AcromegalyIpoProAcroNCT05298891
Hypoproteic Diet in Acromegaly
A study testing Usual clinical practice + hypoproteic diet in people with Acromegaly, run by Azienda Ospedaliero Universitaria Maggiore della Carita at 1 site in Italy.
Trial summary
Since protein and AAs are master regulator of GH and IGF-I secretion, we hypothesized that a low protein diet could reduce GH and IGF-I levels in acromegalic patients in addition to conventional therapy. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Acromegaly
- What is being tested?
- Usual clinical practice + hypoproteic diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteItaly
- Study dates
- 1 Dec 2026to 1 Mar 2029
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18/65
- Diagnosis of Acromegaly
- In therapy with somatostatin analogues
Who cannot join
- pregnancy or lactation
- alchool or drugs abuse
- cancer
- Hematological diseases
Trial locations and contacts
1 site in 1 country.
Italy1 site
: Italy Pediatric Endocrine Service of AOU Maggiore della Carità of Novara; SCDU of Pediatrics, Department of Health Sciences, University of Eastern Piedmont
Novara, Italy, 28100
About this study
Official title: Deciphering the Role of a Low Protein Diet in Disease Control in Acromegalic Patients
Since protein and AAs are master regulator of GH and IGF-I secretion, we hypothesized that a low protein diet could reduce GH and IGF-I levels in acromegalic patients in addition to conventional therapy. Furthermore, we aim to explore metabolomic, microbiota, and micro-vesicle fingerprints of GH hypersecretion during conventional therapy and after a low protein diet
Read the detailed description
Nutrients are crucial modifiers of the GH/IGF-I axis. In particular, a close cross-talk between proteins and amino acids (AAs) and GH/IGF-I secretion exists.
Both AAs and proteins affect GH secretion. AAs stimulate GH secretion upon oral administration, with different potency among studies, being the combination of arginine and lysine the most powerful. Soy proteins also stimulate GH secretion when ingested either as hydrolysed proteins or free AAs. Furthermore, the acute GH response to AAs ingestion may be influenced by the daily amount of dietary protein/AAs consumption: diets high in proteins apparently increase basal GH levels.
AAs and proteins have a positive effect on IGF-I secretion as well. In general, high levels of proteins, especially animal and dairy proteins, and consumption of branched chain amino acids (BCAAs) increase serum IGF-I levels.
Considering pathological GH conditions, metabolomic analysis of acromegalic patients suggests that the main metabolic fingerprint of GH hypersecretion is a reduction in BCAAs, related to the disease activity. Moreover, there is evidence that GH, rather than IGF-I, is the main mediator of such metabolic fingerprint, which may be related to increased uptake of BCAAs by the muscles, increased gluconeogenesis, and raised consumption of BCAAs.
Thus, in acromegaly, a tailored diet is a further strategy that may contribute to blunt GH/IGF-I secretion. Indeed, some authors recently suggested that "personalized" or "precision" nutrition in some conditions and diseases could have an impact on their phenotype, combining dietary recommendations with individual's genetic makeup, metabolic and microbiome characteristics, and environment. However, studies on precision nutrition in acromegaly are still in a neonatal era.
- Conditions
- Acromegaly
- Being tested
- Usual clinical practice + hypoproteic diet
- Medical subject headings
- Acromegaly
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Usual clinical practice + hypoproteic dietOther
Diet will be composed by:
- energy equal to daily energy expenditure (estimated by indirect calorimetry * physical activity factor)
- fats 28-35%
- carbohydrates 50-60%
- proteins 0,7-0,8g/kg of body weight 10-13% Diet will be given to the patient after the first visit and the study will start once the patient begins the diet.
