NCT06137586Completed
The Effect of Glucose-dependent Insulinotropic Polypeptide on the Alpha Cell Response to Hypoglycaemia in Patients with Type 1 Diabetes
Source: ClinicalTrials.gov · Last updated 10 Dec 2024
Brief summary (registry, in English)
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 diabetes. The main question it aims to answer is: • What dose and isoform of GIP can most potently stimulate glucagon secretion during low blood sugar in patients with type 1 diabetes? Participants will go through 5 experimental days that are identical except for an intravenous infusion of either placebo (saline), high or low dose GIP\[1-42\] or high or low dose GIP\[1-30\]. On all days, blood sugar will be lowered to around 2.5mmol/l for around 20-30min.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 10 (actual)
- First submitted
- 9 Nov 2023
- Start date
- 10 Aug 2022
- Primary completion date
- 17 May 2024
- Lead sponsor
- University Hospital, Gentofte, Copenhagen
- Diseases
- Type 1 diabetes
- NCT number
- NCT06137586
What you commit to
- Study type: Interventional
- Participants enrolled: 10
- From 10 Aug 2022 to the primary completion date, 17 May 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior myocardial infarction or other cardiac events
Other illness
- Liver disease (ALAT and/or ASAT \>2 times normal values) or history of hepatobiliary disorder
- Allergy or intolerance to ingredients included in the standardized meals
- Any physical or psychological condition that the investigator feels would interfere with trial participation
Lab values
- Anaemia (haemoglobin below normal range)
- Treatment with any glucose-lowering drugs beside insulin
Other
- Late microvascular complications except mild nonproliferative retinopathy
Who the study is looking for
- 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
Age in the registry: 18 years to 70 years · Sex: Male · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Center for Clinical Metabolic Research, Gentofte Hospital Coordinator of this site? Confirm its status | Hellerup | Denmark | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.