Status:
COMPLETED
The Effect of Glucose-dependent Insulinotropic Polypeptide on the Alpha Cell Response to Hypoglycaemia in Patients with Type 1 Diabetes
Lead Sponsor:
University Hospital, Gentofte, Copenhagen
Collaborating Sponsors:
The Novo Nordisk Foundation Center for Basic Metabolic Research
Conditions:
Type1diabetes
Hypoglycemia
Eligibility:
MALE
18-70 years
Phase:
NA
Brief Summary
The goal of this clinical trial is to evaluate the effects of the hormone glucose-dependent insulinotropic polypeptide (GIP) and its two isoforms, GIP\[1-30\] and GIP\[1-42\], in patients with type 1 ...
Detailed Description
After being informed about the study and the potential risks, each participant giving written informed consent will participate in five double-blinded experimental days (Day A-E) in a randomized order...
Eligibility Criteria
Inclusion
- Caucasian men
- Body mass index between 18-27kg/m2
- Type 1 diabetes (T1D) (diagnosed according to the criteria of the World Health Organization) with HbA1c\<69 mmol/mol (\<8.5%)
- T1D duration of 2-30 years
- C-peptide negative (stimulated C-peptide ≤ 100 pmol/l)
- Treatment with a stable basal-bolus or insulin pump regimen for ≥3 months
- Informed consent
Exclusion
- Anaemia (haemoglobin below normal range)
- Liver disease (ALAT and/or ASAT \>2 times normal values) or history of hepatobiliary disorder
- Late microvascular complications except mild nonproliferative retinopathy
- 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 feels would interfere with trial participation
- Treatment with any glucose-lowering drugs beside insulin
Key Trial Info
Start Date :
August 10 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 17 2024
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT06137586
Start Date
August 10 2022
End Date
May 17 2024
Last Update
December 10 2024
Active Locations (1)
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1
Center for Clinical Metabolic Research, Gentofte Hospital
Hellerup, Copenhagen, Denmark, 2900