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| ID | Type | Description | Link |
|---|---|---|---|
| 2012-001371-37 | EudraCT Number |
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| Name | Class |
|---|---|
| Novo Nordisk A/S | INDUSTRY |
| Rigshospitalet, Denmark | OTHER |
| Hvidovre University Hospital | OTHER |
| Herlev Hospital |
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It is well-known that women with previous gestational diabetes mellitus are in risk of developing type 2 diabetes later in life; approximately half of the women develop overt type 2 diabetes within the first 10 years after pregnancy. Knowing this, we want to examine the effect of the type 2 diabetes medicine, liraglutide (Victoza), in women with previous gestational diabetes with the aim of reducing the risk of developing type 2 diabetes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Liraglutide | Experimental | 1.8 mg liraglutide, subcutaneous, once-daily for five years |
|
| Placebo | Placebo Comparator | Placebo, subcutaneous, once-daily for one year |
|
| Control | No Intervention | Control without previous GDM. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Liraglutide | Drug | 1.8 mg liraglutide |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in glucose tolerance | Changes in glucose is measured by area under the curve for the plasma glucose excursion following a 4-hour 75 g oral glucose tolerance test (OGTT) | from baseline to 52 wks, 53 wks, 260 wks, and 261 wks |
| Measure | Description | Time Frame |
|---|---|---|
| Deterioration in glycaemic status | Percentage of subjects in each treatment arm with normal glucose tolerance (NGT) at inclusion who develop impaired fasting glucose (IFG) and/or impaired glucose tolerance (IGT) or type 2 diabetes; or with IFG or IGT who develop combined IFG/IGT; or with combined IFG/IGT who develop type 2 diabetes | from baseline to 52 wks, 53, wks, 260 wks, and 261 wks |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in glycated hemoglobin | Changes in glycated hemoglobin (HbA1c). From normoglycaemic to prediabetic or type 2 diabetic and from prediabetic to type 2 diabetic or normoglycaemic. | From baseline to 52 wks and 260 wks |
| Changes in anthropometric measurements |
Inclusion Criteria for women with previous GDM:
Exclusion Criteria for women with previous GDM:
Inclusion criteria for women without previous GDM:
Exclusion Criteria for women without previous GDM :
Inclusion Criteria for women without previous GDM and without NAFLD:
Exclusion Criteria for women without previous GDM and without NAFLD:
Inclusion Criteria for women with biopsi-verified NAFLD:
Exclusion Criteria for women with biopsi-verified NAFLD:
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| Name | Affiliation | Role |
|---|---|---|
| Tina Vilsbøll, MD, DMSc | University Hospital Gentofte | Principal Investigator |
| Signe Foghsgaard, MD, PhD | University Hospital Gentofte | Principal Investigator |
| Emilie Skytte Andersen, MD, PhD-student | Steno Diabetes Center Copenhagen | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Metabolic Physiology, Steno Diabetes Center Copenhagen | Hellerup | 2900 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 10842653 | Background | Porte D Jr. Mechanisms for hyperglycemia in the metabolic syndrome. The key role of beta-cell dysfunction. Ann N Y Acad Sci. 1999 Nov 18;892:73-83. doi: 10.1111/j.1749-6632.1999.tb07786.x. | |
| 14968296 | Background | Vilsboll T, Holst JJ. Incretins, insulin secretion and Type 2 diabetes mellitus. Diabetologia. 2004 Mar;47(3):357-366. doi: 10.1007/s00125-004-1342-6. Epub 2004 Feb 13. |
| Label | URL |
|---|---|
| Main website for the University Hospital Gentofte | View source |
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| ID | Term |
|---|---|
| D016640 | Diabetes, Gestational |
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D003920 | Diabetes Mellitus |
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| ID | Term |
|---|---|
| D000069450 | Liraglutide |
| ID | Term |
|---|---|
| D052216 | Glucagon-Like Peptide 1 |
| D004763 | Glucagon-Like Peptides |
| D052336 | Proglucagon |
| D005768 | Gastrointestinal Hormones |
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| OTHER |
| Hillerod Hospital, Denmark | OTHER |
| University of Copenhagen | OTHER |
| The Novo Nordisk Foundation Center for Basic Metabolic Research | OTHER |
| Aarhus University Hospital | OTHER |
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| Placebo | Drug | Liraglutide without the GLP-1 analogue |
|
Changes in body mass index (BMI)(kg/m2), absolute body weight (kg), and waist:hip ratio |
| from baseline to 52 and 260 wks |
| Changes in beta cell secretory responses | changes in area under the curve during OGTT and isoglycemic intravenous glucose infusion (IIGI), the homeostatic model assessment (HOMA) and pro-insulin ratio | from baseline to 52, 53, 260, and 261 wks |
| Changes in insulin sensitivity | assessed by HOMA-IR and Matsuda insulin sensitivity index | from baseline to 52, 53, 260, and 261 wks |
| Changes in incretin hormone secretion | measured as fasting plasma concentrations and plasma responses of GLP-1, GLP2, and GIP and plasma glucagon during OGTT | baseline to 52, 53, 260, and 261 wks |
| Changes in incretin effect | insulin and c-peptide responses after OGTT vs. IIGI | baseline to 52, 53, 260, and 261 wks |
| Changes in presence of non-alcoholic fatty liver disease (NAFLD) | gamma-glutamyltranferase (GGT), intra-heptic fat, FGF-21, whole body and visceral fat mass/fat-free mass, circulating lipids, ultrasound scan and fibroscan | baseline to 52 and 260 wks |
| Changes in cardio-metabolic risk measures | pro-collagen 3, GGT, Intra-hepatic fat, whole body and visceral fat mass/fat-free mass, circulating lipids and cardiovascular biomarkers (highly sensitive c-reactive protein (hs-CRP), N-terminal prohormone of brain natriuretic peptide (NT-proBNP), tumor necrosis factor-alpha (TNF-alpha), adiponectin and plasminogen activator inhibior-1 (PAI-1)) | baseline to 52 and 260 wks |
| Changes in gut microbiota | optional to the main protocol | baseline to 52 and 260 wks |
| Changes in subjective appetite | visual analogue scale (VAS) | baseline to 52, 53, 260, and 261 wks |
| Number of participants with treatment-related adverse events (Safety and tolerability) | as assessed by validated questionnaires | baseline to 52 and 260 wks |
| Change in Quality of life | Assessed by validated questionnaires (SF-36) | Baseline to 52 and 260 wks |
| Evaluation of alcohol consumption | By validated questionnaires | baseline to 52 and 260 wks |
| Evaluation of microalbuminuria | Predicitve value of biomarkers for detection of microalbuminuria | baseline to 52 to 260 wks |
| Evaluation of blindedness of participants and investigators | questionnaire and the end of the blinded trial | baseline to 52 wks |
| Changes in bonemarkers | baseline to 52 and 260 wks |
| 16009062 | Background | Vilsboll T. On the role of the incretin hormones GIP and GLP-1 in the pathogenesis of Type 2 diabetes mellitus. Dan Med Bull. 2004 Nov;51(4):364-70. No abstract available. |
| 17928588 | Background | Holst JJ. The physiology of glucagon-like peptide 1. Physiol Rev. 2007 Oct;87(4):1409-39. doi: 10.1152/physrev.00034.2006. |
| 9742976 | Background | Intensive blood-glucose control with sulphonylureas or insulin compared with conventional treatment and risk of complications in patients with type 2 diabetes (UKPDS 33). UK Prospective Diabetes Study (UKPDS) Group. Lancet. 1998 Sep 12;352(9131):837-53. |
| 8623813 | Background | Damm P, Vestergaard H, Kuhl C, Pedersen O. Impaired insulin-stimulated nonoxidative glucose metabolism in glucose-tolerant women with previous gestational diabetes. Am J Obstet Gynecol. 1996 Feb;174(2):722-9. doi: 10.1016/s0002-9378(96)70456-8. |
| 14634573 | Background | Jensen DM, Molsted-Pedersen L, Beck-Nielsen H, Westergaard JG, Ovesen P, Damm P. Screening for gestational diabetes mellitus by a model based on risk indicators: a prospective study. Am J Obstet Gynecol. 2003 Nov;189(5):1383-8. doi: 10.1067/s0002-9378(03)00601-x. |
| 9704245 | Background | Metzger BE, Coustan DR. Summary and recommendations of the Fourth International Workshop-Conference on Gestational Diabetes Mellitus. The Organizing Committee. Diabetes Care. 1998 Aug;21 Suppl 2:B161-7. No abstract available. |
| 15111544 | Background | Lauenborg J, Hansen T, Jensen DM, Vestergaard H, Molsted-Pedersen L, Hornnes P, Locht H, Pedersen O, Damm P. Increasing incidence of diabetes after gestational diabetes: a long-term follow-up in a Danish population. Diabetes Care. 2004 May;27(5):1194-9. doi: 10.2337/diacare.27.5.1194. |
| 20682697 | Background | Xiang AH, Kjos SL, Takayanagi M, Trigo E, Buchanan TA. Detailed physiological characterization of the development of type 2 diabetes in Hispanic women with prior gestational diabetes mellitus. Diabetes. 2010 Oct;59(10):2625-30. doi: 10.2337/db10-0521. Epub 2010 Aug 3. |
| 12027921 | Background | Hanna FW, Peters JR. Screening for gestational diabetes; past, present and future. Diabet Med. 2002 May;19(5):351-8. doi: 10.1046/j.1464-5491.2002.00684.x. |
| 11776065 | Background | Bian X, Gao P, Xiong X, Xu H, Qian M, Liu S. Risk factors for development of diabetes mellitus in women with a history of gestational diabetes mellitus. Chin Med J (Engl). 2000 Aug;113(8):759-62. |
| 9715377 | Background | Gerich JE. The genetic basis of type 2 diabetes mellitus: impaired insulin secretion versus impaired insulin sensitivity. Endocr Rev. 1998 Aug;19(4):491-503. doi: 10.1210/edrv.19.4.0338. |
| 21153530 | Background | Forbes S, Taylor-Robinson SD, Patel N, Allan P, Walker BR, Johnston DG. Increased prevalence of non-alcoholic fatty liver disease in European women with a history of gestational diabetes. Diabetologia. 2011 Mar;54(3):641-7. doi: 10.1007/s00125-010-2009-0. Epub 2010 Dec 12. |
| 19853906 | Background | Astrup A, Rossner S, Van Gaal L, Rissanen A, Niskanen L, Al Hakim M, Madsen J, Rasmussen MF, Lean ME; NN8022-1807 Study Group. Effects of liraglutide in the treatment of obesity: a randomised, double-blind, placebo-controlled study. Lancet. 2009 Nov 7;374(9701):1606-16. doi: 10.1016/S0140-6736(09)61375-1. Epub 2009 Oct 23. |
| 21844879 | Background | Astrup A, Carraro R, Finer N, Harper A, Kunesova M, Lean ME, Niskanen L, Rasmussen MF, Rissanen A, Rossner S, Savolainen MJ, Van Gaal L; NN8022-1807 Investigators. Safety, tolerability and sustained weight loss over 2 years with the once-daily human GLP-1 analog, liraglutide. Int J Obes (Lond). 2012 Jun;36(6):843-54. doi: 10.1038/ijo.2011.158. Epub 2011 Aug 16. |
| 10702749 | Background | Flint A, Raben A, Blundell JE, Astrup A. Reproducibility, power and validity of visual analogue scales in assessment of appetite sensations in single test meal studies. Int J Obes Relat Metab Disord. 2000 Jan;24(1):38-48. doi: 10.1038/sj.ijo.0801083. |
| 9449682 | Background | Flint A, Raben A, Astrup A, Holst JJ. Glucagon-like peptide 1 promotes satiety and suppresses energy intake in humans. J Clin Invest. 1998 Feb 1;101(3):515-20. doi: 10.1172/JCI990. |
| 24176797 | Derived | Foghsgaard S, Vedtofte L, Mathiesen ER, Svare JA, Gluud LL, Holst JJ, Damm P, Knop FK, Vilsboll T. The effect of a glucagon-like peptide-1 receptor agonist on glucose tolerance in women with previous gestational diabetes mellitus: protocol for an investigator-initiated, randomised, placebo-controlled, double-blinded, parallel intervention trial. BMJ Open. 2013 Oct 30;3(10):e003834. doi: 10.1136/bmjopen-2013-003834. |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D006728 |
| Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |