Prospective Study on Changes in Acromegaly
Prospective Study on Changes in Acromegaly
Rationale: Acromegaly is the clinical syndrome that results from an excess of growth hormone
 (GH). Craniofacial and hand disproportions due to soft tissue swelling and new bone formation
 are highly prevalent in patients with active acromegaly. Besides the cosmetic aspects, these
 changes can impair the quality of life because of the significant morbidity with respect to
 oral, maxillofacial and hand pathologies as well as respiratory problems such as sleep apnea
 and changes in speech. At present it is unclear if these craniofacial and hand
 disproportions, sleep apnea and speech changes are (partially) reversible after successful
 treatment. Therefore there is no consensus about the information patients should be given
 about (partial) recovery of facial and hand disproportions after treatment and how the
 follow-up with respect to oral, maxillofacial, respiratory and hand pathology should be
 organized. Facial and hand analysis using a 3D stereophotograph and a 3D fusion model of a 3D
 stereophotograph and a 3D skull reconstruction via cone beam computed tomography (CT)-scan
 makes it possible to investigate the craniofacial changes due to acromegaly in all facial
 dimensions together (dentition, bone and soft tissue) and the relational proportions between
 these facial structures. 3D stereophotography can do the same for the soft tissues of the
 hand. Combined with disease specific and general quality of life (QOL) questionnaires, a
 correlation between quality of life and craniofacial and hand disproportions can be
 determined. Combined with sleep- and speech analysis, a correlation between sleep apnea,
 speech and craniofacial disproportions can be determined.

 Primary objective: To investigate the changes in facial- and hand analysis in patients with
 acromegaly as a result of medical treatment and pituitary surgery, and to investigate the
 changes in relational proportions between facial- and hand structures, incidence and severity
 of sleep apnea, incidence and severity of speech changes and QOL.

 Study design: a prospective case-control study. Study population: Approximately thirty
 patients newly diagnosed with acromegaly . The results of facial and hand analysis, sleep
 apnea research and speech analysis of the patient group in different phases of the disease
 will be compared to the results of a healthy control group.

 Main study parameters/endpoints: Parameters of facial analysis with 3D stereophotography and
 cone beam CT and hand analysis with 3D stereophotography , biochemical parameters of disease
 activity, disease related QOL assessed by 2 validated QOL questionnaires (,the AcroQol and
 RAND-36 ), speech analysis, the results of the voice handicap index questionnaire and
 severity of sleep apnea assessed by complete overnight polysomnography and the Epworth
 sleepiness scale questionnaire.

 Nature and extent of the burden and risks associated with participation, benefit and group
 relatedness: As a result of participating in this study, subjects have to undergo a cone beam
 CT. The cone beam CT is associated with exposure to X-ray radiation of 0.069-0.135mSv. This
 is the same amount of radiation as the amount of background radiation that each person
 receives in 7 days time during daily life. No adverse effects are expected from this amount
 of exposure. The investigations will take 10-70 minutes adjacent to every regular outpatient
 clinic visit. In addition , for polysomnography, subjects will be investigated overnight one
 or three times in 2,5 years, depending on the results of the first screening polysomnography.

 Assessment of changes in body appearance, sleep disturbances, speech changes and QOL in a
 prospective longitudinal fashion will increase the knowledge of the impact of the disease on
 patient perception of well-being and functioning and will help us refine the treatment goals
 in patients with acromegaly
Inclusion Criteria:

 -  Newly diagnosed acromegaly

 -  Diagnosis is biochemically confirmed by an increased IGF-1 level (> mean +2 standard
 deviations for age) and insufficient suppression of serum GH levels (e.g. GH levels ≥
 2mU/l) during oral glucose tolerance test.

 -  Subjects should be over 18 years old with the ability to read and comprehend the Dutch
 language

 Exclusion Criteria:

 4.3 Exclusion criteria imaging face:

 -  Pregnancy

 -  Maxillofacial surgical treatment in the past.

 Exclusion criteria 3D imaging of the hand:

 -  Hand surgery in the past

 Exclusion criteria Speech analysis:

 -  Speech pathology unrelated to acromegaly

 Exclusion criteria polysomnography:

 -  Co-morbidities that could influence the prevalence of sleep apnea (e.g. muscular
 dystrophy, known hypothyroidism)