Hypoglycemia & Glucagon Response in CF

Status Completed

Clinical Trial Summary

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: 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.

Clinical Trial Description

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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05700604
Study type	Observational
Source	Marmara University
Contact
Status	Completed
Phase
Start date	January 1, 2020
Completion date	December 31, 2020

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT04696198` - Thoracic Mobility in Cystic Fibrosis Care	N/A
Completed	`NCT00803205` - Study of Ataluren (PTC124™) in Cystic Fibrosis	Phase 3
Terminated	`NCT04921332` - Bright Light Therapy for Depression Symptoms in Adults With Cystic Fibrosis (CF) and COPD	N/A
Completed	`NCT03601637` - Safety and Pharmacokinetic Study of Lumacaftor/Ivacaftor in Participants 1 to Less Than 2 Years of Age With Cystic Fibrosis, Homozygous for F508del	Phase 3
Terminated	`NCT02769637` - Effect of Acid Blockade on Microbiota and Inflammation in Cystic Fibrosis (CF)
Recruiting	`NCT06032273` - Lung Transplant READY CF 2: CARING CF Ancillary RCT	N/A
Recruiting	`NCT06030206` - Lung Transplant READY CF 2: A Multi-site RCT	N/A
Recruiting	`NCT06012084` - The Development and Evaluation of iCF-PWR for Healthy Siblings of Individuals With Cystic Fibrosis	N/A
Recruiting	`NCT05392855` - Symptom Based Performance of Airway Clearance After Starting Highly Effective Modulators for Cystic Fibrosis (SPACE-CF)	N/A
Recruiting	`NCT06088485` - The Effect of Bone Mineral Density in Patients With Adult Cystic Fibrosis
Recruiting	`NCT04056702` - Impact of Triple Combination CFTR Therapy on Sinus Disease.
Recruiting	`NCT04039087` - Sildenafil Exercise: Role of PDE5 Inhibition	Phase 2/Phase 3
Completed	`NCT04038710` - Clinical Outcomes of Triple Combination Therapy in Severe Cystic Fibrosis Disease.
Completed	`NCT04058548` - Clinical Utility of the 1-minute Sit to Stand Test as a Measure of Submaximal Exercise Tolerance in Patients With Cystic Fibrosis During Acute Pulmonary Exacerbation	N/A
Completed	`NCT03637504` - Feasibility of a Mobile Medication Plan Application in CF Patient Care	N/A
Recruiting	`NCT03506061` - Trikafta in Cystic Fibrosis Patients	Phase 2
Completed	`NCT03566550` - Gut Imaging for Function & Transit in Cystic Fibrosis Study 1
Recruiting	`NCT04828382` - Prospective Study of Pregnancy in Women With Cystic Fibrosis
Completed	`NCT04568980` - Assessment of Contraceptive Safety and Effectiveness in Cystic Fibrosis
Recruiting	`NCT04010253` - Impact of Bronchial Drainage Technique by the Medical Device Simeox® on Respiratory Function and Symptoms in Adult Patients With Cystic Fibrosis	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Hypoglycemia and Glucagon Response in CF

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms