Growth Hormone for the Treatment of Gastroparesis

Early Phase 1

Recruiting

• Conditions: Gastroparesis
• Interventions: Drug: Growth Hormone

• Registration Number: NCT06803589
• Lead Sponsor: Mayo Clinic

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2024-10-22
• Status Verified: 2025-01
• Study First Submitted: 2025-01-27
• Study First Submitted QC: 2025-01-27
• Last Update Submitted: 2025-01-27
• Study First Posted: 2025-01-31
• Last Update Posted: 2025-01-31
• Primary Completion: 2026-10
• Study Completion: 2027-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 10

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment Group	Growth Hormone	Patients with Gastroparesis

Primary Outcome Measures

Name	Time	Method
Gastroparesis Cardinal Symptom Index (GCSI)	Baseline, 4 weeks, 8 weeks, 12 weeks, 14 weeks	The Gastroparesis Cardinal Symptom Index (GCSI) is a questionnaire that assesses the severity of gastroparesis symptoms of: nausea, early satiety, postprandial fullness, and upper abdominal pain. Scores range from 0-none to 4-very severe.

Secondary Outcome Measures

Name	Time	Method
Complete Spontaneous Bowel Movements (CSBMs)	Baseline, 4 weeks, 8 weeks, 12 weeks, 14 weeks	Number of bowel movements, without the aid of laxatives, after which the patient has the sensation of complete defecation.
Gastrointestinal Patient Reported Outcomes Measurement Information System (GI- PROMIS)	Baseline, 4 weeks, 8 weeks, 12 weeks, 14 weeks	The Gastrointestinal Patient Reported Outcomes Measurement Information System (GI-PROMIS) scale assess 8 domains: gastroesophageal reflux, disrupted swallowing, diarrhea, bowel incontinence/soilage, nausea and vomiting, constipation, belly pain, and gas/bloat/flatulence. Scores are scaled so that an average healthy person would score 50 points. A higher score indicates worse gastrointestinal symptoms.

Trial Locations

Locations (2)

Mayo Clinic; 🇺🇸 Phoenix, Arizona, United States

Mayo Clinic in Arizona; 🇺🇸 Scottsdale, Arizona, United States