Using Growth Hormone to Treat Gastroparesis
Low-dose Growth Hormone for the Treatment of Gastroparesis
This study is testing if Growth Hormone can help people with gastroparesis feel better when other treatments haven't worked.
Quick facts
| Phase | Early Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 10 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Mayo Clinic Academic / other |
| Locations | 2 sites (Phoenix, Arizona and 1 other locations) |
| Trial ID | NCT06803589 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the effectiveness of Growth Hormone in alleviating symptoms in patients suffering from gastroparesis, a condition characterized by delayed gastric emptying. Participants will be selected based on their chronic symptoms that have not improved with standard treatments, and their symptom severity will be assessed using the Gastroparesis Cardinal Symptom Index. The study is designed as an early-phase interventional trial to gather preliminary data on the potential benefits of this treatment approach.
Who should consider this trial
Good fit: Ideal candidates are individuals with gastroparesis symptoms lasting over six months that have not responded to standard treatments.
Not a fit: Patients with a history of growth hormone deficiency, diabetes, or other specified exclusion criteria may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve the quality of life for patients with gastroparesis by alleviating their symptoms.
How similar studies have performed: While this approach is novel, similar studies exploring hormonal treatments for gastrointestinal disorders have shown promise, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Symptoms \> 6 months that have not responded satisfactorily to standard treatment. * For gastroparesis: Gastroparesis Cardinal Symptom Index (GCSI) score of \>21 Exclusion Criteria: * Known history of GH deficiency, hypothalamic or pituitary disease * Diabetes * Prior use of GH therapy * Age-adjusted low serum IGF1 * Women on oral estrogen therapy6 * Pregnancy or nursing * History of malignant solid tumors * Obesity (BMI \> 30)History of coronary and thromboembolic diseases. * History of sarcoidosis * History of pituitary surgery * History of thyroid nodules. * Any other condition, which in the opinion of the investigator would impede compliance or hinder completion of the study. * Failure to give informed consent.
Where this trial is running
Phoenix, Arizona and 1 other locations
- Mayo Clinic — Phoenix, Arizona, United States (Recruiting)
- Mayo Clinic in Arizona — Scottsdale, Arizona, United States (Recruiting)
Study contacts
- Principal investigator: Tisha Lunsford — Mayo Clinic
- Study coordinator: Guillermo GI Program Coordinator, Research
- Email: barahona.guillermo@mayo.edu
- Phone: 480-301-4679
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.