Glucose Tolerance in Acromegaly: The Influence of GH-excess on Glucose Metabolism and Insulin Resistance
NCT ID: NCT00663000
Last Updated: 2014-09-16
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
COMPLETED
Total Enrollment
138 participants
Study Classification
OBSERVATIONAL
Study Start Date
2008-04-30
Study Completion Date
2012-12-31
Brief Summary
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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
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
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Detailed Description
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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:
* 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. 1/3 of patients with a controlled IGF-I (controlled means IGF-I in age and sex-related normal reference range.
2. 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):
1. Surgery
2. Treatment with somatostatin analoga (with or without combination of dopamine agonists)
3. Treatment with growth hormone receptor antagonist
4. Treatment with somatostatin analoga in combination with growth hormone receptor antagonist
5. Others (e.g. radiation, dopamine agonist monotherapy, no intervention)
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. 1/3 of patients with a controlled IGF-I (controlled means IGF-I in age and sex-related normal reference range.
2. 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):
1. Surgery
2. Treatment with somatostatin analoga (with or without combination of dopamine agonists)
3. Treatment with growth hormone receptor antagonist
4. Treatment with somatostatin analoga in combination with growth hormone receptor antagonist
5. Others (e.g. radiation, dopamine agonist monotherapy, no intervention)
Conditions
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Acromegaly
Diabetes
Insulin Resistance
Impaired Glucose Tolerance
Study Design
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Observational Model Type
CASE_ONLY
Study Time Perspective
CROSS_SECTIONAL
Study Groups
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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
No interventions assigned to this group
Eligibility Criteria
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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
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).
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).
Minimum Eligible Age
18 Years
Maximum Eligible Age
75 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Pfizer
INDUSTRY
Sponsor Role
collaborator
Ludwig-Maximilians - University of Munich
OTHER
Sponsor Role
collaborator
University Hospital Tuebingen
OTHER
Sponsor Role
lead
Responsible Party
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Baptist Gallwitz
Prof. Dr. med.
Responsibility Role
PRINCIPAL_INVESTIGATOR
Principal Investigators
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Baptist Gallwitz, MD, Prof.
Role: PRINCIPAL_INVESTIGATOR
Dept. Medicine IV. Tuebingen University
Locations
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Dept. Internal Medicine, Div. Endocrinology, Charité Campus Mitte, University of Berlin
Berlin, , Germany
Site Status
Endokrinologikum Dresden
Dresden, , Germany
Site Status
Dept. Internal Medicine, Div. Endocrinology, University of Magdeburg
Magdeburg, , Germany
Site Status
Dept. Internal Medicine, Endocrinology, Max Planck Institute for Neuroscience and Psychiatry
München, , Germany
Site Status
Internistische/Endokrinologische Praxis Dr. Droste
Oldenburg, , Germany
Site Status
Dept. Medicine IV
Tübingen, , Germany
Site Status
Countries
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Germany
References
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Other Identifiers
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T-7538
Identifier Type: -
Identifier Source: secondary_id
T-7538
Identifier Type: -
Identifier Source: org_study_id
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