Growth Hormone for Gastroparesis

Recruiting in Palo Alto (17 mi)

+1 other location

Overseen by Tisha Lunsford

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase < 1

Recruiting

Sponsor: Mayo Clinic

Disqualifiers: Diabetes, Obesity, Pregnancy, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

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

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team to understand any specific requirements.

What data supports the effectiveness of the drug Growth Hormone for treating gastroparesis?

While there is no direct evidence for using Growth Hormone to treat gastroparesis, it has been shown to be beneficial in other conditions like growth hormone deficiency, Turner syndrome, and HIV wasting syndrome, suggesting it may have potential in other areas. ^{1 2 3 4 5}

Is growth hormone generally safe for humans?

Growth hormone has been used for over 40 years and is considered to have a wide safety margin, with few adverse events reported. Some side effects like swelling, increased blood sugar, and bone issues require monitoring, but there is no evidence it increases cancer risk. Long-term safety is still being studied, especially regarding mortality and stroke risk. ^{6 7 8 9 10}

How does the drug Growth Hormone differ from other treatments for gastroparesis?

Growth Hormone is unique for gastroparesis as it is primarily used to stimulate growth hormone release, which is different from typical treatments that focus on managing symptoms like nausea and delayed stomach emptying. This approach may offer a novel way to address underlying issues rather than just symptoms. ^{2 11 12 13 14}

Research Team

Tisha Lunsford

Principal Investigator

Mayo Clinic

Eligibility Criteria

This trial is for individuals with gastroparesis, a condition that affects stomach emptying, who haven't improved after standard treatments. Participants must have had symptoms for over 6 months and score above 21 on the Gastroparesis Cardinal Symptom Index. Exclusions include thyroid issues, heart diseases, obesity, pregnancy, certain hormonal therapies or conditions, and past growth hormone therapy.

Inclusion Criteria

My symptoms have lasted over 6 months without improvement from standard treatments.

My stomach empties slowly, causing severe symptoms.

Exclusion Criteria

I have had thyroid nodules.

Failure to give informed consent

I have a history of heart and blood clot issues.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Growth Hormone treatment to assess symptomatic improvement in gastroparesis

14 weeks

5 visits (in-person) at Baseline, 4 weeks, 8 weeks, 12 weeks, 14 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Growth Hormone (Hormone Therapy)

Trial Overview The study is testing whether Growth Hormone can help relieve symptoms in patients with gastroparesis. It aims to see if those treated with Growth Hormone feel better compared to their condition before the treatment.

Participant Groups

Group I: Treatment Group Experimental Treatment 1 Intervention

Patients with Gastroparesis

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Mayo Clinic Phoenix, AZ

Mayo Clinic in Arizona Scottsdale, AZ

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3427

Patients Recruited

3,221,000+

Findings from Research

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Recombinant human growth hormone: old and novel uses. Tritos, NA., Mantzoros, CS.[2019]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term therapy with a single daily subcutaneous dose of growth hormone releasing hormone (1-29) in prepubertal growth hormone deficient children. Venezuelan Collaborative Study Group. Lanes, R., Carrillo, E.[2019]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Growth hormone therapy. Bajpai, A., Menon, PS.[2023]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical actions of growth hormone. Wilson, DM.[2004]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Factors Associated With Response to Growth Hormone in Pediatric Growth Disorders: Results of a 5-year Registry Analysis. Ross, J., Fridman, M., Kelepouris, N., et al.[2023]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and efficacy of growth hormone therapy in childhood. Bowlby, DA., Rapaport, R.[2008]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Emerging options in growth hormone therapy: an update. Kemp, SF., Frindik, JP.[2023]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term safety of growth hormone-A combined registry analysis. Stochholm, K., Kiess, W.[2019]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Safety and Efficacy of Growth Hormone Secretagogues. Sigalos, JT., Pastuszak, AW.[2019]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The history, physiology and treatment safety of growth hormone. Tidblad, A.[2022]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Treatment of growth hormone deficiencies by GHRH]. Rochiccioli, P., Tauber, M.[2006]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Growth hormone-releasing hormone: studies in normal subjects and patients with disorders of growth hormone secretion. Ross, RJ., Grossman, A.[2018]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Growth-hormone-releasing hormone. Vance, ML.[2019]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Growth hormone-releasing hormone in the diagnosis and treatment of growth hormone deficient children. Ross, RJ., Grossman, A., Besser, GM., et al.[2019]

References

1. United States pubmed.ncbi.nlm.nih.gov

Recombinant human growth hormone: old and novel uses. [2019]

2. England pubmed.ncbi.nlm.nih.gov

Long-term therapy with a single daily subcutaneous dose of growth hormone releasing hormone (1-29) in prepubertal growth hormone deficient children. Venezuelan Collaborative Study Group. [2019]

3. India pubmed.ncbi.nlm.nih.gov

Growth hormone therapy. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

Clinical actions of growth hormone. [2004]

5. United States pubmed.ncbi.nlm.nih.gov

Factors Associated With Response to Growth Hormone in Pediatric Growth Disorders: Results of a 5-year Registry Analysis. [2023]

6. Israel pubmed.ncbi.nlm.nih.gov

Safety and efficacy of growth hormone therapy in childhood. [2008]

7. New Zealand pubmed.ncbi.nlm.nih.gov

Emerging options in growth hormone therapy: an update. [2023]

8. England pubmed.ncbi.nlm.nih.gov

Long-term safety of growth hormone-A combined registry analysis. [2019]

9. Netherlands pubmed.ncbi.nlm.nih.gov

The Safety and Efficacy of Growth Hormone Secretagogues. [2019]

10. Norway pubmed.ncbi.nlm.nih.gov

The history, physiology and treatment safety of growth hormone. [2022]

11. France pubmed.ncbi.nlm.nih.gov

[Treatment of growth hormone deficiencies by GHRH]. [2006]

12. Switzerland pubmed.ncbi.nlm.nih.gov

Growth hormone-releasing hormone: studies in normal subjects and patients with disorders of growth hormone secretion. [2018]

13. England pubmed.ncbi.nlm.nih.gov

Growth-hormone-releasing hormone. [2019]

14. Denmark pubmed.ncbi.nlm.nih.gov

Growth hormone-releasing hormone in the diagnosis and treatment of growth hormone deficient children. [2019]