| Study group | Role | What they receive |
|---|---|---|
| Acromegalic adult in therapy with somatostatin analogues | Experimental | Patients will continue the usual medical outpatient visits cadency and will keep the same pharmacological therapy throughout the whole duration of the study. Drugs have to include somatostatin analogues. At the same time, patients will be trained by an expert dietician in the habit of an isocaloric and hypoproteic diet and will come back at 2,4,6 and 8 weeks after T0 for all the necessary study assessments and compliance checking. Receives: Other: Usual clinical practice + hypoproteic diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in disease related hormones
Variation of GH, IGF-1, IGFBP1, IGFBP3 hormones
Measured: Change from Baseline GH, IGF-1, IGFBP1, IGFBP3 blood levels at 15 days, 30 days, 45 days, 60 days
Secondary outcomes (16)
Change in weight
Variation of body weight assessed through body mass index change (BMI)(kg/m2)
Measured: Change from Baseline BMI at 15 days, 30 days, 45 days, 60 days
Change in body circumferences
Variation of body circumferences (waist, hips)
Measured: Change from Baseline circumferences at 15 days, 30 days, 45 dyas, 60 days
Change in metabolic control
Change of cardio-metabolic risk factors: lipid profile
Measured: Change from Baseline lipid profile at 15 days, 30 days, 45 days, 60 days
Change in metabolic control
Change of cardio-metabolic risk factors: insulin resistance (HOMA-IR)
Measured: Change from Baseline lipid profile at 60 days
Change in kidney profile
Variation of serum creatinin
Measured: Change from Baseline Serum Creatinin at 15 days, 30 days, 45 days, 60 days
Change in liver profile
Variation of liver markers(AST, ALT, GGT)
Measured: Change from Baseline Serum Creatinin at 15 days, 30 days, 45 days, 60 days
Change in uric acid
Variation of uric acid in blood through enzymatic determination
Measured: Change from Baseline uric acid in blood at 15 days, 30 days, 45 days, 60 days
Change in body composition
Change of body composition (fat mass %) (BIVA)
Measured: Change from Baseline fat mass% at 60 days
Change in body composition
Change of body composition (fat mass %) (DXA)
Measured: Change from Baseline fat mass% at 60 days
Change in blood count
Variation of blood count
Measured: Change from Baseline blood count at 15 days, 30 days, 45 days, 60 days
Change in microbiota
Variation of prevalence of microbiota phyla through DNA sequencing of stools
Measured: Change from Baseline of prevalence of microbiota phyla at 15, 30 days, 45 days, 60 days
Change in omics profile
Variation of lipidomic profile of stools through liquid and gas chromatography
Measured: Change from Baseline omic profile of stools at 15, 30 days, 45 days, 60 days
Change in omics profile
Variation of proteomic profile of stools through liquid and gas chromatography
Measured: Change from Baseline omic profile of stools at 15, 30 days, 45 days, 60 days
Change in microvesicles
Variation of urinary microvesicles levels
Measured: Change from Baseline microvesicles levels at 15, 30 days, 45 days, 60 days
Change in microvesicles
Variation of serum microvesicles levels
Measured: Change from Baseline microvesicles levels s at 15, 30 days, 45 days, 60 days
Change in basal metabolic rate
Variation of basal metabolic rate (kcal)
Measured: Change from Baseline basal metabolic rate at 60 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2022
- Study start1 Dec 2026 (estimated)
- Primary completion1 Dec 2028 (estimated)
- Study completion1 Mar 2029 (estimated)
Why it stopped: ethical issue
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for AcromegalyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Azienda Ospedaliero Universitaria Maggiore della Carita
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Flavia Prodam, Azienda Ospedaliero Universitaria Maggiore della Carita
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05298891
- Sponsor's protocol ID
- CE 008/22
- Acronym
- IpoProAcro
- Status last verified
- Oct 2026
- First submitted
- 18 Mar 2022
- Last updated
- 29 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Caputo M, Pigni S, Agosti E, Daffara T, Ferrero A, Filigheddu N, Prodam F. Regulation of GH and GH Signaling by Nutrients. Cells. 2021 Jun 2;10(6):1376. doi: 10.3390/cells10061376.
PubMed 34199514Suminski RR, Robertson RJ, Goss FL, Arslanian S, Kang J, DaSilva S, Utter AC, Metz KF. Acute effect of amino acid ingestion and resistance exercise on plasma growth hormone concentration in young men. Int J Sport Nutr. 1997 Mar;7(1):48-60. doi: 10.1123/ijsn.7.1.48.
PubMed 9063764van Vught AJ, Nieuwenhuizen AG, Brummer RJ, Westerterp-Plantenga MS. Effects of oral ingestion of amino acids and proteins on the somatotropic axis. J Clin Endocrinol Metab. 2008 Feb;93(2):584-90. doi: 10.1210/jc.2007-1784. Epub 2007 Nov 20.
PubMed 18029456Sellini M, Fierro A, Marchesi L, Manzo G, Giovannini C. [Behavior of basal values and circadian rhythm of ACTH, cortisol, PRL and GH in a high-protein diet]. Boll Soc Ital Biol Sper. 1981 May 15;57(9):963-9. Italian.
