Growth Hormone for Gastroparesis

Recruiting at 1 trial location

Overseen By Tisha Lunsford, MD

Age: 18+

Sex: Any

Trial Phase: Phase < 1

Sponsor: Mayo Clinic

Disqualifiers: Diabetes, Obesity, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 5

Duration: 14 weeks

10 Participants Needed

What You Need to Know Before You Apply

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.

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. ^{1 2 3 4 5}

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. ^{6 7 8 9 10}

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. ^{8 11 12 13 14}

Who Is on the Research Team?

Tisha Lunsford

Principal Investigator

Mayo Clinic

Are You a Good Fit for This Trial?

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.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Growth Hormone

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.

How Is the Trial Designed?

Group I: Treatment Group Experimental Treatment 1 Intervention

Patients with Gastroparesis

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+

Published Research Related to This Trial

Recombinant human growth hormone (GH) is beneficial not only for children with growth hormone deficiency but also for conditions like Turner syndrome, chronic renal failure, and HIV wasting syndrome, indicating its broad therapeutic potential.

While GH shows promise in various populations, including children with idiopathic short stature and the elderly, ongoing long-term monitoring is essential to assess its safety and overall risk-benefit profile.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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

In a study of 16 prepubertal children with growth hormone deficiency treated with a daily subcutaneous dose of 30 micrograms/kg of GHRH for 12 to 24 months, 68.7% showed significant improvement in growth velocity, increasing from a baseline of 3.4 cm/year to around 6.5 cm/year by the end of the treatment.

The treatment was generally safe, with no side effects or adverse changes in glucose and lipid levels observed, and the presence of GHRH antibodies did not appear to affect growth outcomes.

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]

Growth hormone (GH) therapy has significantly improved height outcomes in children with growth hormone deficiency (GHD), with growth velocity increasing from 3-4 cm/year before treatment to 10-12 cm/year during the first two years.

The transition from pituitary-derived GH to recombinant GH was accelerated due to safety concerns, and while higher doses (0.33 mg/kg/week) can enhance height outcomes, they come at a high cost and require careful monitoring for effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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

Growth hormone (GH) therapy is clearly indicated for children with GH deficiency and short girls with Turner syndrome, supported by substantial data.

Emerging evidence suggests GH therapy may also benefit short, poorly growing children with various causes of growth failure, as well as improve clinical status in both GH-deficient and GH-sufficient older adults.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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

Long-term growth hormone (GH) therapy significantly increases height standard deviation scores (HSDS) in pediatric patients with growth hormone deficiency (GHD), Turner syndrome (TS), Noonan syndrome (NS), and Prader-Willi syndrome (PWS), with the most substantial gains observed in the first year of treatment.

Younger age at initiation of GH therapy and lower baseline HSDS are associated with better growth outcomes, while higher GH doses further enhance growth in patients with GHD and TS.

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]

Growth hormone (GH) has been effectively used for over 40 years to improve height velocity in children with growth impairments and to correct metabolic issues related to GH deficiency, supported by extensive efficacy and safety data.

While GH has a wide safety margin, it can cause side effects such as pseudotumor cerebri and hyperglycemia, necessitating careful monitoring, especially in patients with higher risks for adverse events.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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

Recombinant growth hormone (GH) has been safely used since 1985, with a strong safety profile and few adverse events reported, making it a viable treatment for various growth-related conditions.

The FDA has approved GH for multiple indications, including idiopathic short stature (ISS), and there is potential for future uses in conditions like Russell-Silver syndrome and even in areas like wound healing, although more research is needed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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

A comprehensive review of safety data from growth hormone (GH) registries found no increased risk of mortality or stroke in children or adults treated with GH, providing reassurance about its long-term safety.

While there may be a heightened risk of type 2 diabetes in GH-treated patients, this risk is primarily associated with pre-existing conditions, and patients with risk factors for malignancy should be monitored closely during treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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

Growth hormone secretagogues (GHSs), like ibutamoren mesylate, promote the natural release of growth hormone in a way that helps prevent excessively high levels, potentially reducing the risks associated with exogenous growth hormone use.

GHSs have shown promise in improving growth velocity in children, increasing lean mass in individuals with wasting conditions or obesity, and enhancing sleep, but there are concerns about their long-term safety, particularly regarding insulin sensitivity and blood glucose levels.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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

Growth hormone treatment has evolved since the 1950s from being used only for severe growth hormone deficiency to being prescribed for various conditions associated with short stature, affecting hundreds of thousands of children.

There are significant long-term safety concerns regarding growth hormone treatment, particularly related to mortality, cardiovascular issues, and cancer, highlighting the need for ongoing monitoring and research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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

GHRH (Growth Hormone-Releasing Hormone) has been synthesized and is being studied for treating growth hormone deficiencies caused by hypothalamic dysfunction, showing promise in increasing growth velocities in many patients.

However, responses to GHRH treatment vary significantly among individuals, with no clear criteria established to predict who will benefit, indicating the need for further research to optimize dosage and administration methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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

Growth hormone-releasing hormone (GHRH) effectively stimulates growth hormone (GH) release, particularly in GH-deficient patients, indicating its potential as a treatment for growth deficiencies.

Subcutaneous administration of GHRH has been shown to promote growth in about 50% of GH-deficient children, suggesting that depot preparations of GHRH could be a practical alternative for managing GH deficiency.

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]

Growth-hormone-releasing hormone (GHRH) is crucial for stimulating the release of growth hormone (GH) from the pituitary gland and is important for diagnosing and treating GH deficiencies.

Current experimental use of GHRH shows promise in treating GH-deficient children by promoting natural GH secretion, which may help accelerate their growth.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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

GHRH, a newly synthesized growth hormone-releasing hormone, effectively stimulates growth hormone secretion and can help differentiate between hypothalamic and pituitary causes of growth hormone deficiency in patients.

Preliminary findings indicate that GHRH may promote linear growth in some children with growth hormone deficiency, suggesting it could be a promising alternative therapy, especially if delivered through depot preparations or intranasal methods.

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]

Citations

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]