Hypoproteic Diet in Acromegaly

NCT05298891 | Not Yet Recruiting

• 1 other identifier: CE 008/22
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief 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. Furthermore, we aim to explore metabolomic, microbiota, and micro-vesicle fingerprints of GH hypersecretion during conventional therapy and after a low protein diet

Conditions

Acromegaly

Outcome Measures

Primary Outcomes (1)

• Change in disease related hormones

  Variation of GH, IGF-1, IGFBP1, IGFBP3 hormones

  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

  Change from Baseline BMI at 15 days, 30 days, 45 days, 60 days

• Change in body circumferences

  Change from Baseline circumferences at 15 days, 30 days, 45 dyas, 60 days

• Change in metabolic control

  Change from Baseline lipid profile at 15 days, 30 days, 45 days, 60 days

• Change in metabolic control

  Change from Baseline lipid profile at 60 days

• Change in kidney profile

  Change from Baseline Serum Creatinin at 15 days, 30 days, 45 days, 60 days

Study Arms (1)

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.

Other: Usual clinical practice + hypoproteic diet

Interventions

Usual clinical practice + hypoproteic diet OTHER

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.

Acromegalic adult in therapy with somatostatin analogues

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18/65
• Diagnosis of Acromegaly
• In therapy with somatostatin analogues

You may not qualify if:

• pregnancy or lactation
• alchool or drugs abuse
• cancer
• Hematological diseases

Sponsors & Collaborators

• Azienda Ospedaliero Universitaria Maggiore della Carita: lead

Study Sites (1)

: Italy Pediatric Endocrine Service of AOU Maggiore della Carità of Novara; SCDU of Pediatrics, Department of Health Sciences, University of Eastern Piedmont

Novara, 28100, Italy

Location

Related Publications (11)

• 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.

  PMID: 34199514 BACKGROUND

• Suminski 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.

  PMID: 9063764 BACKGROUND

• van 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.

  PMID: 18029456 BACKGROUND

• Sellini 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.

  PMID: 6269563 BACKGROUND

• Levine 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.

  PMID: 24606898 BACKGROUND

• Allen 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.

  PMID: 12433724 BACKGROUND

• Hoppe 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.

  PMID: 15277169 BACKGROUND

• Romo 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.

  PMID: 31089868 BACKGROUND

• Beasley 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.

  PMID: 24094144 BACKGROUND

• Li 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.

  PMID: 25740607 BACKGROUND

• Coopmans 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.

  PMID: 32459928 BACKGROUND

MeSH Terms

Conditions

Acromegaly

Condition Hierarchy (Ancestors)

Bone Diseases, Endocrine; Bone Diseases; Musculoskeletal Diseases; Hyperpituitarism; Pituitary Diseases; Hypothalamic Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associated Prof. in Clinical Nutrition and MD

Study Record Dates

• First Submitted: March 18, 2022
• First Posted: March 28, 2022
• Study Start: September 1, 2024
• Primary Completion: December 1, 2025
• Study Completion: March 1, 2026
• Last Updated: September 28, 2023

Record last verified: 2023-09

Locations

IT (1)