PubMed 6269563Levine ME, Suarez JA, Brandhorst S, Balasubramanian P, Cheng CW, Madia F, Fontana L, Mirisola MG, Guevara-Aguirre J, Wan J, Passarino G, Kennedy BK, Wei M, Cohen P, Crimmins EM, Longo VD. Low protein intake is associated with a major reduction in IGF-1, cancer, and overall mortality in the 65 and younger but not older population. Cell Metab. 2014 Mar 4;19(3):407-17. doi: 10.1016/j.cmet.2014.02.006.
PubMed 24606898Allen NE, Appleby PN, Davey GK, Kaaks R, Rinaldi S, Key TJ. The associations of diet with serum insulin-like growth factor I and its main binding proteins in 292 women meat-eaters, vegetarians, and vegans. Cancer Epidemiol Biomarkers Prev. 2002 Nov;11(11):1441-8.
PubMed 12433724Hoppe C, Udam TR, Lauritzen L, Molgaard C, Juul A, Michaelsen KF. Animal protein intake, serum insulin-like growth factor I, and growth in healthy 2.5-y-old Danish children. Am J Clin Nutr. 2004 Aug;80(2):447-52. doi: 10.1093/ajcn/80.2.447.
PubMed 15277169Romo Ventura E, Konigorski S, Rohrmann S, Schneider H, Stalla GK, Pischon T, Linseisen J, Nimptsch K. Association of dietary intake of milk and dairy products with blood concentrations of insulin-like growth factor 1 (IGF-1) in Bavarian adults. Eur J Nutr. 2020 Jun;59(4):1413-1420. doi: 10.1007/s00394-019-01994-7. Epub 2019 May 14.
PubMed 31089868Beasley JM, Gunter MJ, LaCroix AZ, Prentice RL, Neuhouser ML, Tinker LF, Vitolins MZ, Strickler HD. Associations of serum insulin-like growth factor-I and insulin-like growth factor-binding protein 3 levels with biomarker-calibrated protein, dairy product and milk intake in the Women's Health Initiative. Br J Nutr. 2014 Mar 14;111(5):847-53. doi: 10.1017/S000711451300319X. Epub 2013 Oct 7.
PubMed 24094144Li R, Ferreira MP, Cooke MB, La Bounty P, Campbell B, Greenwood M, Willoughby DS, Kreider RB. Co-ingestion of carbohydrate with branched-chain amino acids or L-leucine does not preferentially increase serum IGF-1 and expression of myogenic-related genes in response to a single bout of resistance exercise. Amino Acids. 2015 Jun;47(6):1203-13. doi: 10.1007/s00726-015-1947-8. Epub 2015 Mar 5.
PubMed 25740607Coopmans EC, Berk KAC, El-Sayed N, Neggers SJCMM, van der Lely AJ. Eucaloric Very-Low-Carbohydrate Ketogenic Diet in Acromegaly Treatment. N Engl J Med. 2020 May 28;382(22):2161-2162. doi: 10.1056/NEJMc1915808. No abstract available.
PubMed 32459928
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Deciphering the Role of a Low Protein Diet in Disease Control in Acromegalic Patients
- ClinicalTrials.gov ID
- NCT05298891
- Acronym / sponsor ID
- IpoProAcro / CE 008/22
- Conditions
- Acromegaly
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: ethical issue
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Azienda Ospedaliero Universitaria Maggiore della CaritaUniversity, hospital or other
- Study start
- 1 Dec 2026 (estimated)
- Primary completion
- 1 Dec 2028 (estimated)
- Study completion
- 1 Mar 2029 (estimated)
- First posted
- 28 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Since protein and AAs are master regulator of GH and IGF-I secretion, we hypothesized that a low protein diet could reduce GH and IGF-I levels in acromegalic patients in addition to conventional therapy. Furthermore, we aim to explore metabolomic, microbiota, and micro-vesicle fingerprints of GH hypersecretion during conventional therapy and after a low protein diet
Detailed description
Nutrients are crucial modifiers of the GH/IGF-I axis. In particular, a close cross-talk between proteins and amino acids (AAs) and GH/IGF-I secretion exists.
Both AAs and proteins affect GH secretion. AAs stimulate GH secretion upon oral administration, with different potency among studies, being the combination of arginine and lysine the most powerful. Soy proteins also stimulate GH secretion when ingested either as hydrolysed proteins or free AAs. Furthermore, the acute GH response to AAs ingestion may be influenced by the daily amount of dietary protein/AAs consumption: diets high in proteins apparently increase basal GH levels.
