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?

This trial tests whether Growth Hormone can alleviate symptoms in people with gastroparesis. Gastroparesis prevents the stomach from emptying food properly, leading to nausea, vomiting, and bloating. The trial aims to determine if Growth Hormone can ease these symptoms in individuals whose condition hasn't improved with standard treatments. It seeks participants who have experienced symptoms for over six months. As an Early Phase 1 trial, this research focuses on understanding how Growth Hormone works in people, offering participants the opportunity to be among the first to receive this treatment.

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 there any evidence suggesting that this treatment is likely to be safe for humans?

Research has shown that growth hormone has been used safely for over 40 years, with a large safety margin. Only a few unwanted side effects have been reported, indicating it is generally well-tolerated. However, since this is an early phase trial, the researchers are still studying the safety of growth hormone for treating gastroparesis. Participants in this study will contribute to understanding how the treatment affects individuals with gastroparesis. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike most treatments for gastroparesis, which often focus on symptom management using medications like antiemetics, prokinetics, or dietary changes, the use of growth hormone offers a unique approach. Growth hormone is thought to target the underlying motility issues by potentially enhancing the strength and coordination of stomach contractions. Researchers are excited about this treatment because it could address the root cause of gastroparesis rather than just alleviating symptoms, offering a new hope for more effective management of this challenging condition.

What evidence suggests that Growth Hormone might be an effective treatment for gastroparesis?

Research has shown that growth hormone might aid gastroparesis by improving stomach emptying. In one study, ghrelin, a hormone similar to growth hormone, helped diabetic mice with gastroparesis empty their stomachs faster. This finding suggests that growth hormone could have a similar effect. Although direct evidence on growth hormone's effects on gastroparesis in humans is limited, it appears promising for enhancing stomach function. Growth hormone may help the stomach move food more effectively, potentially reducing symptoms like nausea and bloating. Participants in this trial will receive growth hormone to evaluate its potential benefits for gastroparesis. ^{3 4 6 7 8}

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

Failure to give informed consent

I have had thyroid nodules.

Any other condition, which in the opinion of the investigator would impede compliance or hinder completion of the study

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 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]

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 (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]

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]

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-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]

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]

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-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]

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]

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]

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 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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7492501/

Efficacy and Safety of Ghrelin Agonists in Patients with ... RESULTS · 3. Overall gastroparesis symptoms. Our meta-analysis confirmed a significantly better performance by ghrelin agonists (vs placebo) regarding change in ...

2. cureus.com cureus.com/articles/204064-relamorelin-in-gastroparesis-and-diabetic-gastroparesis-a-meta-analysis-on-its-efficacy-and-safety

Relamorelin in Gastroparesis and Diabetic ... Relamorelin demonstrated a statistically significant improvement in gastric emptying time with a mean difference of -11.40 minutes compared to ...

3. withpower.com withpower.com/trial/growth-hormone-for-gastroparesis-35987

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

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0024320514005347

Preclinical gastrointestinal prokinetic efficacy and ... RM-131's potency, efficacy and endocrine profile, are promising attributes for the treatment of diverse functional gastrointestinal disorders in humans.

5. wjgnet.com wjgnet.com/1007-9327/full/v14/i9/1419.htm

Gastric motor effects of ghrelin and growth hormone ... CONCLUSION: Ghrelin and GHRP-6 increase gastric emptying in diabetic mice with gastroparesis, perhaps by activating peripheral cholinergic ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7318559/

Overall safety of relamorelin in adults with diabetic gastroparesis In summary, these data demonstrate the favourable safety and tolerability profile of relamorelin 10‐100 µg in adults with diabetic ...

7. gutnliver.org gutnliver.org/journal/view.html?uid=1627&vmd=Full&bodyNum=04

Efficacy and Safety of Ghrelin Agonists in Patients with ... In conclusion, ghrelin agonists effectively improve symptoms related to gastroparesis in patients with DG, more so than placebo. Despite concerns over blood ...

8. gastrojournal.org gastrojournal.org/article/s0016-5085(17)35966-8/fulltext

Efficacy and Safety of Relamorelin in Diabetics With ... Relamorelin significantly reduced core symptoms of gastroparesis symptoms and overall composite symptom scores compared to placebo, accelerated gastric emptying ...