Fractionated Stereotactic Radiotherapy in Patients With Acromegaly. Single Centre Experience
Hypothesis: Fractionated stereotactic radiotherapy is a safe therapy for treatment of patients with acromegaly in terms of both tumour control and biochemical remission
NCT00934271 — Acromegaly
Status: Completed
http://inclinicaltrials.com/acromegaly/NCT00934271/
A Study Examining the Peri- and Post-operative Dynamics of the GH-IGF-1 Axis in Subjects With Acromegaly During the First Year After Surgical Resection
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.
NCT00921609 — Acromegaly
Status: Active, not recruiting
http://inclinicaltrials.com/acromegaly/NCT00921609/
Lanreotide Levels in Acromegaly
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.
NCT00916916 — Acromegaly
Status: Recruiting
http://inclinicaltrials.com/acromegaly/NCT00916916/
Growth Hormone Feedback In Patients With Acromegaly, Type 2 Diabetes Mellitus, And Healthy Adults
Growth hormone (GH) and Insulin-like growth factor-I (IGF-I) secretion are altered in acromegaly and type 2 Diabetes Mellitis (DM). The secretion of GH is mediated by central hypothalamic hormones (GH Releasing Hormone and somatostatin) as well as peripheral factors providing feedback inhibition (IGF-I and glucose, among others). The purpose of this study is to compare growth hormone suppression after an oral glucose tolerance test (OGTT) to growth hormone suppression after recombinant human IGF-I (rhIGF-I) administration. This study will recruit participants with active acromegaly, type 2 diabetes mellitus, and healthy control subjects. Each participant will undergo a screening evaluation, and three subsequent visits. Each participant will receive a placebo subcutaneous injection, OGTT, and administration of rhIGF-I, on separate visit days. Glucose, insulin, GH, bioactive IGF-I and IGF-I binding proteins will be measured after each intervention. Results will be compared between the three groups. It is predicted that the administration of rhIGF-I will demonstrate GH suppression in all healthy subjects and subjects with type 2DM. Some acromegaly subjects may demonstrate GH suppression in response to IGF-I administration, but not to the degree seen in healthy subjects or type 2 DM. OGTT will demonstrate suppression of GH in normal subjects, and will show attenuated suppression in type 2 DM and a failure of suppression in acromegaly.
NCT00915954 — Type 2 Diabetes Mellitus
Status: Completed
http://inclinicaltrials.com/type-2-diabetes-mellitus/NCT00915954/
An Open-Label Study to Evaluate the Pharmacokinetic and Pharmacodynamic Response of a Hydrated and Non-Hydrated 84mg Octreotide Implant in Patients With Acromegaly
To evaluate the pharmacokinetic (PK) and pharmacodynamic (PD) response of a hydrated and non-hydrated 84 mg octreotide implant in patients with acromegaly in the first 6 weeks of treatment.
NCT00913055 — Acromegaly
Status: Completed
http://inclinicaltrials.com/acromegaly/NCT00913055/
Phase III, Open-Label, Multicenter International Study to Evaluate the Efficacy and Safety of an Octreotide Implant vs. Sandostatin LAR Depot in Patients With Acromegaly
Evaluate the efficacy, safety and tolerability of the octreotide implant in patients with acromegaly that were previously treated with octreotide depot.
NCT00765323 — Acromegaly
Status: Terminated
http://inclinicaltrials.com/acromegaly/NCT00765323/
An Observational, Multicentre, Open Label, Non Interventional Programme to Assess the Long-term Safety and Efficacy of Somatuline® Autogel® in the Treatment of Acromegaly When Administered by Patients or Their Partners ("Home Injection Group") or Administered by Healthcare Professionals.
The purpose of this study, is to assess the safety and local tolerability of the long-term use of Somatuline Autogel when administered by patients or their partners ("Home Injection Group") and the safety and local tolerability in patients receiving their injection from a healthcare professional (HCP) ("Reference Group").
NCT00747500 — Acromegaly
Status: Completed
http://inclinicaltrials.com/acromegaly/NCT00747500/
Impact of Somatostatin Analogs vs. Surgery on Glucose Metabolism in Acromegaly: Results of a 5 Years Observational, Open, Prospective Study
To investigate the 60 month impact of surgery and somatostatin analogues (SSA) on glucose metabolism in acromegaly we will analyzed data from 100 patients with acromegaly according with different treatments (group A=with SSA only; group B= SSA followed by surgery; group C= surgery only; group D= surgery followed by SSA). At diagnosis and after 6-12 and 60 months were analyzed as primary outcome measure changes in fasting glucose and as secondary outcome measures changes of glycated hemoglobin (HbA1c) and insulin levels, HOMA-R and HOMA-β, representing insulin resistance and β-cell function, respectively. We will enrol 100 patients and expect half of them to have IGT or diabetes mellitus. We do not expect changes according with different treatment after 60 months while SSA-treated patients might experience deterioration of glucose tolerance after 6-12 months. We intend to look for predictors of deterioration of glucose tolerance.
NCT00703079 — Acromegaly
Status: Completed
http://inclinicaltrials.com/acromegaly/NCT00703079/
Somatuline® Depot (Lanreotide) Injection for Acromegaly (SODA): A Post-marketing Observational Study
To assess the safety and effectiveness of Somatuline® Depot (lanreotide) Injection when administered by a health care professional (HCP), the patient, the patient's partner or parent/guardian as part of their routine acromegaly care.
NCT00686348 — Acromegaly
Status: Completed
http://inclinicaltrials.com/acromegaly/NCT00686348/
Observational, Cross-sectional, Longitudinal, Multi-center, Diagnostic Study to Evaluate the Influence of Acromegaly on Glucose Tolerance and to Evaluate the Changes of Impaired Glucose Tolerance During Standard Treatment of 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
NCT00663000 — Diabetes
Status: Completed
http://inclinicaltrials.com/diabetes/NCT00663000/