Glucose Tolerance in Acromegaly: The Influence of GH-excess on Glucose Metabolism and Insulin Resistance
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ClinicalTrials.gov Identifier: NCT00663000 |
Recruitment Status
:
Completed
First Posted
: April 21, 2008
Last Update Posted
: September 16, 2014
|
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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
Condition or disease |
---|
Acromegaly Diabetes Insulin Resistance Impaired Glucose Tolerance |
TRIAL DESIGN Observational, cross-sectional (patients with normal glucose tolerance). longitudinal (patients with impaired glucose tolerance), multi-center, diagnostic study.
After checking the inclusion and exclusion criteria for the cross-sectional part of the study patients will be included for anamnesis according to Flow Chart Visit -1 (Screening Visit). After checking the glucose tolerance and the insulin resistance by HOMA-IR, the patients will be classified to the group with normal glucose tolerance defined as:
-
fasting plasma glucose < 110 mg/dl and/or 2-hour plasma glucose after an OGTT < 140 mg/dl or to the group with impaired glucose tolerance defined as:
- fasting plasma glucose ≥ 110 mg/dl (IFG) and/or 2-hour plasma glucose after an OGTT ≥ 140 mg/dl (IGT). For the HOMA-IR the cut off is 1.5.
For patients with normal glucose tolerance the study will end after Screening Visit (V -1).
After patient recruitment of the cross-sectional part is completed an interim analysis is planned to verify that all criteria for the longitudinal study part are achieved. The longitudinal part should start not later than one year after the last patient was examined in the cross-sectional part. For patients with impaired glucose tolerance the inclusion and exclusion criteria for the longitudinal part of the study will be checked (Baseline, Visit 0). If a patient might be included into the longitudinal part of the study a 12 months observation with 4 further visits will follow.
Primary Objective and Endpoint
Cross-sectional part of the study:
To evaluate a correlation between IGF-I and glucose tolerance in acromegalic patients. The inclusion should be performed in 2 stratification groups.
Following two groups are defined:
- 1/3 of patients with a controlled IGF-I (controlled means IGF-I in age and sex-related normal reference range.
- 2/3 of patients with an uncontrolled IGF-I (uncontrolled means IGF-I not in age and sex related normal reference range.
Longitudinal part of the study:
To evaluate changes of impaired glucose tolerance by different standard treatment options in acromegaly.
For the analysis of the different treatment options patients will be stratified into 5 treatment groups. Decision will be made according to next planned therapeutic intervention at Screening Visit (V -1):
- Surgery
- Treatment with somatostatin analoga (with or without combination of dopamine agonists)
- Treatment with growth hormone receptor antagonist
- Treatment with somatostatin analoga in combination with growth hormone receptor antagonist
- Others (e.g. radiation, dopamine agonist monotherapy, no intervention)
Study Type : | Observational |
Actual Enrollment : | 138 participants |
Observational Model: | Case-Only |
Time Perspective: | Cross-Sectional |
Official Title: | 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. |
Study Start Date : | April 2008 |
Actual Primary Completion Date : | April 2011 |
Actual Study Completion Date : | December 2012 |
Group/Cohort |
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acromegalics
|
- To evaluate a correlation between IGF-I and glucose tolerance in patients with acromegaly.To evaluate changes of impaired glucose tolerance by different treatment options for acromegaly. [ Time Frame: cross-sectional; 1 year longitudinal ]
- Evaluate a correlation between body weight/BMI, age, family history of diabetes,duration of acromegaly and current medical treatment for acromegaly and glucose tolerance / insulin resistance [ Time Frame: cross-sectional, 1 year longitudinal ]
Biospecimen Retention: Samples Without DNA

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Ages Eligible for Study: | 18 Years to 75 Years (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
- 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
Inclusion Criteria:
- 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 Criteria:
- 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).

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00663000
Germany | |
Dept. Internal Medicine, Div. Endocrinology, Charité Campus Mitte, University of Berlin | |
Berlin, Germany, 10117 | |
Endokrinologikum Dresden | |
Dresden, Germany, 01069 | |
Dept. Internal Medicine, Div. Endocrinology, University of Magdeburg | |
Magdeburg, Germany, 39120 | |
Dept. Internal Medicine, Endocrinology, Max Planck Institute for Neuroscience and Psychiatry | |
München, Germany, 80804 | |
Internistische/Endokrinologische Praxis Dr. Droste | |
Oldenburg, Germany, 26122 | |
Dept. Medicine IV | |
Tuebingen, Germany, 72076 |
Principal Investigator: | Baptist Gallwitz, MD, Prof. | Dept. Medicine IV. Tuebingen University |
Publications:
Responsible Party: | Baptist Gallwitz, Prof. Dr. med., University Hospital Tuebingen |
ClinicalTrials.gov Identifier: | NCT00663000 History of Changes |
Other Study ID Numbers: |
T-7538 |
First Posted: | April 21, 2008 Key Record Dates |
Last Update Posted: | September 16, 2014 |
Last Verified: | September 2014 |
Keywords provided by Baptist Gallwitz, University Hospital Tuebingen:
acromegaly diabetes insulin resistance impaired glucose tolerance |
Additional relevant MeSH terms:
Acromegaly Insulin Resistance Glucose Intolerance Hyperinsulinism Glucose Metabolism Disorders Metabolic Diseases Bone Diseases, Endocrine Bone Diseases Musculoskeletal Diseases |
Hyperpituitarism Pituitary Diseases Hypothalamic Diseases Brain Diseases Central Nervous System Diseases Nervous System Diseases Endocrine System Diseases Hyperglycemia |