Study Results
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Basic Information
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COMPLETED
53 participants
OBSERVATIONAL
2020-01-01
2020-12-31
Brief Summary
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1. Do isolated hypoglycemia and hypoglycemia with abnormal glucose tolerance have different etiopathogenesis?
2. What is the role of pancreatic insufficiency in these two conditions? Participants were asked to perform 3-h OGTT and to take blood samples. Researchers compared with healthy peers to see if there is isolated hypoglycemia in OGTT and how is the glucagon response to OGTT in healthy peers.
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Detailed Description
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However, the weakness of these limited studies is that nearly all of them included CF patients who had pancreatic insufficiency (PI) and could not reveal the mechanism of hypoglycemia seen in those without PI. In addition, there were no healthy controls for comparison of glucagon secretion in CF patients with hypoglycemia. Moreover, the studies that evaluate the role of glucagon in hypoglycemic CF patients were performed in hypoglycemic adult patients with abnormal glucose tolerance (AGT) and the delayed and prolonged insulin release is expected to be more likely as the reason of hypoglycemia in this setting. Previously, the investigators had demonstrated isolated hypoglycemia in some of the pediatric CF patients during OGTT. In this study, the investigators aimed to further investigate possible mechanisms of hypoglycemia. The investigators hypothesized that the mechanism of isolated hypoglycemia might be different from hypoglycemia seen in patients with AGT. Furthermore, the investigators evaluated the role of pancreatic insufficiency in hypoglycemia of CF patients by analyzing glucose, insulin and glucagon response to a glucose load in CF patients with and without PI.
Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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Cystic Fibrosis
10-18 year-old children with Cystic Fibrosis
No interventions assigned to this group
Healthy Controls
age and sex matched healthy controls
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* Regularly followed by the department of pediatric endocrinology
Exclusion Criteria
* Those who had acute exacerbation in the last 3 months
* Previously diagnosed with diabetes
10 Years
18 Years
ALL
Yes
Sponsors
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Yeditepe University
OTHER
Marmara University
OTHER
Responsible Party
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Principal Investigators
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Belma Haliloglu, MD,PhD
Role: STUDY_DIRECTOR
Marmara University, School of Medicine, Department of Pediatric Endocrinology
Locations
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Marmara University, School of Medicine
Istanbul, , Turkey (Türkiye)
Countries
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References
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Kilberg MJ, Sheikh S, Stefanovski D, Kubrak C, De Leon DD, Hadjiliadis D, Rubenstein RC, Rickels MR, Kelly A. Dysregulated insulin in pancreatic insufficient cystic fibrosis with post-prandial hypoglycemia. J Cyst Fibros. 2020 Mar;19(2):310-315. doi: 10.1016/j.jcf.2019.07.006. Epub 2019 Aug 8.
Kilberg MJ, Harris C, Sheikh S, Stefanovski D, Cuchel M, Kubrak C, Hadjiliadis D, Rubenstein RC, Rickels MR, Kelly A. Hypoglycemia and Islet Dysfunction Following Oral Glucose Tolerance Testing in Pancreatic-Insufficient Cystic Fibrosis. J Clin Endocrinol Metab. 2020 Oct 1;105(10):3179-89. doi: 10.1210/clinem/dgaa448.
Aitken ML, Szkudlinska MA, Boyko EJ, Ng D, Utzschneider KM, Kahn SE. Impaired counterregulatory responses to hypoglycaemia following oral glucose in adults with cystic fibrosis. Diabetologia. 2020 May;63(5):1055-1065. doi: 10.1007/s00125-020-05096-6. Epub 2020 Jan 29.
Armaghanian N, Hetherington J, Parameswaran V, Chua EL, Markovic TP, Brand-Miller J, Steinbeck K. Hypoglycemia in cystic fibrosis during an extended oral glucose tolerance test. Pediatr Pulmonol. 2020 Dec;55(12):3391-3399. doi: 10.1002/ppul.25081. Epub 2020 Oct 16.
Provided Documents
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Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form
Other Identifiers
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09.2019.933
Identifier Type: -
Identifier Source: org_study_id
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