Diet Management for Acromegaly

Overseen By Daniel Gomez

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Cedars-Sinai Medical Center

Disqualifiers: Diet restrictions

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

Compensation: Varies

Number of Visits: Unknown

9 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how different diets might help people with acromegaly, a condition where the body produces too much growth hormone, leading to enlarged features and other health issues. Researchers aim to determine if a low-carbohydrate or low-gluten diet can slow symptom progression and improve treatment outcomes. Participants will either follow one of these diets or maintain their usual eating habits. People diagnosed with acromegaly who do not have specific diet restrictions might be a good fit for this study. As an unphased trial, this study offers a unique opportunity to contribute to understanding dietary impacts on acromegaly.

Do I need to stop my current medications for this trial?

The protocol does not specify if you need to stop your current medications.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that both low gluten and low carbohydrate diets are generally safe. Many individuals have followed these diets for health reasons without major issues.

For the low gluten diet, studies have not reported specific problems related to acromegaly. Many people follow gluten-free diets for conditions like celiac disease and do well.

Regarding the low carbohydrate diet, research indicates it can help manage certain health conditions, including acromegaly. However, maintaining a balanced diet is important to avoid side effects like tiredness or nutrient deficiencies. Some studies mention changes in how the body handles sugar, so monitoring blood sugar levels might be important for those on this diet.

Overall, both diets are considered safe for this trial. However, consulting a healthcare provider before making significant dietary changes is always wise, especially for those with medical conditions. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores dietary management as a way to manage acromegaly, a condition typically treated with surgery, medication, or radiation therapy. Unlike these standard treatments, which focus on reducing growth hormone levels, this study examines whether specific diets can impact symptoms by modifying daily nutrition. The unique aspects include investigating low gluten and low carbohydrate diets to see how they might reduce symptoms or improve quality of life for those affected by acromegaly. This dietary approach could offer a less invasive and more holistic method of managing the condition, potentially reducing the need for more aggressive interventions.

What evidence suggests that this trial's treatments could be effective for acromegaly?

This trial will compare different dietary approaches for managing acromegaly. Participants may be assigned to a low-gluten diet, which research suggests might reduce inflammation and ease symptoms. Another group will follow a low-carbohydrate diet, which some studies indicate could improve sugar metabolism, a common issue in acromegaly. Although data remains limited, these diets are believed to help manage the condition by addressing some of its complications. Early results appear promising, but more evidence is needed to confirm these effects. ^{1 2 5 6 7}

Are You a Good Fit for This Trial?

This trial is for individuals who have been diagnosed with acromegaly, a condition often caused by a pituitary gland tumor resulting in excess growth hormone. Participants should not have any existing dietary restrictions that would prevent them from following the specific diet plans used in this study.

Inclusion Criteria

I have been diagnosed with acromegaly.

Exclusion Criteria

Diet restrictions.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dietary Intervention

Participants receive counseling, education, and implementation of either a low carbohydrate or low gluten diet

8 weeks

Follow-up

Participants are monitored for changes in growth hormone levels, insulin-like growth factor 1, and acromegaly related symptoms

8 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Diet

Trial Overview The study is examining how a low carbohydrate and low gluten diet might affect the progression of acromegaly, as well as its symptoms, complications, and how well other treatments work. The goal is to see if these diets can play a role in managing the condition.

How Is the Trial Designed?

Group I: Low gluten Active Control 1 Intervention

Counseling, education, and implementation of low gluten diet.

Group II: Standard Active Control 1 Intervention

No change/intervention in diet. Continuation of standard diet.

Group III: Carbohydrate Active Control 1 Intervention

Counseling, education, and implementation of low carbohydrate diet.

Who Is Running the Clinical Trial?

Cedars-Sinai Medical Center

Lead Sponsor

Trials

523

Recruited

165,000+

Published Research Related to This Trial

In a study of 30 patients with newly diagnosed acromegaly, 24 weeks of lanreotide Autogel therapy significantly reduced growth hormone (GH) and IGF-1 levels, leading to tumor shrinkage in nearly all patients, indicating effective management of the disease.

While improvements in cardiac and vascular health were observed, such as reduced arterial stiffness and changes in left ventricular mass in men, the responses varied widely among individuals, suggesting that lowering GH and IGF-1 does not guarantee uniform improvement in all complications associated with acromegaly.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A comprehensive study of clinical, biochemical, radiological, vascular, cardiac, and sleep parameters in an unselected cohort of patients with acromegaly undergoing presurgical somatostatin receptor ligand therapy. Annamalai, AK., Webb, A., Kandasamy, N., et al.[2022]

New drug formulations and therapies for acromegaly, including longer-acting somatostatin analogs and combination therapies, are being developed to help the approximately 25% of patients who do not respond well to current treatments.

