Hypoglycemia and Glucagon Response in CF

NCT05700604 | Completed DMC

• 1 other identifier: 09.2019.933
• Study Type: observational
• Target: 53
• Locations: 1 country
• Sites: 1

Brief 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. 1.Do isolated hypoglycemia and hypoglycemia with abnormal glucose tolerance have different etiopathogenesis?
2. 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.

Conditions

Cystic Fibrosis; Hypoglycemia; Glucagon Deficiency; Pancreatic Insufficiency

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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.

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

Secondary Outcomes (5)

• HbA1c

  0.minute of oral glucose loading

• C-reactive protein (CRP)

  0.minute of oral glucose loading

• Cortisol

  0-180.minutes of oral glucose loading

• Forced expiratory volume in 1 second (FEV1)

  Within 2 weeks before OGTT

• Body Mass Index (BMI)

  Within 24 hours of OGTT

Study Arms (2)

Cystic Fibrosis

10-18 year-old children with Cystic Fibrosis

Healthy Controls

age and sex matched healthy controls

Eligibility Criteria

• Age: 10 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

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).

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Marmara University: lead
• Yeditepe University: collaborator

Study Sites (1)

Marmara University, School of Medicine

Istanbul, 34854, Turkey (Türkiye)

Location

Related Publications (4)

• 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.

  PMID: 31402215 RESULT

• 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.

  PMID: 32668452 RESULT

• 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.

  PMID: 31993716 RESULT

• 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.

  PMID: 32955169 RESULT

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood samples

MeSH Terms

Conditions

Cystic Fibrosis; Hypoglycemia; Exocrine Pancreatic Insufficiency

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Lung Diseases; Respiratory Tract Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Belma Haliloglu, MD,PhD

  Marmara University, School of Medicine, Department of Pediatric Endocrinology

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 2, 2023
• First Posted: January 26, 2023
• Study Start: January 1, 2020
• Primary Completion: December 31, 2020
• Study Completion: December 31, 2020
• Last Updated: January 26, 2023

Record last verified: 2023-01

Locations

TU (1)