AAs and proteins have a positive effect on IGF-I secretion as well. In general, high levels of proteins, especially animal and dairy proteins, and consumption of branched chain amino acids (BCAAs) increase serum IGF-I levels.
Considering pathological GH conditions, metabolomic analysis of acromegalic patients suggests that the main metabolic fingerprint of GH hypersecretion is a reduction in BCAAs, related to the disease activity. Moreover, there is evidence that GH, rather than IGF-I, is the main mediator of such metabolic fingerprint, which may be related to increased uptake of BCAAs by the muscles, increased gluconeogenesis, and raised consumption of BCAAs.
Thus, in acromegaly, a tailored diet is a further strategy that may contribute to blunt GH/IGF-I secretion. Indeed, some authors recently suggested that "personalized" or "precision" nutrition in some conditions and diseases could have an impact on their phenotype, combining dietary recommendations with individual's genetic makeup, metabolic and microbiome characteristics, and environment. However, studies on precision nutrition in acromegaly are still in a neonatal era.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Acromegalic adult in therapy with somatostatin analogues | Experimental | Other: Usual clinical practice + hypoproteic dietPatients will continue the usual medical outpatient visits cadency and will keep the same pharmacological therapy throughout the whole duration of the study. Drugs have to include somatostatin analogues. At the same time, patients will be trained by an expert dietician in the habit of an isocaloric and hypoproteic diet and will come back at 2,4,6 and 8 weeks after T0 for all the necessary study assessments and compliance checking. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 18/65
- Diagnosis of Acromegaly
- In therapy with somatostatin analogues
Key exclusion criteria (4 listed)
- pregnancy or lactation
- alchool or drugs abuse
- cancer
- Hematological diseases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Usual clinical practice + hypoproteic dietDiet will be composed by: * energy equal to daily energy expenditure (estimated by indirect calorimetry * physical activity factor) * fats 28-35% * carbohydrates 50-60% * proteins 0,7-0,8g/kg of body weight 10-13% Diet will be given to the patient after the first visit and the study will start once the patient begins the diet. | Other | Acromegalic adult in therapy with somatostatin analogues |
Primary outcome
Change in disease related hormones
Time frame: Change from Baseline GH, IGF-1, IGFBP1, IGFBP3 blood levels at 15 days, 30 days, 45 days, 60 days
Variation of GH, IGF-1, IGFBP1, IGFBP3 hormones
16 secondary outcomes
Change in weight
Time frame: Change from Baseline BMI at 15 days, 30 days, 45 days, 60 days
Change in body circumferences
Time frame: Change from Baseline circumferences at 15 days, 30 days, 45 dyas, 60 days
Change in metabolic control
Time frame: Change from Baseline lipid profile at 15 days, 30 days, 45 days, 60 days
Change in metabolic control
Time frame: Change from Baseline lipid profile at 60 days
Change in kidney profile
Time frame: Change from Baseline Serum Creatinin at 15 days, 30 days, 45 days, 60 days
Change in liver profile
Time frame: Change from Baseline Serum Creatinin at 15 days, 30 days, 45 days, 60 days
Change in uric acid
Time frame: Change from Baseline uric acid in blood at 15 days, 30 days, 45 days, 60 days
Change in body composition
Time frame: Change from Baseline fat mass% at 60 days
Change in body composition
Time frame: Change from Baseline fat mass% at 60 days
Change in blood count
Time frame: Change from Baseline blood count at 15 days, 30 days, 45 days, 60 days
Change in microbiota
Time frame: Change from Baseline of prevalence of microbiota phyla at 15, 30 days, 45 days, 60 days
Change in omics profile
Time frame: Change from Baseline omic profile of stools at 15, 30 days, 45 days, 60 days
Change in omics profile
Time frame: Change from Baseline omic profile of stools at 15, 30 days, 45 days, 60 days
Change in microvesicles
Time frame: Change from Baseline microvesicles levels at 15, 30 days, 45 days, 60 days
Change in microvesicles
Time frame: Change from Baseline microvesicles levels s at 15, 30 days, 45 days, 60 days
Change in basal metabolic rate
Time frame: Change from Baseline basal metabolic rate at 60 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2026.
- Background: PubMed 34199514Caputo M, Pigni S, Agosti E, Daffara T, Ferrero A, Filigheddu N, Prodam F. Regulation of GH and GH Signaling by Nutrients. Cells. 2021 Jun 2;10(6):1376. doi: 10.3390/cells10061376.
