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Sponsors and Collaborators: |
University Hospital Tuebingen Pfizer Ludwig-Maximilians - University of Munich |
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Information provided by: | University Hospital Tuebingen |
ClinicalTrials.gov Identifier: | NCT00663000 |
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 |
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Acromegaly Diabetes Insulin Resistance Impaired Glucose Tolerance |
Study Type: | Observational |
Study Design: | Case-Only, 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. |
serum
Estimated Enrollment: | 150 |
Study Start Date: | April 2008 |
Estimated Study Completion Date: | September 2010 |
Estimated Primary Completion Date: | April 2010 (Final data collection date for primary outcome measure) |
Groups/Cohorts |
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acromegalics
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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:
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:
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):
Ages Eligible for Study: | 18 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
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
Exclusion Criteria:
steroid diabetes).
Contact: Baptist Gallwitz, MD, Prof. | 49-707-1298-2093 ext 2093 | baptist.gallwitz@med.uni-tuebingen.de |
Contact: Karsten Muessig, MD | 49-707-1298-0391 ext 0391 | karsten.muessig@med.uni-tuebingen.de |
Germany | |
Dept. Medicine IV | Recruiting |
Tuebingen, Germany, 72076 | |
Contact: Baptist Gallwiltz, MD, Prof. 49-707-1298-2093 ext 2093 baptist.gallwitz@med.uni-tuebingen.de | |
Contact: Karsten Muessig, MD 49-707-1298-0391 ext 0391 karsten.muessig@med.uni-tuebingen.de | |
Sub-Investigator: Karsten Muessig, MD | |
Internistische/Endokrinologische Praxis Dr. Droste | Recruiting |
Oldenburg, Germany, 26122 | |
Contact: Michael Droste, MD +49441219480 droste@endokrin-ol.de | |
Principal Investigator: Michael Droste, MD | |
Sub-Investigator: Inge Runge, MD | |
Dept. Internal Medicine, Div. Endocrinology, University of Magdeburg | Recruiting |
Magdeburg, Germany, 39120 | |
Contact: Kirsten Reschke, MD +493916713109 kirsten.keschke@medizin.uni-magdeburg.de | |
Principal Investigator: Kirsten Reschke, MD | |
Dept. Internal Medicine, Endocrinology, Max Planck Institute for Neuroscience and Psychiatry | Recruiting |
München, Germany, 80804 | |
Contact: Günther K Stalla, MD, Prof. +498930622270 stalla@mpipsykl.mpg.de | |
Principal Investigator: Günther K Stalla, MD, Prof. | |
Endokrinologikum Dresden | Recruiting |
Dresden, Germany, 01069 | |
Contact: Birgit Gerbert, MD +49351795670 birgit.gerbert@endokrinologikum.com | |
Principal Investigator: Birgit Gerbert, MD | |
Dept. Internal Medicine, Div. Endocrinology, Charité Campus Mitte, University of Berlin | Recruiting |
Berlin, Germany, 10117 | |
Contact: Christian Strasburger, MD, Prof. +4930450514152 christian.strasburger@charite.de | |
Principal Investigator: Christian Strasburger, MD, Prof. |
Principal Investigator: | Baptist Gallwitz, MD, Prof. | Dept. Medicine IV. Tuebingen University |
Responsible Party: | Dept. Medicine IV ( Prof. Dr. Baptist Gallwitz / Principal Investigator ) |
Study ID Numbers: | T-7538, T-7538 |
Study First Received: | April 17, 2008 |
Last Updated: | March 2, 2009 |
ClinicalTrials.gov Identifier: | NCT00663000 History of Changes |
Health Authority: | Germany: Ethics Commission; Germany: Federal Institute for Drugs and Medical Devices |
acromegaly diabetes insulin resistance impaired glucose tolerance |
Bone Diseases, Endocrine Hypothalamic Diseases Metabolic Diseases Pituitary Diseases Glucose Intolerance Diabetes Mellitus Central Nervous System Diseases Endocrine System Diseases Brain Diseases Bone Diseases |
Insulin Hyperinsulinism Hyperglycemia Musculoskeletal Diseases Endocrinopathy Insulin Resistance Glucose Metabolism Disorders Metabolic Disorder Acromegaly |
Bone Diseases, Endocrine Hypothalamic Diseases Metabolic Diseases Pituitary Diseases Glucose Intolerance Nervous System Diseases Central Nervous System Diseases Endocrine System Diseases Brain Diseases |
Bone Diseases Hyperinsulinism Hyperglycemia Hyperpituitarism Musculoskeletal Diseases Insulin Resistance Glucose Metabolism Disorders Acromegaly |