Pasireotide, a multi-receptor ligand, and temozolomide for aggressive pituitary tumors show promise in clinical trials, potentially improving disease control for patients inadequately managed by existing therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Investigational therapies for acromegaly. Grasso, LF., Pivonello, R., Colao, A.[2018]

Transsphenoidal surgery (TSS) is the most effective initial treatment for acromegaly, achieving biochemical control in 80-90% of patients with microadenomas and 50-60% with macroadenomas, but its success depends on tumor size and surgeon expertise.

Somatostatin analogues, particularly long-acting octreotide, are the most effective medical therapy for acromegaly, normalizing IGF-I levels in about 66% of patients and leading to tumor shrinkage in approximately 30% of cases, although gastrointestinal side effects are common.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

How effective are current therapies for acromegaly? Freda, PU.[2019]

Feeding weanling female rats a restricted amount of the LAD 2 diet or the RDM 22 maintenance diet resulted in significantly better survival rates (62% and 66%, respectively) compared to those fed the LAD 2 diet ad libitum, which had a survival rate of only 40%.

The groups on restricted diets (LAD 2 and RDM 22) exhibited fewer pathological lesions and pituitary tumors, indicating a potential link between diet restriction and improved health outcomes, despite the restricted groups weighing less than those on ad libitum diets.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of diet on the incidence of pituitary tumours in female Wistar rats. Pickering, RG., Pickering, CE.[2017]

In a study involving endoscopic screening for colorectal polyps, higher dietary fiber intake was associated with a reduced risk of increased adenoma volume in men, suggesting a protective effect against polyp growth.

Conversely, there was an inconsistent trend indicating that higher total fat intake may be linked to increased adenoma mass, highlighting the complex relationship between diet and colorectal health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Colorectal adenomas and food. A prospective study of change in volume and total mass of adenomas in man. Hoff, G., Moen, IE., Trygg, K., et al.[2019]

In a study of 139 patients who underwent transphenoidal surgery for acromegaly, 67% achieved remission defined as mean growth hormone levels below 5 mU/l, with higher success rates observed in patients with smaller tumors (91% for microadenomas vs. 46% for macroadenomas).

The success rates for surgery improved over time, with a notable increase from 48% to 74% in the last five years analyzed, indicating that surgical experience plays a crucial role in achieving better outcomes for patients with acromegaly.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Outcome of transphenoidal surgery for acromegaly and its relationship to surgical experience. Ahmed, S., Elsheikh, M., Stratton, IM., et al.[2019]

In a study of 75 acromegalic patients, it was found that excess growth hormone (GH) and insulin-like growth factor I (IGF-I) are associated with increased lean mass and decreased fat mass, indicating significant changes in body composition.

The anabolic effects of GH on bone mineral density (BMD) are influenced by these body composition changes, as positive correlations were observed between GH levels and BMD at the lumbar spine, suggesting that managing body composition may be important for bone health in acromegaly.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of GH-IGF-I excess and gonadal status on bone mineral density and body composition in patients with acromegaly. Madeira, M., Neto, LV., de Lima, GA., et al.[2021]

In a study of 89 acromegalic patients treated with surgery and/or radiotherapy, only 39% achieved a biochemical 'cure' defined as a growth hormone (GH) level of less than 5 mU/l, indicating that treatment outcomes may need improvement.

The likelihood of achieving a biochemical cure was more closely related to pretreatment GH levels rather than tumor size, suggesting that monitoring GH levels could be a key factor in assessing treatment effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Birmingham pituitary database: auditing the outcome of the treatment of acromegaly. Jenkins, D., O'Brien, I., Johnson, A., et al.[2019]

In a 4-month study involving 16 patients with active acromegaly, treatment with pioglitazone did not result in any significant changes in serum IGF-1 levels, indicating it may not be effective for this condition.

Additionally, there were no significant changes in growth hormone levels after glucose loading during pioglitazone therapy, suggesting that this medication does not improve biochemical markers of acromegaly.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pioglitazone in acromegaly - an open-label, prospective study. Kim, DD., Goh, J., Panossian, Z., et al.[2018]

In a study involving 76 male F344 rats, dietary miso was found to significantly inhibit the development of aberrant crypt foci (ACF), a precursor to colon cancer, in a dose-dependent manner, with the highest dose (20% miso) showing the most significant reduction.

