Effects of Therapies in the Acromegaly Disease: Acral Morpho-functional Study
ConditionAcromegaly
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-90
SponsorIstituto Auxologico Italiano
About this trial
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).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Cardiorespiratory, neurological or musculoskeletal disorder
Previous orthopaedic surgery
Previous lower limbs traumatic injuries
Trial 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
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Medical surgery therapy
Procedure/SurgeryDe 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.
Treatment groups
30 Participants
are divided into 2 treatment groupsGroup A: Population # 11 intervention
Group B: Population # 20 interventions
Trial outcomes
Primary outcomes
1
Change in serum concentration of GH and IGF1
Serum concentration of GH and IGF1
Time frame
At baseline in population #1 and # 2 and at 3, 6, 12 months after intervention in population #12
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.
Time frame
At baseline in population #1 and # 2 and at 3, 6, 12 months after intervention in population #13
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.
Time frame
At baseline in population #1 and # 2 and at 3, 6, 12 months after intervention in population #14
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
Time frame
At baseline in population #1 and # 2 and at 3, 6, 12 months after intervention in population #1Sponsors and contacts
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Istituto Auxologico Italiano
Lead sponsor
Politecnico di Milano
Collaborator
Source ClinicalTrials.gov