- Background: PubMed 9063764Suminski RR, Robertson RJ, Goss FL, Arslanian S, Kang J, DaSilva S, Utter AC, Metz KF. Acute effect of amino acid ingestion and resistance exercise on plasma growth hormone concentration in young men. Int J Sport Nutr. 1997 Mar;7(1):48-60. doi: 10.1123/ijsn.7.1.48.
- Background: PubMed 18029456van Vught AJ, Nieuwenhuizen AG, Brummer RJ, Westerterp-Plantenga MS. Effects of oral ingestion of amino acids and proteins on the somatotropic axis. J Clin Endocrinol Metab. 2008 Feb;93(2):584-90. doi: 10.1210/jc.2007-1784. Epub 2007 Nov 20.
- Background: PubMed 6269563Sellini M, Fierro A, Marchesi L, Manzo G, Giovannini C. [Behavior of basal values and circadian rhythm of ACTH, cortisol, PRL and GH in a high-protein diet]. Boll Soc Ital Biol Sper. 1981 May 15;57(9):963-9. Italian.
- Background: PubMed 24606898Levine ME, Suarez JA, Brandhorst S, Balasubramanian P, Cheng CW, Madia F, Fontana L, Mirisola MG, Guevara-Aguirre J, Wan J, Passarino G, Kennedy BK, Wei M, Cohen P, Crimmins EM, Longo VD. Low protein intake is associated with a major reduction in IGF-1, cancer, and overall mortality in the 65 and younger but not older population. Cell Metab. 2014 Mar 4;19(3):407-17. doi: 10.1016/j.cmet.2014.02.006.
- Background: PubMed 12433724Allen NE, Appleby PN, Davey GK, Kaaks R, Rinaldi S, Key TJ. The associations of diet with serum insulin-like growth factor I and its main binding proteins in 292 women meat-eaters, vegetarians, and vegans. Cancer Epidemiol Biomarkers Prev. 2002 Nov;11(11):1441-8.
- Background: PubMed 15277169Hoppe C, Udam TR, Lauritzen L, Molgaard C, Juul A, Michaelsen KF. Animal protein intake, serum insulin-like growth factor I, and growth in healthy 2.5-y-old Danish children. Am J Clin Nutr. 2004 Aug;80(2):447-52. doi: 10.1093/ajcn/80.2.447.
- Background: PubMed 31089868Romo Ventura E, Konigorski S, Rohrmann S, Schneider H, Stalla GK, Pischon T, Linseisen J, Nimptsch K. Association of dietary intake of milk and dairy products with blood concentrations of insulin-like growth factor 1 (IGF-1) in Bavarian adults. Eur J Nutr. 2020 Jun;59(4):1413-1420. doi: 10.1007/s00394-019-01994-7. Epub 2019 May 14.
- Background: PubMed 24094144Beasley JM, Gunter MJ, LaCroix AZ, Prentice RL, Neuhouser ML, Tinker LF, Vitolins MZ, Strickler HD. Associations of serum insulin-like growth factor-I and insulin-like growth factor-binding protein 3 levels with biomarker-calibrated protein, dairy product and milk intake in the Women's Health Initiative. Br J Nutr. 2014 Mar 14;111(5):847-53. doi: 10.1017/S000711451300319X. Epub 2013 Oct 7.
- Background: PubMed 25740607Li R, Ferreira MP, Cooke MB, La Bounty P, Campbell B, Greenwood M, Willoughby DS, Kreider RB. Co-ingestion of carbohydrate with branched-chain amino acids or L-leucine does not preferentially increase serum IGF-1 and expression of myogenic-related genes in response to a single bout of resistance exercise. Amino Acids. 2015 Jun;47(6):1203-13. doi: 10.1007/s00726-015-1947-8. Epub 2015 Mar 5.
- Background: PubMed 32459928Coopmans EC, Berk KAC, El-Sayed N, Neggers SJCMM, van der Lely AJ. Eucaloric Very-Low-Carbohydrate Ketogenic Diet in Acromegaly Treatment. N Engl J Med. 2020 May 28;382(22):2161-2162. doi: 10.1056/NEJMc1915808. No abstract available.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Usual clinical practice + hypoproteic diet in people with Acromegaly, run by Azienda Ospedaliero Universitaria Maggiore della Carita at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: paused, as of the sponsor's last update on 29 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in disease related hormones (time frame: Change from Baseline GH, IGF-1, IGFBP1, IGFBP3 blood levels at 15 days, 30 days, 45 days, 60 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05298891, which also lists 11 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2026.