Testing the effects of lixisenatide on pituitary hormones
The Effect of Lixisenatide on the Effect of Pituitary Hormones
This study is testing if a single dose of lixisenatide can help measure growth hormone levels in healthy people and those with type 1 diabetes, while also looking at how blood sugar changes might affect the results.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 10 (estimated) |
| Ages | 18 Years to 60 Years |
| Sex | Male |
| Sponsor | University of Tartu Academic / other |
| Locations | 1 site (Tartu) |
| Trial ID | NCT05804513 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate whether a single dose of lixisenatide can serve as a growth hormone stimulation test and to determine if its effects are influenced by changes in blood glucose levels. The study involves a randomized, blinded, placebo-controlled design with 5 healthy volunteers and 5 patients with type 1 diabetes. Participants will receive both a placebo and lixisenatide, with blood samples collected at various intervals to measure growth hormone levels and other physiological parameters. The primary endpoint is the peak growth hormone value measured within 2.5 hours post-administration.
Who should consider this trial
Good fit: Ideal candidates include healthy male volunteers and male patients aged 18-60 with type 1 diabetes who meet specific health criteria.
Not a fit: Patients who are using medications that significantly affect pituitary function or have unstable blood glucose levels may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new method for assessing growth hormone function in patients with diabetes.
How similar studies have performed: While similar approaches have been explored, this specific application of lixisenatide as a growth hormone stimulation test is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Healthy volunteers: * male sex * age 18-60 years * body weight \> 65 kg 2. Patients with type 1 diabetes: * type 1 diabetes * male sex * age 18-60 years * body weight \> 65 kg * c-peptide in fasting blood sample \<0,1 nmol/l * HbA1c \< 8,5% Exclusion Criteria: 1. Healthy volunteers: * use of aldosterone antagonist * use of glucocorticosteroid * use of other medication that potentially significantly affects pituitary function. 2. Patients with type 1 diabetes: * use of aldosterone antagonist * use of glucocorticosteroid * use of other medication that potentially significantly affects pituitary function. * The patient is excluded from the study if a significant change in blood glucose occurs in the study center.
Where this trial is running
Tartu
- Tartu University Hospital — Tartu, Estonia (Recruiting)
Study contacts
- Principal investigator: Vallo Volke, MD, PhD — University of Tartu, Tartu University Hosptial
- Study coordinator: Vallo Volke, MD, PhD
- Email: vallo.volke@ut.ee
- Phone: 7374330
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.