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Completed

NCT Number: NCT05700604

Hypoglycemia and Glucagon Response in CF

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.

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Key information

Conditions

Cystic Fibrosis Congenital, Hereditary, and Neonatal Diseases and Abnormalities Digestive System Diseases Exocrine Pancreatic Insufficiency Genetic Diseases, Inborn Glucagon Deficiency Glucose Metabolism Disorders Hypoglycemia Infant, Newborn, Diseases Lung Diseases Metabolic Diseases Nutritional and Metabolic Diseases Pancreatic Diseases Pancreatic Insufficiency Respiratory Tract Diseases

Age range

10 year–18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Marmara University, School of Medicine

Istanbul, 34854, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 10-18 year-old children genetically diagnosed with Cystic Fibrosis
  • Regularly followed by the department of pediatric endocrinology

Exclusion criteria

  • Using corticosteroid therapy in the last 3 months
  • Those who had acute exacerbation in the last 3 months
  • Previously diagnosed with diabetes

Treatment and study plan

Primary outcomes

  1. Change of glucose level

    Time frame: 0-30-60-90-120-150-180.minutes of oral glucose loading

    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.

  2. Change of insulin level

    Time frame: 0-30-60-90-120-150-180.minutes of oral glucose loading

    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.

  3. Change of glucagon level

    Time frame: 0-60-120-150-180.minutes of oral glucose loading

    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.

Secondary outcomes

  1. HbA1c

    Time frame: 0.minute of oral glucose loading

    It was measured by high-performance liquid chromatographic (HPLC) method from venous blood sample

  2. C-reactive protein (CRP)

    Time frame: 0.minute of oral glucose loading

    It was measured by ELISA from venous blood sample

  3. Cortisol

    Time frame: 0-180.minutes of oral glucose loading

    The response to hypoglycemia was evaluated during 3 hour Oral Glucose Tolerance Test (OGTT)

  4. Forced expiratory volume in 1 second (FEV1)

    Time frame: Within 2 weeks before OGTT

    It was measured by spirometry

  5. Body Mass Index (BMI)

    Time frame: Within 24 hours of OGTT

    It was calculated as weight (kg)/height (m)2

Sponsors and collaborators

Lead sponsor

Marmara University

Other

Collaborators

  • Yeditepe University

Registry information

Official study title

The Effect of Pancreatic Insufficiency on Hypoglycemia and Glucagon Response in Children With Cystic Fibrosis

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Jan 26, 2023
Registry last updated
Jan 26, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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