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

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Brief Title

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

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.

Brief Summary

      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
    

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)
    


Study Type

Observational


Primary Outcome

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.

Secondary Outcome

 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

Condition

Acromegaly


Study Arms / Comparison Groups

 acromegalics
Description:  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).
Written informed consent

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information



Estimated Enrollment

138

Start Date

April 2008

Completion Date

December 2012

Primary Completion Date

April 2011

Eligibility 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).
      

Gender

All

Ages

18 Years - 75 Years

Accepts Healthy Volunteers

No

Contacts

Baptist Gallwitz, MD, Prof., , 

Location Countries

Germany

Location Countries

Germany

Administrative Informations


NCT ID

NCT00663000

Organization ID

T-7538

Secondary IDs

T-7538

Responsible Party

Principal Investigator

Study Sponsor

University Hospital Tuebingen

Collaborators

 Pfizer

Study Sponsor

Baptist Gallwitz, MD, Prof., Principal Investigator, Dept. Medicine IV. Tuebingen University


Verification Date

September 2014