Growth Hormone for the Treatment of Gastroparesis

Mayo Clinic

Status and phase: Enrolling; Early Phase 1

Conditions: Gastroparesis

Treatments: Drug: Growth Hormone

Study type: Interventional

Funder types: Other

Identifiers

NCT06803589

24-003183

Details and patient eligibility

About

The purpose of this study is to determine whether treatment with Growth Hormone results in symptomatic improvement in patients with gastroparesis.

Enrollment: 10 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

Treatment Group

Experimental group

Description:

Patients with Gastroparesis

Treatment:

Drug: Growth Hormone