Gastroparesis
Conditions
Brief summary
The purpose of this study is to determine whether treatment with Growth Hormone results in symptomatic improvement in patients with gastroparesis.
Interventions
DRUGGrowth Hormone
Subjects will receive somapacitan-beco (Sogroya®) administered as a subcutaneous injection once weekly for 12 weeks. All participants will receive a fixed dose of 1.5 mg weekly, regardless of sex.
Sponsors
Mayo Clinic
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Contacts
CONTACTGuillermo GI Program Coordinator, Research
CONTACTTisha Lunsford, MD
PRINCIPAL_INVESTIGATORTisha Lunsford
Mayo Clinic
Outcome results
None listed