Active clinical trials for "Acromegaly"

Evaluate biochemical differences in acromegalic patients treated with surgery versus somatostatin analogues (SMS) (after surgery or alone). Hypothesis: Treatment modality exhibit different biochemical responses in acromegaly.

Observational, Cross-sectional, longitudinal, multi-center, diagnostic study Cross-sectional part of the study: To evaluate the influence of acromegaly on glucose tolerance Longitudinal part of the study: To evaluate the changes of impaired glucose tolerance during standard treatment of acromegaly. Adult patients with established acromegaly Cross-sectional part of the study: 150 patients Longitudinal part of the study: 58 patients

Sleep apnea is common in acromegaly and both diseases are independently associated with hypertension and insulin resistance contributing to increased morbidity and mortality. Respiratory polygraphy is a simpler alternative to in-laboratory polysomnography for the management of more symptomatic patients with obstructive sleep apnea. The aim of this study is to evaluate the prevalence of sleep apnea by respiratory polygraphy, and to analyze the effect of transsphenoidal surgery on sleep apnea.

Acromegaly is caused by increased production of growth hormone (GH) from a usually benign pituitary tumor. The disease causes a number of complications including disturbances in glucose metabolism and about 25% of the patients develop diabetes. Most patients are cured upon surgery alone, but many require additional medical treatment, and in rare cases radiotherapy. A disadvantage of radiotherapy is a risk of radiation damage to nearby areas such as the hypothalamus. The true extent of irradiation induced hypothalamic dysfunction, however, remains uncertain. Data have shown significant improvement and often normalization of glucose metabolism upon surgical cure from acromegaly, whereas data suggest that such improvement is less likely in patients receiving additional radiotherapy. The hypothalamus is part of the so-called 'gut-brain axis', where gastrointestinal hormones through interaction with the hypothalamus plays a significant role in the regulation of appetite and glucose metabolism. Incretins are the most prominent gastrointestinal hormones involved, with the incretin-effect referring to food-induced insulin secretion, which in healthy subjects is responsible for up to 70% of the insulin response after oral glucose intake. The investigators hypothesize that radiation conditional influence of the hypothalamus may compromise the gut-brain activity and thereby affect the incretin-effect and gastrointestinal-mediated glucose disposal (GIGD; i.e. sum of all gastrointestinal-derived factors that contribute to glucose metabolism) in patients with acromegaly. The aim of the study is to investigate the long term effect of surgery with or without additional fractionated radiation therapy on glucose metabolism as assessed by incretin-effect and GIGD in acromegaly, in order to identify possible associations with treatment modality. The study population include 24 acromegalic patients who have previously received (N=12) or did not receive (N=12) pituitary irradiation as part of their treatment, and 12 matched healthy controls.

Recently lanreotide (a somatostatin analog) has come into the US marketplace as a commercially available medication approved by the FDA for the treatment of acromegaly. Blood levels in patients getting this drug are unknown and it may be critical to know the levels in patients whose symptoms are poorly controlled. This is a clinical study of a medical device where the following condition is met: This is research on a medical device for which an investigational device exemption application (21 CFR Part 812) is not required. The study is exempt from IDE requirements under 21 CFR 812.2(c)(3): The participants will be 10 CSMC patients who are taking Lanreotide for clinical purposes. After receiving an information sheet and providing verbal consent, the participants will go to their routine blood draw. At this time, they will have an additional 10 cc plasma drawn, which will be sent to Intersciences Institute in Inglewood California to have the lanreotide plasma levels measured. The key points of this study are: Patients will have blood drawn at the same time as they are having blood drawn for routine care to avoid unnecessary sticks. No patient identifiers will be sent to the lab or to any investigators- all plasma tubes will be coded by ISI as a kit and these kits will be given to the physicians. In turn the physician will give the kit to the patients who wish to have their levels measured and the patient will take the kit with them to their routine blood draw. Following the drawing and processing of the blood we will request that the lab just drop the coded plasma tube (and the patient's height weight and monthly lanreotide dose) into the mail in the prepaid mailer. The only information that the investigators will receive is the patient's height, weight and monthly lanreotide dose and the plasma lanreotide level. No more than 10 cc of blood (a couple of tablespoons) will be drawn for lanreotide measurement. Whenever possible plasma (which would otherwise be discarded) will be used rather than freshly drawn blood. All plasma will be assayed at ISI. The patient will not be charged for the lanreotide assay, an investigational assay. The assay is currently investigational and does not have a "maker" at this time.

The purpose of this study is to test the effect of long-acting somatostatin analog medications, taken by patients with acromegaly or carcinoid syndrome, on growth hormone in comparison to healthy controls who are not receiving the medication in order to see whether or not the medication makes the oral glucose test less accurate. The Oral Glucose Tolerance Test (OGTT) is a standard test to measure growth hormone secretion. By comparing GH responses in non-acromegaly subjects taking somatostatin analog treatment, the relative contribution of the medication and the underlying disease state can be analyzed.

Sleep apnea is a common situation that affects up to 80% of acromegalic patients. This disease is linked to disturbance on the carbohydrate metabolism increasing the rates of diabetes. The objective of this trial is to assess (with the euglycemic hyperinsulinemic clamp) the impact of the treatment of sleep apnea, with a continuous positive air pressure device (CPAP), on the insulin resistance.

Aim: To assess the incidence rate, morbidity and mortality of acromegaly in Denmark.

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

Growth hormone (GH) plays a pivotal role in the regulation of body composition including ectopic lipid deposition in insulin sensitive organs like liver and skeletal muscle. Recent evidence indicates that the GH-IGF1 axis affects body composition via regulating mitochondrial oxidation capacity. Thus, excessive GH secretion by a pituitary adenoma (Acromegaly) might be accompanied by increased mitochondrial activity leading to inappropriately low intracellular lipid depots, especially in metabolically active tissue like liver and skeletal muscle. This study aims to assess metabolic activity and intracellular lipid content in skeletal muscle and liver in patients suffering from acromegaly compared to controls by 31P/1H Magnetic resonance spectroscopy before and in follow up examinations 3, 6 and 12 months after initiation of GH lowering treatments including surgery, somatostatinanalogs or pegvisomant, as well as oral glucose tolerance tests at each examination to assess treatment responses and calculate validated parameters for insulin sensitivity and resistance.