Clinical trial NCT03734718: The Role of Glucose-Dependent Insulinotropic Polypeptide in the Pathological Glucose Homeostasis Of Type 1 Diabetes
Official title: The Role of Glucose-dependent Insulinotropic Polypeptide in the Pathological Glucose Homeostasis of Type 1 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus, Type 1
Hypoglycemia
Keywords: Gastric Inhibitory Polypeptide
Diabetes Mellitus, Type 1
Hypoglycemia
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Glucagon
Incretin
Lead sponsor: Steno Diabetes Center Copenhagen
Sponsor class: OTHER
First posted: 2018-11-08
Enrollment: 20
Sex: MALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: placebo-controlled, double-blinded, 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 the daily life of participants with type 1 Diabetes


Eligibility criteria: 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

Primary outcomes:
measure: Blood glucose
timeFrame: an average of 6 days
Secondary outcomes:
measure: Incretin hormones
timeFrame: Evaluated at experimental day 0,1 and 6 of each intervention
measure: Free fatty acids (FFA)
timeFrame: Evaluated at experimental day 0,1 and 6 of each intervention
measure: Fat mRNA
timeFrame: At day 6, and 10 of the study
measure: Fat Protein content
timeFrame: Evaluated at experimental day 0,1 and 6 of each intervention
measure: Blood pressure
timeFrame: The first 24 hours of intervention and at experimental day 6
measure: Pulse
timeFrame: The first 24 hours of intervention and at experimental day 6
measure: Glucose regulatory hormones
timeFrame: Evaluated at experimental day 0,1 and 6 of each intervention
measure: Number of symptomatic hypoglycemic events
timeFrame: An average of 1 week
Other outcomes:
Locations:
city: Hellerup
country: Denmark
facility: Steno Diabetes Center CopenhagenSteno Diabetes Center Copenhagen, Clinical Metabolic Physiology
Study officials:
References:
citation: Heimburger SMN, Hoe B, Nielsen CN, Bergmann NC, Hartmann B, Holst JJ, Vilsboll T, Dejgaard TF, Christensen MB, Knop FK. The effect of 6-day subcutaneous glucose-dependent insulinotropic polypeptide infusion on time in glycaemic range in patients with type 1 diabetes: a randomised, double-blind, placebo-controlled crossover trial. Diabetologia. 2021 Nov;64(11):2425-2431. doi: 10.1007/s00125-021-05547-8. Epub 2021 Aug 17.