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

NCT00663000

Last updated date
Study Location
Dept. Internal Medicine, Div. Endocrinology, Charité Campus Mitte, University of Berlin
Berlin, , 10117, Germany
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Acromegaly, Diabetes, Insulin Resistance, Impaired Glucose Tolerance
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-75 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


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).

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Acromegaly, Diabetes, Insulin Resistance, Impaired Glucose ToleranceGlucose Tolerance in Acromegaly: The Influence of GH-excess on Glucose Metabolism and Insulin Resistance
NCT00663000
  1. Berlin,
  2. Dresden,
  3. Magdeburg,
  4. München,
  5. Oldenburg,
  6. Tuebingen,
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
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
Study Design Observational Model: Case-Only
Time Perspective: Cross-Sectional
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples Without DNA
Description:
serum
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
Condition
  • Acromegaly
  • Diabetes
  • Insulin Resistance
  • Impaired Glucose Tolerance
Intervention Not Provided
Study 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
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: September 13, 2014)
138
Original Estimated Enrollment
 (submitted: April 17, 2008)
150
Actual Study Completion Date December 2012
Actual Primary Completion Date April 2011   (Final data collection date for primary outcome measure)
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).
Sex/Gender
Sexes Eligible for Study:All
Ages 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Germany
Removed Location Countries  
 
Administrative Information
NCT Number NCT00663000
Other Study ID Numbers T-7538
T-7538
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Baptist Gallwitz, University Hospital Tuebingen
Study Sponsor University Hospital Tuebingen
Collaborators
  • Pfizer
  • Ludwig-Maximilians - University of Munich
Investigators
Principal Investigator:Baptist Gallwitz, MD, Prof.Dept. Medicine IV. Tuebingen University
PRS Account University Hospital Tuebingen
Verification Date September 2014