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Acromegaly clinical trials

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NCT ID: NCT02092129 Active, not recruiting - Surgery Clinical Trials

Pituitary Histopathology and Hyperprolactinaemia and Risk of Glucose Metabolic Disturbances in Acromegaly.

Start date: September 2013
Phase: N/A
Study type: Observational

Acromegaly is frequently associated with impaired glucose tolerance and diabetes. We hypothesise that pituitary histopathology and plasma hyperprolactinaemia could have prognostic value in predicting the risk of glucose metabolic disturbances in acromegalic patients. The aim of this study is to examine glucose metabolic outcome in acromegalic patients with and without histologically verified prolactin and growth hormone (GH) co-secreting adenomas. The study population include 79 patients who have all undergone surgical treatment for acromegaly.

NCT ID: NCT02005978 Active, not recruiting - Acromegaly Clinical Trials

Brain-gut Interaction in Irradiated Patients With Acromegaly

Start date: April 2013
Phase: N/A
Study type: Observational

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.

NCT ID: NCT01809808 Active, not recruiting - Acromegaly Clinical Trials

A Prospective Study of Outcome After Therapy for Acromegaly

Start date: September 2003
Phase:
Study type: Observational

The purpose of this study is to evaluate hormone values and other markers of disease activity in a cohort of patients with acromegaly at the time of diagnosis and then prospectively after surgical or other treatment. This study is designed to determine blood levels of growth hormone and related hormones and cardiovascular risk markers as well as signs and symptoms of the disease at diagnosis and how these parameters change over time after surgical or other therapy. The investigators will also obtain hormonal data in a group of 50 healthy subjects who will each be studied just once with an oral glucose tolerance test (OGTT). These data will provide a comparison group to the acromegaly subjects.

NCT ID: NCT01752621 Active, not recruiting - Acromegaly Clinical Trials

Epidemiology of Acromegaly in Denmark 1991-2010

Start date: February 2013
Phase: N/A
Study type: Observational

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

NCT ID: NCT01265121 Active, not recruiting - Clinical trials for Obstructive Sleep Apnea

Sleep Apnea Syndrome on Acromegaly: Impact of the Treatment on the Carbohydrates Metabolism.

Start date: September 2009
Phase: N/A
Study type: Interventional

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.

NCT ID: NCT00921609 Active, not recruiting - Acromegaly Clinical Trials

Peri-operative Dynamics of the Growth Hormone Axis in Subjects With Acromegaly

Start date: June 2006
Phase:
Study type: Observational

Acromegaly is a rare disorder characterized by excessive production of growth hormone most often by a pituitary adenoma. A pituitary adenoma is a tumor, almost always benign or non-cancerous, that grows on the pituitary, a small gland located at the base of the brain. Treatment of acromegaly usually involves surgery, medication, or radiation, but can involve a combination of these three treatments. Subjects for this study will be recruited if they are: 1. Adults, male or female, between the ages of 18-90. 2. Have been diagnosed with acromegaly, based on elevated levels of growth hormone, IGF-I (a hormone made in response to growth hormone), and a pituitary adenoma visualized on an MRI. 3. Patients would have already agreed to have their acromegaly treated with surgery prior to study entry. Subjects will have measurements of growth hormone using an oral glucose tolerance test (OGTT), IGF-I, free IGF-I and levels of IGF binding proteins at four time points after their pituitary surgery: Day 1, Day 42 (6 weeks), Day 84 (12 weeks), and day 365 (1 year). Subjects will also have an MRI of the pituitary done at 12 weeks and 1 year. OGTT and IGF-I are routinely measured to assess whether or not a person is cured of their acromegaly. An MRI of the pituitary is routinely done at 12 weeks and 1 year after surgery to assess the results of surgery. Free IGF-I and IGF binding proteins are not routinely measured after surgery, but are being done to see if they relate more strongly to disease activity than IGF-I and growth hormone. OGTT and the IGF-I binding proteins are not routinely measured on the day after surgery, but are being done to examine the predictive ability of these tests at a very early time after surgery. Data obtained from these tests will be compared to the data gathered at the 1 year time point. IGF-I and growth hormone will be measured by a commercial clinical lab, Quest Diagnostics, for clinical decision-making at the time of service. IGF-I and growth hormone will also be measured using other methods to attempt to investigate the variability of these hormones when different assays are used.

NCT ID: NCT00600886 Active, not recruiting - Acromegaly Clinical Trials

Safety and Efficacy of Pasireotide Long Acting Release (LAR) vs. Octreotide LAR in Patients With Active Acromegaly

Start date: February 2008
Phase: Phase 3
Study type: Interventional

The patients will receive either Pasireotide LAR or Octreotide LAR for one year of treatment. The objective of this study is to compare the proportion of patients with a reduction of mean GH level to <2.5 µg/L and the normalization of IGF-1 to within normal limits (age and sex related) between the two treatment groups (pasireotide LAR and octreotide LAR) at 12 months. Following one year of treatment patients may proceed into the study extension. Patients who did not respond to the treatment they were randomized to (based on month 12 assessment results) will be switched to the other treatment arm at month 13.