Acromegaly Clinical Trial
Official title:
Incretin Effect and Gastrointestinally Mediated Glucose Disposal in Cranially Irradiated Patients With Acromegaly
Verified date | September 2016 |
Source | Rigshospitalet, Denmark |
Contact | n/a |
Is FDA regulated | No |
Health authority | Denmark: Danish Dataprotection Agency |
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.
Status | Active, not recruiting |
Enrollment | 36 |
Est. completion date | December 2017 |
Est. primary completion date | July 2017 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 18 Years to 70 Years |
Eligibility |
Inclusion Criteria: - Age = 18 years - Diagnosis of acromegaly, and treated at the department of Endocrinology, Copenhagen University Hospital, Rigshospitalet, Denmark (tertiary referral hospital) Exclusion Criteria: - Diabetes mellitus - Pregnancy or breastfeeding - Treatment with medications potentially influencing glucose metabolism, including thiazides and steroids (replacement therapy with hydrocortisone not included but matched for). - Chronic or earlier events of acute pancreatitis - Inflammatory bowel disease (Mb. Crohn/ulcerous colitis) - Bowel resection or larger gastrointestinal surgical interventions - Blood percent < 6.5 mmol/L |
Observational Model: Case Control, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
Denmark | National University Hospital, Department of Medical Endocrinology | Copenhagen |
Lead Sponsor | Collaborator |
---|---|
Rigshospitalet, Denmark | University of Copenhagen |
Denmark,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Measure the incretin effect during glucose tolerance tests in acromegaly | Extended oral glucose tolerance test (OGTT), followed by isoglycaemic intravenous glucose infusion (IGII) with concurrent measurement of plasma-glucose, -insulin, -C-peptide, -glucagon, glucagon-like peptide-1 (GLP-1) and glucose-dependent insulinotropic peptide (GIP) at fixed time-points. | one year | No |
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