Clinical trial NCT03556098: Glucose-dependent Insulinotropic Polypeptide as a Safeguard Against Hypoglycemia in Patients With Type 1 Diabetes
Official title: Glucose-dependent Insulinotropic Polypeptide as a Safeguard Against Hypoglycemia in Patients With Type 1 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus, Type 1
Keywords: Diabetes Mellitus, Type 1
Hypoglycemia
Gastric Inhibitory Polypeptide
Glucagon
Incretin
Lead sponsor: Steno Diabetes Center Copenhagen
Sponsor class: OTHER
First posted: 2018-06-14
Enrollment: 12
Sex: MALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Double blinded, randomized, cross-over study
Primary purpose: BASIC_SCIENCE

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: plasma glucose concentration
timeFrame: 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
Secondary outcomes:
measure: Glucose regulatory hormones
timeFrame: At times (minute): - 30, 0, 15, 30, 60, 90, 120, 150, 180, 210, 240 on study days
measure: Incretin hormones
timeFrame: At times (minute): - 30, 0, 15, 30, 60, 90, 120, 150, 180, 210, 240 on study days
measure: GIP[3-30]
timeFrame: At times (minute): - 30, 0, 15, 30, 60, 90, 120, 150, 180, 210, 240 on study days
measure: Free fatty acids (FFA)
timeFrame: At times (minute): - 30, 0, 15, 30, 60, 90, 120, 150, 180, 210, 240 on study days
measure: Blood analysis of paracetamol as an assessment of gastric emptying
timeFrame: At times (minute): - 30, 0, 15, 30, 60, 90, 120, 150, 180, 210, 240 on study days
measure: Fat mRNA
timeFrame: At time 240 minute on study days
measure: Fat Lipoprotein lipase (LPL)
timeFrame: At time 240 minute on study days
measure: Fat Perilipin 4
timeFrame: At time 240 minute on study days
measure: Fat Fatty acid binding protein 4 (FABP4)
timeFrame: At time 240 minute on study days
measure: Fat Hormonse-sensitive lipase (HSL)
timeFrame: At time 240 minute on study days
measure: Fat Vascular endothelial growth factor 4 (VEGF-A)
timeFrame: At time 240 minute on study days
measure: Fat GIP receptor (GIPR)
timeFrame: At time 240 minute on study days
measure: Blood pressure
timeFrame: At times (minute): - 30, 0, 15, 30, 60, 90, 120, 150, 180, 210, 240 on study days
measure: Pulse
timeFrame: At times (minute): - 30, 0, 15, 30, 60, 90, 120, 150, 180, 210, 240 on study days
Other outcomes:
Locations:
city: Hellerup
country: Denmark
facility: Steno Diabetes Center Copenhagen, Clinical Metabolic Physiology
Study officials:
affiliation: Steno Diabetes Center Copenhagen, Clinical Metabolic Physiology
name: Filip K Knop, MD, PhD
role: STUDY_DIRECTOR
References: