Diabetes Clinical Trial
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
Status | Completed |
Enrollment | 138 |
Est. completion date | December 2012 |
Est. primary completion date | April 2011 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 75 Years |
Eligibility |
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). |
Observational Model: Case-Only, Time Perspective: Cross-Sectional
Country | Name | City | State |
---|---|---|---|
Germany | Dept. Internal Medicine, Div. Endocrinology, Charité Campus Mitte, University of Berlin | Berlin | |
Germany | Endokrinologikum Dresden | Dresden | |
Germany | Dept. Internal Medicine, Div. Endocrinology, University of Magdeburg | Magdeburg | |
Germany | Dept. Internal Medicine, Endocrinology, Max Planck Institute for Neuroscience and Psychiatry | München | |
Germany | Internistische/Endokrinologische Praxis Dr. Droste | Oldenburg | |
Germany | Dept. Medicine IV | Tuebingen |
Lead Sponsor | Collaborator |
---|---|
University Hospital Tuebingen | Ludwig-Maximilians - University of Munich, Pfizer |
Germany,
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. — View Citation
Abs 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. — View Citation
Ahmed 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. — View Citation
Barkan 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. — View Citation
Bates 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. — View Citation
Biermasz 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. — View Citation
Caron 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. — View Citation
Clemmons DR. Roles of insulin-like growth factor-I and growth hormone in mediating insulin resistance in acromegaly. Pituitary. 2002;5(3):181-3. Review. — View Citation
Colao 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. — View Citation
Davies 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. Erratum in: Clin Endocrinol (Oxf) 1998 May;48(5):673. — View Citation
Eastman RC, Gorden P, Glatstein E, Roth J. Radiation therapy of acromegaly. Endocrinol Metab Clin North Am. 1992 Sep;21(3):693-712. Review. — View Citation
Elmlinger MW, Kühnel 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. — View Citation
Ezzat 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. — View Citation
Fahlbusch R, Honegger J, Buchfelder M. Evidence supporting surgery as treatment of choice for acromegaly. J Endocrinol. 1997 Oct;155 Suppl 1:S53-5. — View Citation
Feenstra 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. Erratum in: Lancet. 2005 May;365(9471):1620. — View Citation
Feenstra J, van Aken MO, de Herder WW, Feelders RA, van der Lely AJ. Drug-induced hepatitis in an acromegalic patient during combined treatment with pegvisomant and octreotide long-acting repeatable attributed to the use of pegvisomant. Eur J Endocrinol. 2006 Jun;154(6):805-6. — View Citation
Fløgstad AK, Halse J, Bakke S, Lancranjan I, Marbach P, Bruns C, Jervell J. Sandostatin LAR in acromegalic patients: long-term treatment. J Clin Endocrinol Metab. 1997 Jan;82(1):23-8. — View Citation
Giustina A, Barkan A, Casanueva FF, Cavagnini F, Frohman L, Ho K, Veldhuis J, Wass J, Von Werder K, Melmed S. Criteria for cure of acromegaly: a consensus statement. J Clin Endocrinol Metab. 2000 Feb;85(2):526-9. Review. — View Citation
Hansen I, Tsalikian E, Beaufrere B, Gerich J, Haymond M, Rizza R. Insulin resistance in acromegaly: defects in both hepatic and extrahepatic insulin action. Am J Physiol. 1986 Mar;250(3 Pt 1):E269-73. — View Citation
Hunter SJ, Shaw JA, Lee KO, Wood PJ, Atkinson AB, Bevan JS. Comparison of monthly intramuscular injections of Sandostatin LAR with multiple subcutaneous injections of octreotide in the treatment of acromegaly; effects on growth hormone and other markers of growth hormone secretion. Clin Endocrinol (Oxf). 1999 Feb;50(2):245-51. — View Citation
Jaffe CA, Barkan AL. Treatment of acromegaly with dopamine agonists. Endocrinol Metab Clin North Am. 1992 Sep;21(3):713-35. Review. — View Citation
Jørgensen JO, Feldt-Rasmussen U, Frystyk J, Chen JW, Kristensen LØ, Hagen C, Ørskov H. Cotreatment of acromegaly with a somatostatin analog and a growth hormone receptor antagonist. J Clin Endocrinol Metab. 2005 Oct;90(10):5627-31. Epub 2005 Jul 26. — View Citation
Matthews DR, Hosker JP, Rudenski AS, Naylor BA, Treacher DF, Turner RC. Homeostasis model assessment: insulin resistance and beta-cell function from fasting plasma glucose and insulin concentrations in man. Diabetologia. 1985 Jul;28(7):412-9. — View Citation
Melmed S. Acromegaly. N Engl J Med. 1990 Apr 5;322(14):966-77. Review. — View Citation
Møller N, Schmitz O, Jøorgensen JO, Astrup J, Bak JF, Christensen SE, Alberti KG, Weeke J. Basal- and insulin-stimulated substrate metabolism in patients with active acromegaly before and after adenomectomy. J Clin Endocrinol Metab. 1992 May;74(5):1012-9. — View Citation
Orme SM, McNally RJ, Cartwright RA, Belchetz PE. Mortality and cancer incidence in acromegaly: a retrospective cohort study. United Kingdom Acromegaly Study Group. J Clin Endocrinol Metab. 1998 Aug;83(8):2730-4. — View Citation
Osman IA, James RA, Chatterjee S, Mathias D, Kendall-Taylor P. Factors determining the long-term outcome of surgery for acromegaly. QJM. 1994 Oct;87(10):617-23. — View Citation
Rajasoorya C, Holdaway IM, Wrightson P, Scott DJ, Ibbertson HK. Determinants of clinical outcome and survival in acromegaly. Clin Endocrinol (Oxf). 1994 Jul;41(1):95-102. — View Citation
Rose DR, Clemmons DR. Growth hormone receptor antagonist improves insulin resistance in acromegaly. Growth Horm IGF Res. 2002 Dec;12(6):418-24. — View Citation
Saccà L, Cittadini A, Fazio S. Growth hormone and the heart. Endocr Rev. 1994 Oct;15(5):555-73. Review. — View Citation
Schreiber I, Buchfelder M, Droste M, Forssmann K, Mann K, Saller B, Strasburger CJ; German Pegvisomant Investigators. Treatment of acromegaly with the GH receptor antagonist pegvisomant in clinical practice: safety and efficacy evaluation from the German Pegvisomant Observational Study. Eur J Endocrinol. 2007 Jan;156(1):75-82. — View Citation
Stumvoll M, Van Haeften T, Fritsche A, Gerich J. Oral glucose tolerance test indexes for insulin sensitivity and secretion based on various availabilities of sampling times. Diabetes Care. 2001 Apr;24(4):796-7. — View Citation
Swearingen B, Barker FG 2nd, Katznelson L, Biller BM, Grinspoon S, Klibanski A, Moayeri N, Black PM, Zervas NT. Long-term mortality after transsphenoidal surgery and adjunctive therapy for acromegaly. J Clin Endocrinol Metab. 1998 Oct;83(10):3419-26. — View Citation
Sze L, Schmid C, Bloch KE, Bernays R, Brändle M. Effect of transsphenoidal surgery on sleep apnoea in acromegaly. Eur J Endocrinol. 2007 Mar;156(3):321-9. — View Citation
Tindall GT, Oyesiku NM, Watts NB, Clark RV, Christy JH, Adams DA. Transsphenoidal adenomectomy for growth hormone-secreting pituitary adenomas in acromegaly: outcome analysis and determinants of failure. J Neurosurg. 1993 Feb;78(2):205-15. — View Citation
van der Lely AJ, de Herder WW, Lamberts SW. A risk-benefit assessment of octreotide in the treatment of acromegaly. Drug Saf. 1997 Nov;17(5):317-24. Review. — View Citation
van der Lely AJ, Muller A, Janssen JA, Davis RJ, Zib KA, Scarlett JA, Lamberts SW. Control of tumor size and disease activity during cotreatment with octreotide and the growth hormone receptor antagonist pegvisomant in an acromegalic patient. J Clin Endocrinol Metab. 2001 Feb;86(2):478-81. — View Citation
Veysey MJ, Thomas LA, Mallet AI, Jenkins PJ, Besser GM, Wass JA, Murphy GM, Dowling RH. Prolonged large bowel transit increases serum deoxycholic acid: a risk factor for octreotide induced gallstones. Gut. 1999 May;44(5):675-81. — View Citation
Wasada T, Aoki K, Sato A, Katsumori K, Muto K, Tomonaga O, Yokoyama H, Iwasaki N, Babazono T, Takahashi C, Iwamoto Y, Omori Y, Hizuka N. Assessment of insulin resistance in acromegaly associated with diabetes mellitus before and after transsphenoidal adenomectomy. Endocr J. 1997 Aug;44(4):617-20. — View Citation
* Note: There are 39 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | cross-sectional; 1 year longitudinal | No | |
Secondary | 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 | cross-sectional, 1 year longitudinal | No |
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