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

Trial Summary

What is the purpose of this trial?

Impact of low carbohydrate and low gluten diet on acromegaly progression, symptoms, complications, and treatment outcomes.

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

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

What data supports the idea that Diet Management for Acromegaly is an effective treatment?

The available research does not provide specific data supporting the effectiveness of Diet Management for Acromegaly. Instead, it focuses on surgical and medical treatments, such as transphenoidal surgery and primary medical therapy, which have shown improvements in patient outcomes. For example, medical therapy has been noted to significantly improve clinical outcomes and reduce tumor size. Therefore, there is no direct evidence from the provided research that supports Diet Management as an effective treatment for acromegaly. ^{1 2 3 4 5}

What safety data exists for diet management in acromegaly treatment?

The research primarily involves animal studies, particularly in rats, examining the effects of different diets on pituitary tumors and other health markers. Dietary restriction and specific diets have shown varying impacts on tumor development and survival rates. For instance, dietary restriction maintained somatotrope renewal in male rats, and energy restriction inhibited estrogen-induced pituitary tumor development in F344 rats. However, these studies do not directly address safety data for diet management in acromegaly treatment in humans, and further research would be needed to establish safety and efficacy in this context. ^{6 7 8 9 10}

Is the treatment Diet a promising treatment for acromegaly?

The information provided does not mention Diet as a treatment for acromegaly, so we cannot say if it is promising. Current treatments focus on surgery, drugs, and radiotherapy to manage hormone levels and tumor growth. ^{11 12 13 14 15}

Eligibility Criteria

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.

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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]

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]

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]

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]

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]

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 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]

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 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]

References

1. England pubmed.ncbi.nlm.nih.gov

Outcome of transphenoidal surgery for acromegaly and its relationship to surgical experience. [2019]

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

The Birmingham pituitary database: auditing the outcome of the treatment of acromegaly. [2019]

3. England pubmed.ncbi.nlm.nih.gov

Primary medical therapy for acromegaly. [2021]

4. England 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. [2022]

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

Medical treatment of acromegaly-experience from the Croatian acromegaly registry. [2023]

6. England pubmed.ncbi.nlm.nih.gov

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

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

Dietary restriction maintains the basal rate of somatotrope renewal in later life in male rats. [2021]

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

Effects of miso and NaCl on the development of colonic aberrant crypt foci induced by azoxymethane in F344 rats. [2015]

9. United States 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. [2013]

10. England pubmed.ncbi.nlm.nih.gov

Colorectal adenomas and food. A prospective study of change in volume and total mass of adenomas in man. [2019]

11. United States 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. [2022]

12. England pubmed.ncbi.nlm.nih.gov

Investigational therapies for acromegaly. [2018]

13. Scotland pubmed.ncbi.nlm.nih.gov

How effective are current therapies for acromegaly? [2019]

14. England 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. [2021]

15. England pubmed.ncbi.nlm.nih.gov

Pioglitazone in acromegaly - an open-label, prospective study. [2018]