Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
EARLY_PHASE1
10 participants
INTERVENTIONAL
2024-10-22
2027-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Treatment Group
Patients with Gastroparesis
Growth Hormone
Subjects will receive growth hormone, Sogroya (Somapacitan-beco injections) via weekly injections for 12 weeks.
For males, the fixed dose will be 0.2 mg/day, 1.5 mg per week
For females, the fixed dose will be 0.3 mg/day, 2.1 mg per week
Interventions
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Growth Hormone
Subjects will receive growth hormone, Sogroya (Somapacitan-beco injections) via weekly injections for 12 weeks.
For males, the fixed dose will be 0.2 mg/day, 1.5 mg per week
For females, the fixed dose will be 0.3 mg/day, 2.1 mg per week
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* For gastroparesis: Gastroparesis Cardinal Symptom Index (GCSI) score of \>21
Exclusion Criteria
* 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.
18 Years
65 Years
ALL
No
Sponsors
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Mayo Clinic
OTHER
Responsible Party
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Tisha N. Lunsford
GI and Hepatology Consultant
Principal Investigators
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Tisha Lunsford
Role: PRINCIPAL_INVESTIGATOR
Mayo Clinic
Locations
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Mayo Clinic
Phoenix, Arizona, United States
Mayo Clinic in Arizona
Scottsdale, Arizona, United States
Countries
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Central Contacts
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Guillermo GI Program Coordinator, Research
Role: CONTACT
Phone: 480-301-4679
Email: [email protected]
Facility Contacts
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Guillermo Barahona Hernandez, Research Coordinator
Role: primary
Guillermo Barahona Hernandez, Program Coordinator, Research, 480-301-4679
Role: primary
Tisha Lunsford, MD
Role: backup
Related Links
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Mayo Clinic Clinical Trials
Other Identifiers
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24-003183
Identifier Type: -
Identifier Source: org_study_id