Effects of Therapies in the Acromegaly Disease: Acral Morpho-functional Study

NCT05964712 | Recruiting

• 1 other identifier: 40C901
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Acromegaly is a rare chronic disease due to excessive secretion of growth hormone (GH) and insulin-like growth factor-I (IGF-I), caused in over 98% of cases by GH-secreting pituitary adenoma. Prolonged exposure to GH/IGF-I excess is the cause of increased mortality and morbidity in these patients. Arthropathy occurs in about 75% of acromegalic patients. Any joint may be affected, with the development of osteoarthritis, arthralgia, and an increase in fracture risk. The aims of the present project are to evaluate the dimensions of hands and feet with the 3D scanner method and to perform a quantitative analysis of movement through Gait Analysis technique in de novo patients with acromegaly (group # 1) and in patients with different disease status (group #2).

Conditions

Acromegaly

Outcome Measures

Primary Outcomes (8)

• Change in serum concentration of GH and IGF1

  Serum concentration of GH and IGF1

  At baseline in population #1 and # 2 and at 3, 6, 12 months after intervention in population #1

• Change in postural

  The postural evaluation was performed for 60 seconds while the participants were standing on a baropodometric platform (P-Walk, BTSBioengineering, Italy). They were instructed to maintain an upright position, with their eyes focused on a 6 cm black circle placed at their individual eye level, at a distance of 1.5 meters. Subsequently, they were asked to repeat the same task with their eyes closed. To avoid any learning or fatigue effects, two evaluations were acquired with open eyes and two with closed eyes, and between each trial, the subjects were allowed to rest and sit for 2 minutes, maintaining the foot position during the tests. Postural parameters were calculated using dedicated software (G-Studio, BTS, Italy). The relative range of the center of pressure track length is essentially the difference between the maximum and minimum CoP position in the anterior-posterior and medial-lateral (ML) directions during the maintenance of the upright posture.

  At baseline in population #1 and # 2 and at 3, 6, 12 months after intervention in population #1

• Gait analysis

  All participants were evaluated with 3D-Gait Analysis using an optoelectronic system composed of eight cameras (SMARTDX, BTSBioengineering, Italy) set at 100 Hz, and two force platforms (AMTI, USA). To evaluate the kinematics of each body segment, passive markers were positioned on the participants' body, as described by Davis III et al., and the underlying skeletal model was scaled on behalf of anthropometric data (height, weight, tibial length, distance between the femoral condyles or diameter of the knee, distance between the malleoli or diameter of the ankle, distance between the anterior iliac spines and thickness of the pelvis). After placing the markers, the participants were asked to walk barefoot at self-selected speed along a walkway where the force platforms were embedded. Kinematic and kinetic data were collected for each individual from at least five trials to guarantee the reproducibility of the results.

  At baseline in population #1 and # 2 and at 3, 6, 12 months after intervention in population #1

• Change in function of the foot - angle ankle joint

  The functional evaluation of the foot involves positioning the patient prone/supine on the bed and assessing the ankle joint

  At baseline in population #1 and # 2 and at 3, 6, 12 months after intervention in population #1

• Change in function of the foot - angle subtalar joint

  The functional evaluation of the foot involves positioning the patient prone/supine on the bed and assessing the subtalar joint

  At baseline in population #1 and # 2 and at 3, 6, 12 months after intervention in population #1

• Change in function of the foot - angle metatarsophalangeal joint of the big toe

  The functional evaluation of the foot involves positioning the patient prone/supine on the bed and assessing the metatarsophalangeal joint of the big toe

  At baseline in population #1 and # 2 and at 3, 6, 12 months after intervention in population #1

• Change in Function of the hand - Dreiser functional index

  Algo-functional index of the hand according to Dreiser functional index

  At baseline in population #1 and # 2 and at 3, 6, 12 months after intervention in population #1

• Change in Function of the hand - Duruöz hand index

  Algo-functional index of the hand according to Duruöz hand index

  At baseline in population #1 and # 2 and at 3, 6, 12 months after intervention in population #1

Study Arms (2)

Population # 1

De novo patients with acromegaly, diagnosed according to Endocrine Society guidelines, aged equal or above 18 years old

Procedure: Medical surgery therapy

Population # 2

Acromegalic patients with different disease status (active disease despite ongoing therapies, controlled disease under medical therapy, and disease remission), aged equal or above 18 years old

Interventions

Medical surgery therapy PROCEDURE

De novo patients with acromegaly will undergo medical/surgical therapy of this disease, according to the guidelines of the Endocrine Society. In this population (group #1) morpho-functional examinations together with the evaluation of the stage of the disease, with serum dosage of GH and IGF-1, will be performed at baseline and at months 3, 6 and 12 after initiating the treatment.

Population # 1

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Group #1: De novo patients with acromegaly, diagnosed according to Endocrine Society guidelines, aged equal or above 18 years old; Group #2: Acromegalic patients with different disease status (active disease despite ongoing therapies, controlled disease under medical therapy, and disease remission), aged equal or above 18 years old

You may qualify if:

• De novo patients with acromegaly (group # 1), diagnosed according to Endocrine Society guidelines,
• Age equal to18 years or older
• Acromegalic patients with different disease status (group #2)
• Age equal to18 years or older

You may not qualify if:

• Cardiorespiratory, neurological or musculoskeletal disorder
• Previous orthopaedic surgery
• Previous lower limbs traumatic injuries

Sponsors & Collaborators

• Istituto Auxologico Italiano: lead
• Politecnico di Milano: collaborator

Study Sites (1)

Istituto Auxologico Italiano IRCCS San Luca

Milan, 20149, Italy

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

serum dosage of GH and IGF-1

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 Officials

• Giovanni Vitale

  Istituto Auxologico Italiano IRCCS

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sara Farina, Doctor

CONTACT

+393386822298; sara.farina@unimi.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 2, 2023
• First Posted: July 28, 2023
• Study Start: June 18, 2019
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: August 3, 2025

Record last verified: 2025-08

Locations

IT (1)