Trial record 1 of 114 for:    "Acromegaly"
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Glucose Tolerance in Acromegaly: The Influence of GH-excess on Glucose Metabolism and Insulin Resistance

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2009 by University Hospital Tuebingen.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborators:
Pfizer
Ludwig-Maximilians - University of Munich
Information provided by:
University Hospital Tuebingen
ClinicalTrials.gov Identifier:
NCT00663000
First received: April 17, 2008
Last updated: September 21, 2009
Last verified: September 2009
  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


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
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

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 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)
  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: Prof. Dr. Baptist Gallwitz / Principal Investigator, Dept. Medicine IV
ClinicalTrials.gov Identifier: NCT00663000     History of Changes
Other Study ID Numbers: T-7538, T-7538
Study First Received: April 17, 2008
Last Updated: September 21, 2009
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
Diabetes Mellitus
Insulin Resistance
Glucose Intolerance
Bone Diseases, Endocrine
Bone Diseases
Musculoskeletal Diseases
Hyperpituitarism
Pituitary Diseases
Hypothalamic Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Hyperinsulinism
Hyperglycemia

ClinicalTrials.gov processed this record on July 31, 2014