy to evaluate LPL changes in fat

  8. Fat Perilipin 4

    Time frame: At time 240 minute on study days

    Fat biopsy to evaluate Perilipin 4 changes in fat

  9. Fat Fatty acid binding protein 4 (FABP4)

    Time frame: At time 240 minute on study days

    Fat biopsy to evaluate Fatty acid binding protein 4 (FABP4) changes in fat

  10. Fat Hormonse-sensitive lipase (HSL)

    Time frame: At time 240 minute on study days

    Fat biopsy to evaluate Hormonse-sensitive lipase (HSL) changes in fat

  11. Fat Vascular endothelial growth factor 4 (VEGF-A)

    Time frame: At time 240 minute on study days

    Fat biopsy to evaluate Vascular endothelial growth factor 4 (VEGF-A) changes in fat

  12. Fat GIP receptor (GIPR)

    Time frame: At time 240 minute on study days

    Fat biopsy to evaluate GIP receptor (GIPR) changes in fat

  13. Blood pressure

    Time frame: At times (minute): - 30, 0, 15, 30, 60, 90, 120, 150, 180, 210, 240 on study days

    Changes in blood pressure, mm Hg

  14. Pulse

    Time frame: At times (minute): - 30, 0, 15, 30, 60, 90, 120, 150, 180, 210, 240 on study days

    Changes in pulse, beats per minute

Sponsors and collaborators

Lead sponsor

Steno Diabetes Center Copenhagen

Other

Registry information

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Jun 14, 2018
Registry last updated
May 10, 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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