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| Name | Class |
|---|---|
| Novo Nordisk A/S | INDUSTRY |
Liraglutide is a glucagon like peptide -1 (GLP-1) agonist, which is approved for use in patients with type 2 diabetes. Studies of liraglutide have shown an appetite suppressive effect and has been associated with weight loss in patients with type 2 diabetes. Liraglutide use in the treatment of PWS is limited to one case report by Cyganek et el (See attached Citation). In this case report, the subject showed improvements in hemoglobin A1c and body weight over 14 weeks.
The investigators plan to examine the use of liraglutide in a single subject with Prader Willi Syndrome and type 2 diabetes for one year. The investigators will examine clinical parameters, clinical assessment of hunger, and biochemical markers of diabetes and lipid control.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Liraglutide | Experimental | Treatment of Diabetes Mellitus Type 2 with Liraglutide in the setting of Prader Willi Syndrome |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Liraglutide | Drug | Liraglutide 0.6 mg SQ daily for one week, increase to a maximum dose of 1.8 mg SQ daily by 6 weeks, and subsequent continuation for the remainder of a year. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Hemoglobin A1C | Change from baseline in A1C at 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Fasting Blood Glucose (mmol/L) | Change from baseline in fasting blood glucose at 12 months | |
| Fasting Blood Insulin level | Change from baseline in fasting blood insulin at 12 months | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jason Kong, MD, FRCPC | Vancouver General Hospital, University of British Columbia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vancouver General Hospital - Diamond Center | Vancouver | British Columbia | V5Z 1M9 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21388446 | Background | Cyganek K, Koblik T, Kozek E, Wojcik M, Starzyk J, Malecki MT. Liraglutide therapy in Prader-Willi syndrome. Diabet Med. 2011 Jun;28(6):755-6. doi: 10.1111/j.1464-5491.2011.03280.x. No abstract available. | |
| 21632815 | Background | Sze L, Purtell L, Jenkins A, Loughnan G, Smith E, Herzog H, Sainsbury A, Steinbeck K, Campbell LV, Viardot A. Effects of a single dose of exenatide on appetite, gut hormones, and glucose homeostasis in adults with Prader-Willi syndrome. J Clin Endocrinol Metab. 2011 Aug;96(8):E1314-9. doi: 10.1210/jc.2011-0038. Epub 2011 Jun 1. |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D011218 | Prader-Willi Syndrome |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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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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|
| Body Weight (kg) |
| Change from baseline in body weight at 12 months |
| Fasting Lipid Profile | Change from baseline in fasting lipid profile at 12 months |
| Hip Circumference (cm) | Change from baseline in hip circumference at 12 months |
| Total Body Adipose Tissue Distribution (whole body Computed Tomography) | Change from baseline in total body adipose tissue distribution at 12 months |
| D004700 | Endocrine System Diseases |
| D008607 | Intellectual Disability |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D000015 | Abnormalities, Multiple |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D025063 | Chromosome Disorders |
| D030342 | Genetic Diseases, Inborn |
| D000096803 | Imprinting Disorders |
| D009765 | Obesity |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D006728 |
| Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |