AcromegalyNCT00663000
Glucose Tolerance in Acromegaly: The Influence of GH-excess on Glucose Metabolism and Insulin Resistance
An observational study of Acromegaly and Diabetes, run by University Hospital Tuebingen at 6 sites in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Acromegaly, Diabetes, Insulin Resistance
- Type of treatment
- Pill or oral medicine
- How many people
- 138 participants
- Where
- 6 sitesGermany
- Study dates
- Apr 2008to Dec 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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).
- Written informed consent
Who cannot join
- 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.
- Renal failure (GFR ≤ 30 ml/min)
- Abnormal clinical laboratory values considered by the investigator to be clinically significant and which could affect the interpretation of the study results.
- 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.
- Suspected or known drug or alcohol abuse.
- Any condition which in the opinion of the investigator makes the patient unsuitable for inclusion.
Show all 10Show fewer
- Participation in any other clinical trial with an investigational new drug.
- 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).
- Instable heart insufficiency for example cardiomyopathy, congestive heart failure (NYHA class III or IV), unstable angina, sustained ventricular tachycardia, ventricular fibrillation).
- 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).
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Germany6 sites
Dept. Internal Medicine, Div. Endocrinology, Charité Campus Mitte, University of Berlin
Berlin, 10117
Endokrinologikum Dresden
Dresden, 01069
Dept. Internal Medicine, Div. Endocrinology, University of Magdeburg
Magdeburg, 39120
Dept. Internal Medicine, Endocrinology, Max Planck Institute for Neuroscience and Psychiatry
München, 80804
Internistische/Endokrinologische Praxis Dr. Droste
Oldenburg, 26122
Dept. Medicine IV
Tübingen, 72076
About this study
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.
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
Read the 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:
- 1/3 of patients with a controlled IGF-I (controlled means IGF-I in age and sex-related normal reference range.
- 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):
- Surgery
- Treatment with somatostatin analoga (with or without combination of dopamine agonists)
- Treatment with growth hormone receptor antagonist
- Treatment with somatostatin analoga in combination with growth hormone receptor antagonist
- Others (e.g. radiation, dopamine agonist monotherapy, no intervention)
- Conditions
- Acromegaly, Diabetes, Insulin Resistance, Impaired Glucose Tolerance
- Keywords
- acromegaly, diabetes, insulin resistance, impaired glucose tolerance
- Medical subject headings
- Acromegaly, Diabetes Mellitus, Insulin Resistance, Glucose Intolerance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: cross-sectional; 1 year longitudinal
Secondary outcomes (1)
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
Measured: cross-sectional, 1 year longitudinal
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2008 (estimated)
- Study startApr 2008
- Primary completionApr 2011
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (39)Papers the sponsor has linked to this study.
- Other trials for AcromegalyStudies of the same condition, open and under way.
- More trials run by University Hospital TuebingenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 138 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Tuebingen
- Sponsor type
- University, hospital or other
- Collaborators
- Pfizer, Ludwig-Maximilians - University of Munich
- Responsible party
- Principal investigator, Baptist Gallwitz, University Hospital Tuebingen
- Investigators
- Baptist Gallwitz, MD, Prof., Principal investigator, Dept. Medicine IV. Tuebingen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00663000
- Sponsor's protocol ID
- T-7538
- Other IDs
- T-7538
- Status last verified
- Sep 2014
- First submitted
- 17 Apr 2008
- Last updated
- 16 Sep 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Abosch A, Tyrrell JB, Lamborn KR, Hannegan LT, Applebury CB, Wilson CB. Transsphenoidal microsurgery for growth hormone-secreting pituitary adenomas: initial outcome and long-term results. J Clin Endocrinol Metab. 1998 Oct;83(10):3411-8. doi: 10.1210/jcem.83.10.5111.
PubMed 9768640Abs R, Verhelst J, Maiter D, Van Acker K, Nobels F, Coolens JL, Mahler C, Beckers A. Cabergoline in the treatment of acromegaly: a study in 64 patients. J Clin Endocrinol Metab. 1998 Feb;83(2):374-8. doi: 10.1210/jcem.83.2.4556.
PubMed 9467544Ahmed S, Elsheikh M, Stratton IM, Page RC, Adams CB, Wass JA. Outcome of transphenoidal surgery for acromegaly and its relationship to surgical experience. Clin Endocrinol (Oxf). 1999 May;50(5):561-7. doi: 10.1046/j.1365-2265.1999.00760.x.
PubMed 10468920Barkan AL, Halasz I, Dornfeld KJ, Jaffe CA, Friberg RD, Chandler WF, Sandler HM. Pituitary irradiation is ineffective in normalizing plasma insulin-like growth factor I in patients with acromegaly. J Clin Endocrinol Metab. 1997 Oct;82(10):3187-91. doi: 10.1210/jcem.82.10.4249.
PubMed 9329336Bates AS, Van't Hoff W, Jones JM, Clayton RN. An audit of outcome of treatment in acromegaly. Q J Med. 1993 May;86(5):293-9.
PubMed 8327647Biermasz NR, van Dulken H, Roelfsema F. Long-term follow-up results of postoperative radiotherapy in 36 patients with acromegaly. J Clin Endocrinol Metab. 2000 Jul;85(7):2476-82. doi: 10.1210/jcem.85.7.6699.
PubMed 10902796Caron P, Tabarin A, Cogne M, Chanson P, Jaquet P. Variable growth hormone profiles following withdrawal of long-term 30mg slow-release lanreotide treatment in acromegalic patients: clinical implications. Eur J Endocrinol. 2000 Jun;142(6):565-71. doi: 10.1530/eje.0.1420565.
PubMed 10822218Clemmons DR. Roles of insulin-like growth factor-I and growth hormone in mediating insulin resistance in acromegaly. Pituitary. 2002;5(3):181-3. doi: 10.1023/a:1023321421760.
PubMed 12812310Colao A, Pivonello R, Auriemma RS, De Martino MC, Bidlingmaier M, Briganti F, Tortora F, Burman P, Kourides IA, Strasburger CJ, Lombardi G. Efficacy of 12-month treatment with the GH receptor antagonist pegvisomant in patients with acromegaly resistant to long-term, high-dose somatostatin analog treatment: effect on IGF-I levels, tumor mass, hypertension and glucose tolerance. Eur J Endocrinol. 2006 Mar;154(3):467-77. doi: 10.1530/eje.1.02112.
PubMed 16498061Davies PH, Stewart SE, Lancranjan L, Sheppard MC, Stewart PM. Long-term therapy with long-acting octreotide (Sandostatin-LAR) for the management of acromegaly. Clin Endocrinol (Oxf). 1998 Mar;48(3):311-6. doi: 10.1046/j.1365-2265.1998.00389.x.
PubMed 9578821Eastman RC, Gorden P, Glatstein E, Roth J. Radiation therapy of acromegaly. Endocrinol Metab Clin North Am. 1992 Sep;21(3):693-712.
PubMed 1521519Elmlinger MW, Kuhnel W, Weber MM, Ranke MB. Reference ranges for two automated chemiluminescent assays for serum insulin-like growth factor I (IGF-I) and IGF-binding protein 3 (IGFBP-3). Clin Chem Lab Med. 2004;42(6):654-64. doi: 10.1515/CCLM.2004.112.
PubMed 15259383Ezzat S, Forster MJ, Berchtold P, Redelmeier DA, Boerlin V, Harris AG. Acromegaly. Clinical and biochemical features in 500 patients. Medicine (Baltimore). 1994 Sep;73(5):233-40.
PubMed 7934807Fahlbusch R, Honegger J, Buchfelder M. Evidence supporting surgery as treatment of choice for acromegaly. J Endocrinol. 1997 Oct;155 Suppl 1:S53-5.
PubMed 9389996Feenstra J, de Herder WW, ten Have SM, van den Beld AW, Feelders RA, Janssen JA, van der Lely AJ. Combined therapy with somatostatin analogues and weekly pegvisomant in active acromegaly. Lancet. 2005 May 7-13;365(9471):1644-6. doi: 10.1016/S0140-6736(05)63011-5.
PubMed 15885297
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT00663000
- Acronym / sponsor ID
- T-7538
- Conditions
- Acromegaly, Diabetes, Insulin Resistance, Impaired Glucose Tolerance
- Keywords
- acromegaly, diabetes, insulin resistance, impaired glucose tolerance
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 138 participants (actual)
- Lead sponsor
- University Hospital TuebingenUniversity, hospital or other
- Collaborators
- Pfizer, Ludwig-Maximilians - University of Munich
- Study start
- Apr 2008
- Primary completion
- Apr 2011 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 21 Apr 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 1/3 of patients with a controlled IGF-I (controlled means IGF-I in age and sex-related normal reference range.
- 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):
- Surgery
- Treatment with somatostatin analoga (with or without combination of dopamine agonists)
- Treatment with growth hormone receptor antagonist
- Treatment with somatostatin analoga in combination with growth hormone receptor antagonist
- Others (e.g. radiation, dopamine agonist monotherapy, no intervention)
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (2 listed)
- 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).
- Written informed consent
Key exclusion criteria (10 listed)
- 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.