While NaCl supplementation showed some association with fewer ACF, the results were not statistically significant, highlighting that miso may be a more effective dietary intervention for preventing colon carcinogenesis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of miso and NaCl on the development of colonic aberrant crypt foci induced by azoxymethane in F344 rats. Masaoka, Y., Watanabe, H., Katoh, O., et al.[2015]

In a study involving Fischer 344 and Holtzman rats, dietary energy intake was found to significantly influence the development of pituitary tumors induced by the synthetic estrogen diethylstilbestrol (DES), with energy restriction leading to a reduced tumor response in Fischer 344 rats.

The results suggest that while energy consumption affects tumor development, it does so after the initial cell proliferation induced by DES, indicating a potential mechanism by which diet may modulate estrogen-related tumorigenesis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Estrogen induction of prolactin-producing pituitary tumors in the Fischer 344 rat: modulation by dietary-energy but not protein consumption. Shull, JD., Birt, DF., McComb, RD., et al.[2013]

Dietary restriction in male F344 rats helps maintain the renewal rate of somatotropes in the pituitary gland as they age, suggesting a protective effect against age-related decline.

The study found that while the overall rate of somatotrope renewal did not change with diet or age, dietary restriction preserved a higher fraction of these growth hormone-producing cells in older rats, indicating potential benefits for growth hormone secretion during aging.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dietary restriction maintains the basal rate of somatotrope renewal in later life in male rats. Shimokawa, I., Tomita, M., Higami, Y., et al.[2021]

Improved surgical techniques and innovative medical therapies can significantly enhance clinical outcomes for patients with acromegaly.

Primary medical therapy, used in patients who have not had surgery or radiotherapy, can lead to near normalization of growth hormone (GH) and insulin-like growth factor 1 (IGF-I) levels, along with substantial tumor shrinkage in many cases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Primary medical therapy for acromegaly. Sheppard, MC.[2021]

In a study of 438 acromegalic patients, the overall mortality rate was found to be lower than that of the general population, indicating that therapies for acromegaly have improved survival rates.

Patients receiving somatostatin analogue (SSA) therapy as the primary treatment had a significantly higher risk of death compared to those who underwent adenomectomy, especially in diabetic patients, suggesting that SSA therapy may be less effective in this group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of the effects of primary somatostatin analogue therapy and pituitary adenomectomy on survival in patients with acromegaly: a retrospective cohort study. Bogazzi, F., Colao, A., Rossi, G., et al.[2022]

In a study of 163 patients with acromegaly, 96.2% of those treated with medical therapy achieved biochemical control, indicating that medical treatment is highly effective for managing the condition after pituitary surgery.

Among the 53 patients receiving medical therapy, a variety of treatment combinations were used, with first-generation somatostatin receptor ligands being the most common, demonstrating the flexibility in treatment options available for acromegaly.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Medical treatment of acromegaly-experience from the Croatian acromegaly registry. Solak, M., Kraljević, I., Popovac, H., et al.[2023]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10041756/

Caloric restriction as a possible pitfall for persistent ... This clinical report shows that caloric restriction may represent a pitfall in acromegaly follow-up.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05401084

NCT05401084 | Diet in the Management of Acromegaly Impact of low carbohydrate and low gluten diet on acromegaly progression, symptoms, complications, and treatment outcomes.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8325668/

Glucose metabolism outcomes in acromegaly patients on ... Overall, glucose metabolism improved in 3 (all in PAS-LAR + Peg-V; 7.5%), worsened in 26 (65%) and remained unchanged in 11 patients (27.5%). Glucose metabolism ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT06949891

KETOgenic Diet Therapy in Patients With ACROmegaly A eucaloric ketogenic diet (30-40 g carbohydrate per day) for 3 months, followed by a less strict ketogenic diet (50-60 g carbohydrate per day) for another 3 ...

5. withpower.com withpower.com/trial/phase-acromegaly-5-2022-b064c

Diet Management for Acromegaly What is the purpose of this trial? Impact of low carbohydrate and low gluten diet on acromegaly progression, symptoms, complications, and treatment outcomes.

6. endocrine-abstracts.org endocrine-abstracts.org/ea/0070/ea0070aep670

Eucaloric very low-carbohydrate ketogenic diet as a new ... Our results could affect the clinical management of acromegaly as a euVLCK diet might deploy as an effective adjuvant treatment in some ...

7. trialfinder.panfoundation.org trialfinder.panfoundation.org/en-US/trial/listing/602815

KETOgenic Diet Therapy in Patients With ACROmegaly A eucaloric ketogenic diet (30-40 g carbohydrate per day) for 3 months, followed by a less strict ketogenic diet (50-60 g carbohydrate per day) ...