Glucose Tolerance in Acromegaly: The Influence of GH-excess on Glucose Metabolism and Insulin Resistance

This study has been completed.
Sponsor:
Collaborators:
Pfizer
Ludwig-Maximilians - University of Munich
Information provided by (Responsible Party):
Baptist Gallwitz, University Hospital Tuebingen
ClinicalTrials.gov Identifier:
NCT00663000
First received: April 17, 2008
Last updated: September 13, 2014
Last verified: September 2014
  Purpose

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
Acromegaly
Diabetes
Insulin Resistance
Impaired Glucose Tolerance

Study Type: Observational
Study Design: 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.

Resource links provided by NLM:


Further study details as provided by University Hospital Tuebingen:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA

serum


Enrollment: 138
Study Start Date: April 2008
Study Completion Date: December 2012
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
acromegalics
  1. Acromegaly in adult subjects 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).
  2. Written informed consent

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
  1. 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).
  2. Written informed consent
Criteria

Inclusion Criteria:

  1. 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).
  2. Written informed consent

Exclusion Criteria:

  1. 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.
  2. Renal failure (GFR ≤ 30 ml/min)
  3. Abnormal clinical laboratory values considered by the investigator to be clinically significant and which could affect the interpretation of the study results.
  4. 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.
  5. Suspected or known drug or alcohol abuse.
  6. Any condition which in the opinion of the investigator makes the patient unsuitable for inclusion.
  7. Participation in any other clinical trial with an investigational new drug.
  8. 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).
  9. Instable heart insufficiency for example cardiomyopathy, congestive heart failure (NYHA class III or IV), unstable angina, sustained ventricular tachycardia, ventricular fibrillation).
  10. 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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00663000

Locations
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
Sponsors and Collaborators
University Hospital Tuebingen
Pfizer
Ludwig-Maximilians - University of Munich
Investigators
Principal Investigator: Baptist Gallwitz, MD, Prof. Dept. Medicine IV. Tuebingen University
  More Information

Publications:

Responsible Party: Baptist Gallwitz, Prof. Dr. med., University Hospital Tuebingen
ClinicalTrials.gov Identifier: NCT00663000     History of Changes
Other Study ID Numbers: T-7538, T-7538
Study First Received: April 17, 2008
Last Updated: September 13, 2014
Health Authority: Germany: Ethics Commission
Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by University Hospital Tuebingen:
acromegaly
diabetes
insulin resistance
impaired glucose tolerance

Additional relevant MeSH terms:
Acromegaly
Glucose Intolerance
Insulin Resistance
Bone Diseases
Bone Diseases, Endocrine
Brain Diseases
Central Nervous System Diseases
Endocrine System Diseases
Glucose Metabolism Disorders
Hyperglycemia
Hyperinsulinism
Hyperpituitarism
Hypothalamic Diseases
Metabolic Diseases
Musculoskeletal Diseases
Nervous System Diseases
Pituitary Diseases

ClinicalTrials.gov processed this record on October 22, 2014