- Renal failure (GFR ≤ 30 ml/min)
- Abnormal clinical laboratory values considered by the investigator to be clinically significant and which could affect the interpretation of the study results.
- 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.
- Suspected or known drug or alcohol abuse.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
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.
Time frame: cross-sectional; 1 year longitudinal
1 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
Time frame: cross-sectional, 1 year longitudinal
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2014.
- Background: PubMed 9768640Abosch A, Tyrrell JB, Lamborn KR, Hannegan LT, Applebury CB, Wilson CB. Transsphenoidal microsurgery for growth hormone-secreting pituitary adenomas: initial outcome and long-term results. J Clin Endocrinol Metab. 1998 Oct;83(10):3411-8. doi: 10.1210/jcem.83.10.5111.
- Background: PubMed 9467544Abs R, Verhelst J, Maiter D, Van Acker K, Nobels F, Coolens JL, Mahler C, Beckers A. Cabergoline in the treatment of acromegaly: a study in 64 patients. J Clin Endocrinol Metab. 1998 Feb;83(2):374-8. doi: 10.1210/jcem.83.2.4556.
- Background: PubMed 10468920Ahmed S, Elsheikh M, Stratton IM, Page RC, Adams CB, Wass JA. Outcome of transphenoidal surgery for acromegaly and its relationship to surgical experience. Clin Endocrinol (Oxf). 1999 May;50(5):561-7. doi: 10.1046/j.1365-2265.1999.00760.x.
- Background: PubMed 9329336Barkan AL, Halasz I, Dornfeld KJ, Jaffe CA, Friberg RD, Chandler WF, Sandler HM. Pituitary irradiation is ineffective in normalizing plasma insulin-like growth factor I in patients with acromegaly. J Clin Endocrinol Metab. 1997 Oct;82(10):3187-91. doi: 10.1210/jcem.82.10.4249.
- Background: PubMed 8327647Bates AS, Van't Hoff W, Jones JM, Clayton RN. An audit of outcome of treatment in acromegaly. Q J Med. 1993 May;86(5):293-9.
- Background: PubMed 10902796Biermasz NR, van Dulken H, Roelfsema F. Long-term follow-up results of postoperative radiotherapy in 36 patients with acromegaly. J Clin Endocrinol Metab. 2000 Jul;85(7):2476-82. doi: 10.1210/jcem.85.7.6699.
- Background: PubMed 10822218Caron P, Tabarin A, Cogne M, Chanson P, Jaquet P. Variable growth hormone profiles following withdrawal of long-term 30mg slow-release lanreotide treatment in acromegalic patients: clinical implications. Eur J Endocrinol. 2000 Jun;142(6):565-71. doi: 10.1530/eje.0.1420565.
- Background: PubMed 12812310Clemmons DR. Roles of insulin-like growth factor-I and growth hormone in mediating insulin resistance in acromegaly. Pituitary. 2002;5(3):181-3. doi: 10.1023/a:1023321421760.
- Background: PubMed 16498061Colao A, Pivonello R, Auriemma RS, De Martino MC, Bidlingmaier M, Briganti F, Tortora F, Burman P, Kourides IA, Strasburger CJ, Lombardi G. Efficacy of 12-month treatment with the GH receptor antagonist pegvisomant in patients with acromegaly resistant to long-term, high-dose somatostatin analog treatment: effect on IGF-I levels, tumor mass, hypertension and glucose tolerance. Eur J Endocrinol. 2006 Mar;154(3):467-77. doi: 10.1530/eje.1.02112.
- Background: PubMed 9578821Davies PH, Stewart SE, Lancranjan L, Sheppard MC, Stewart PM. Long-term therapy with long-acting octreotide (Sandostatin-LAR) for the management of acromegaly. Clin Endocrinol (Oxf). 1998 Mar;48(3):311-6. doi: 10.1046/j.1365-2265.1998.00389.x.
- Background: PubMed 1521519Eastman RC, Gorden P, Glatstein E, Roth J. Radiation therapy of acromegaly. Endocrinol Metab Clin North Am. 1992 Sep;21(3):693-712.
- Background: PubMed 15259383Elmlinger MW, Kuhnel W, Weber MM, Ranke MB. Reference ranges for two automated chemiluminescent assays for serum insulin-like growth factor I (IGF-I) and IGF-binding protein 3 (IGFBP-3). Clin Chem Lab Med. 2004;42(6):654-64. doi: 10.1515/CCLM.2004.112.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Baptist Gallwitz, MD, Prof. principal investigator
Dept. Medicine IV. Tuebingen University
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acromegaly and Diabetes, run by University Hospital Tuebingen at 6 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Sep 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00663000, which also lists 39 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2014.