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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT02005978
Other study ID # ACRO-INC-TME
Secondary ID
Status Active, not recruiting
Phase N/A
First received November 18, 2013
Last updated September 17, 2016
Start date April 2013
Est. completion date December 2017

Study information

Verified date September 2016
Source Rigshospitalet, Denmark
Contact n/a
Is FDA regulated No
Health authority Denmark: Danish Dataprotection Agency
Study type Observational

Clinical Trial Summary

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.


Description:

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.

Design: observational case-control study Participants: 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.

Investigation: 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.


Recruitment information / eligibility

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

Study Design

Observational Model: Case Control, Time Perspective: Prospective


Related Conditions & MeSH terms


Locations

Country Name City State
Denmark National University Hospital, Department of Medical Endocrinology Copenhagen

Sponsors (2)

Lead Sponsor Collaborator
Rigshospitalet, Denmark University of Copenhagen

Country where clinical trial is conducted

Denmark, 

Outcome

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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