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

Steno Diabetes Center Copenhagen20 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

TRIPLE

Enrollment

Conditions

Diabetes Mellitus, Type 1 Hypoglycemia

Interventions

GIPDRUG

Infusion of Glucose-dependent insulinotropic peptide

Eligibility

Sex: MALEMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (1)

Steno Diabetes Center CopenhagenSteno Diabetes Center Copenhagen, Clinical Metabolic Physiology

Hellerup, Denmark

Outcomes

Primary Outcomes

Blood glucose

Time spent in hypoglycemia, near-normoglycemia and hyperglycemia

Time frame: an average of 6 days

Secondary Outcomes

Incretin hormones

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

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

Free fatty acids (FFA)

Incremental and total area under the Concentration-Time Curve

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

Fat mRNA

mRNA analysis of fat biopsies

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

Fat Protein content

Protein analysis of fat biopsies

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

Blood pressure

Changes in blood pressure, mm Hg

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

Pulse

Changes in pulse, beats per minute

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

Glucose regulatory hormones

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

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

Data from ClinicalTrials.gov

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