Status:
COMPLETED
Glucose Tolerance in Acromegaly: The Influence of GH-excess on Glucose Metabolism and Insulin Resistance
Lead Sponsor:
University Hospital Tuebingen
Collaborating Sponsors:
Pfizer
Ludwig-Maximilians - University of Munich
Conditions:
Acromegaly
Diabetes
Eligibility:
All Genders
18-75 years
Brief Summary
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 ...
Detailed Description
TRIAL DESIGN Observational, cross-sectional (patients with normal glucose tolerance). longitudinal (patients with impaired glucose tolerance), multi-center, diagnostic study. After checking the inclu...
Eligibility Criteria
Inclusion
- Acromegaly in adult subjects (≥ 18 years) either controlled or uncontrolled (Diagnosis should be based on OGTT where Acromegaly is defined as a lack of suppression of GH nadir to \< 0.5 ng/dL, after oral administration of 75 g of glucose, OGTT and IGF-I levels at least 10 % above the normal value ± 2 SD).
- Written informed consent
Exclusion
- Liver disease such as cirrhosis, chronic active hepatitis or chronic persistent hepatitis, or persistent ALT, AST, alkaline phosphatase 3 x \> upper limit of normal, or total bilirubin 2 x \> upper limit of normal.
- Renal failure (GFR ≤ 30 ml/min)
- Abnormal clinical laboratory values considered by the investigator to be clinically significant and which could affect the interpretation of the study results.
- History of malignancy of any organ system, treated or untreated, within the past 3 years whether or not there is evidence of local recurrence or metastases, with the exception of localized basal cell carcinoma of the skin.
- Suspected or known drug or alcohol abuse.
- Any condition which in the opinion of the investigator makes the patient unsuitable for inclusion.
- Participation in any other clinical trial with an investigational new drug.
- Patients on longterm, continuous (more than 2 weeks/year) systemic therapy with glucocorticosteroids with exception of a substitution of a pituitary lack of ACTH/cortisol (e.g. patients with panhypopituitarism).
- Instable heart insufficiency for example cardiomyopathy, congestive heart failure (NYHA class III or IV), unstable angina, sustained ventricular tachycardia, ventricular fibrillation).
- Type I diabetes according to the guidelines of the European Diabetes Society or obvious other manifestations of other forms of diabetes (e.g. steroid diabetes).
Key Trial Info
Start Date :
April 1 2008
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 1 2012
Estimated Enrollment :
138 Patients enrolled
Trial Details
Trial ID
NCT00663000
Start Date
April 1 2008
End Date
December 1 2012
Last Update
September 16 2014
Active Locations (6)
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1
Dept. Internal Medicine, Div. Endocrinology, Charité Campus Mitte, University of Berlin
Berlin, Germany, 10117
2
Endokrinologikum Dresden
Dresden, Germany, 01069
3
Dept. Internal Medicine, Div. Endocrinology, University of Magdeburg
Magdeburg, Germany, 39120
4
Dept. Internal Medicine, Endocrinology, Max Planck Institute for Neuroscience and Psychiatry
München, Germany, 80804