An observational study in Cystic Fibrosis, Hypoglycemia and Glucagon Deficiency, sponsored by Marmara University. Completed at 1 site in Turkey. Open to participants aged 10 Years to 18 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-01-26.
Sponsored by Marmara University · Observational
The goal of this clinical trial is to investigate the etiopathogenesis of isolated hypoglycemia and hypoglycemia with abnormal glucose tolerance in children with Cystic Fibrosis (CF) and to evaluate the role of glucagon and pancreatic insufficiency on hypoglycemia in CF. The main questions it aims to answer are:
The exact underlying mechanism of hypoglycemia in CF is still unknown. Some recent studies support the delayed and prolonged insulin secretion and impaired counterregulatory hormone response as the reason of reactive hypoglycemia, whereas the others argued an additive effect of an intrinsic factor.
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.
1,581 studies on the registry are indexed under Cystic Fibrosis; 190 are open to participants now.
This study's enrollment of 53 is below the median of 85 across 482 observational studies indexed under Cystic Fibrosis.
Browse Cystic Fibrosis studies →Marmara University is the lead sponsor of 576 studies on the registry; 136 are open to participants now.
Counted across the registry records on this site, refreshed daily.
The study population is the children and adolescents aged 10-18 years with CF who were regularly followed-up at the Pediatric Endocrinology and Diabetes Units.
The control group was age-matched healthy, diabetes non-diabetic siblings of patients with type 1 diabetes. All the controls were negative for β-cell autoantibodies (anti-glutamic acid decarboxylase, islet cell antibody, and insulin antibody).
Exclusion Criteria:
10-18 year-old children with Cystic Fibrosis
age and sex matched healthy controls
Change of glucose level
A 3 hour Oral Glucose Tolerance Test (OGTT) was used to evaluate changing and it was performed in the morning following overnight fasting of ≥8 hours. All participants (CF patients and controls) received oral glucose solution (1.75 g/kg; max: 75 g) in 10 minutes.
Time frame: 0-30-60-90-120-150-180.minutes of oral glucose loading
Change of insulin level
A 3 hour Oral Glucose Tolerance Test (OGTT) was used to evaluate changing and it was performed in the morning following overnight fasting of ≥8 hours. All participants (CF patients and controls) received oral glucose solution (1.75 g/kg; max: 75 g) in 10 minutes.
Time frame: 0-30-60-90-120-150-180.minutes of oral glucose loading
Change of glucagon level
A 3 hour Oral Glucose Tolerance Test (OGTT) was used to evaluate changing and it was performed in the morning following overnight fasting of ≥8 hours. All participants (CF patients and controls) received oral glucose solution (1.75 g/kg; max: 75 g) in 10 minutes.
Time frame: 0-60-120-150-180.minutes of oral glucose loading
HbA1c
It was measured by high-performance liquid chromatographic (HPLC) method from venous blood sample
Time frame: 0.minute of oral glucose loading
C-reactive protein (CRP)
It was measured by ELISA from venous blood sample
Time frame: 0.minute of oral glucose loading
Cortisol
The response to hypoglycemia was evaluated during 3 hour Oral Glucose Tolerance Test (OGTT)
Time frame: 0-180.minutes of oral glucose loading
Forced expiratory volume in 1 second (FEV1)
It was measured by spirometry
Time frame: Within 2 weeks before OGTT
Body Mass Index (BMI)
It was calculated as weight (kg)/height (m)2
Time frame: Within 24 hours of OGTT
Documents are hosted by the registry — open the source record to download them.
Plan to share: Undecided — All data except the participants' name-surname can be shared with the other researchers
This study is completed, as verified in Jan 2023. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Marmara University