2024-510885-17-01CompletedPhase 1
Defining the Glucagon Unit: Investigating the Impact on Energy Expenditure and Glucose Level Deviation in healthy volunteers
Source: EU CTIS (euclinicaltrials.eu) · Last updated 28 Jun 2024
Brief summary (registry, in English)
The primary objective of this study is to define the glucagon unit by investigating its impact on energy expenditure, glucose level deviation in the presence and absence of incretin-stimulated insulin secretion, and comparing the results with intravenous (i/v) and oral (p/o) glucose uptake.
- Status (registry)
- Completed
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 10 (actual)
- First submitted
- 16 Apr 2024
- Start date
- 1 Jun 2025
- Lead sponsor
- Pauls Stradins Clinical University Hospital
- EU CT number
- 2024-510885-17-01
What you commit to
- Study type: Interventional · Phase 1
- Participants enrolled: 10
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study design.
Who cannot take part
Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Current use of any anti-diabetic drugs (for any indication).
- Participants who have received any investigational product or medication within 180 days prior to screening.
- Participants who have donated blood or plasma within 30 days prior to screening.
Other illness
- Diabetes mellitus (any type).
- Any other medical condition or treatment that, in the opinion of the investigator, would interfere with the study objectives, conduct, or interpretation of results.
- Participants who have a known allergy or intolerance to any of the study medications or their components.
- History of gastrointestinal disorders, surgery or other medical conditions that could affect nutrient absorption and/or predispose a subject to side effects of GLP-RA (chronic pancreatitis, dysmotility, rapidly growing thyroid nodules etc)
Lab values
- Abnormal laboratory results: ○ TSH < 0,4 or > 4,0 mIU/L ○ ALAT > 40 U/L ○ CKD (GFR < 90 ml/min/m2) ○ Abnormal fasting glucose (≥6.1 mmol/L) ○ abnormal HbA1c (≥5.7%) ○ Other significant deviations according to research team views
Other
- Not signed informed consent
- Inability to tolerate calorimeter canopy.
- Inability to comply with study requirements
- BMI > 35 kg/m2 and < 25 kg/m2
Who the study is looking for
- Age 18 - 40 years.
- Male sex
- BMI 25 - 34.9.
- Signed informed consent
Age in the registry: 18 years to 64 years · Sex: Male · Accepts healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Pauls Stradins Clinical University Hospital | Riga | Latvia | Completed |
This page is information, not medical advice. Discuss any trial with your doctor.