Clinical Trials Logo

Clinical Trial 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).


Clinical Trial Description

This is an observational, prospective study that aims to evaluate the effect of acromegalic disease and medical/surgical therapy on acral morpho-functional alterations. To outline the morphological characteristics of the extremities (hands and feet), a three-dimensional laser scanning system will be used able to measure the geometrical and volumetric characteristics of the hands and feet of these subjects. The three-dimensional scanning system that will be used is the portable FastScan system (marketed by Rodin), previously used for the volumetric evaluation of the lower and upper limbs of subjects suffering from lymphedema and lipedema. The processing of the image and the parameters will be carried out through two softwares: Rodin4DScan, which carries out the reconstruction of the shape after the scan, and Rodin4D, which allows the construction of the final shape and allows the processing of the various parameters to the morphology of the extremity. The following tests will be used to characterize posture and balance control during walking: - maintenance of the bipedal indifferent orthostatic posture, with open and closed eyes; - walking on level ground, barefoot, at natural speed (10 m walking test) The instrumentation (BTS GAITLAB) that will be used consists of: - 8-camera stereophotogrammetric system (SMART DX, BTS-Bioengineering, IT); - two dynamometric platforms (AMTI, USA); - a baropodometric platform (P-WALK; BTS-Bioengineering, IT). The variables analyzed will be divided according to the administered tests: 1. maintenance of the orthostatic posture: anteroposterior and mediolateral excursion of the center of pressure, speed of displacement of the center of pressure, length of postural ball and distribution of plantar pressures; 2. gait: spatio-temporal parameters, kinematics of trunk and joints of lower limbs, ground reaction forces, moments and joint powers. A functional evaluation of the foot will be also performed positioning the patient prone/supine on the bed and measuring several joint angles. The measurement will be supported by a video from which images can be subsequently processed to trace and obtain the joint angles. For the functional evaluation of the hand, the patient will be evaluated with the following outcome measures: 1. Algo-functional index of the hand according to Dreiser, which analyzes the ability to execute some gestures of daily life; 2. Duruöz index, questionnaire for assessing functional impairment of hand. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05964712
Study type Observational
Source Istituto Auxologico Italiano
Contact Sara Farina, Doctor
Phone +393386822298
Email sara.farina@unimi.it
Status Recruiting
Phase
Start date June 18, 2019
Completion date December 31, 2025

See also
  Status Clinical Trial Phase
Recruiting NCT06344650 - Cellular, Molecular and Clinical Determinants of Bone Strength in in Vivo and Human Models of GH Excess. Cross-sectional and Prospective Study
Active, not recruiting NCT02092129 - Pituitary Histopathology and Hyperprolactinaemia and Risk of Glucose Metabolic Disturbances in Acromegaly. N/A
Completed NCT02012127 - Description of Sign-and-symptom Associations at Acromegaly Diagnosis.
Active, not recruiting NCT01265121 - Sleep Apnea Syndrome on Acromegaly: Impact of the Treatment on the Carbohydrates Metabolism. N/A
Terminated NCT00765323 - Efficacy and Safety Study of Octreotide Implant in Patients With Acromegaly Phase 3
Completed NCT00500227 - Predictive Factors of Response to Somatostatin Analogues in Acromegalic Patients With Persistent Disease Following Surgery
Completed NCT00531908 - Physiopathology of Sodium Retention in Acromegaly N/A
Completed NCT01278342 - Study to Evaluate the Efficacy and Safety of Sandostatin LAR at High Dose or in Combination Either With GH-receptor Antagonist or Dopamine-agonist in Acromegalic Patients Phase 4
Active, not recruiting NCT01809808 - A Prospective Study of Outcome After Therapy for Acromegaly
Completed NCT00145405 - Comparable Effects of Lanreotide Autogel and Octreotide LAR on GH, IGF-I Levels and Patient Satisfaction Phase 4
Completed NCT00210457 - Efficacy and Safety of Lanreotide Autogel (60, 90 or 120 mg) in Acromegalic Patients Phase 3
Recruiting NCT05401084 - Diet in the Management of Acromegaly N/A
Recruiting NCT00005100 - Measurement of Outcome of Surgical Treatment in Patients With Acromegaly N/A
Completed NCT00521300 - Preoperative Octreotide Treatment of Acromegaly Phase 4
Completed NCT03548415 - Safety, Tolerability, and Efficacy of IONIS-GHR-LRx in Participants With Acromegaly Being Treated With Long-acting Somatostatin Receptor Ligands Phase 2
Not yet recruiting NCT04066569 - Reproducibility and Utility of OGTT in Acromegaly N/A
Not yet recruiting NCT05298891 - Hypoproteic Diet in Acromegaly N/A
Recruiting NCT04520646 - A Pilot Study of Empagliflozin in the Treatment of Acromegalic Cardiomyopathy N/A
Not yet recruiting NCT04529356 - The TMS Treatment for Postoperative Headache in GH Tumor N/A
Active, not recruiting NCT03252353 - Efficacy and Safety of Octreotide Capsules (MYCAPSSA) in Acromegaly Phase 3