Diabetes Mellitus, Type 1, Hypoglycemia
Conditions
Keywords
Gastric Inhibitory Polypeptide, Diabetes Mellitus, Type 1, Hypoglycemia, Glucose Metabolism Disorders, Metabolic Diseases, Endocrine System Diseases, Glucagon, Incretin
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
Interventions
DRUGGIP
Infusion of Glucose-dependent insulinotropic peptide
Sponsors
Steno Diabetes Center Copenhagen
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
TRIPLE (Subject, Caregiver, Investigator)
Masking description
The peptides/placebo is prepared, in a randomized fashion, by a laboratory assistant.
Intervention model description
placebo-controlled, double-blinded, cross-over study
Eligibility
Sex/Gender
MALE
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Blood glucose | an average of 6 days | Time spent in hypoglycemia, near-normoglycemia and hyperglycemia |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Fat mRNA | At day 6, and 10 of the study | mRNA analysis of fat biopsies |
| Fat Protein content | Evaluated at experimental day 0,1 and 6 of each intervention | Protein analysis of fat biopsies |
| Blood pressure | The first 24 hours of intervention and at experimental day 6 | Changes in blood pressure, mm Hg |
| Free fatty acids (FFA) | Evaluated at experimental day 0,1 and 6 of each intervention | Incremental and total area under the Concentration-Time Curve |
| Pulse | The first 24 hours of intervention and at experimental day 6 | Changes in pulse, beats per minute |
| Glucose regulatory hormones | 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 |
| Number of symptomatic hypoglycemic events | An average of 1 week | Self-reported events |
| Incretin hormones | 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 |
Countries
Denmark
Outcome results
None listed