Performance and Patient Acceptance of a Commercially Available Beverage as Compared to an Oral Glucose Solution for Oral Glucose Tolerance Tests in Cystic Fibrosis (CF) Patients Who Are Screened for CF-related Diabetes.

NCT05377502 | Unknown

• 1 other identifier: CF OGTT/AATT Study
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Rationale: Cystic fibrosis (CF) is an incurable genetic disease that affects the pulmonary system, digestive system, reproductive system and the sweat glands. 85 percent of patients with cystic fibrosis have pancreatic insufficiency, more than half of whom will develop CFRD. CFRD affects patients nutritional state and is associated with a decline in lung function and decreased longevity. Because early treatment with insulin can reverse some of this decline and mortality, CF patients are screened yearly for CFRD using an oral glucose tolerance test (OGTT). During an OGTT patients have to drink a solution of 75 grams of glucose in water and blood glucose levels are measured after 0 minutes and 120 minutes. Drinking the glucose solutions is experienced by patients as uncomfortable, as it causes nausea and sometimes even leads to vomiting. Therefore, some patients do not want to undergo the OGTT which results in patients getting diagnosed in a later stadium. Objective: To compare the performance of a glucose tolerance test ("AATT") with a commercially available beverage to the results of the conventional OGTT with respect to diagnosing IGT and CFRD in patients with CF. Study design: Randomized crossover trial Study population: Adult cystic fibrosis patients from the outpatient of CF-centre Amsterdam; 10 patients with CFRD who are not fully insulin dependent and 10 patients who have exocrine pancreatic insufficiency but no known CFRD. Intervention (if applicable): The groups will be undergoing both the oral glucose tolerance test with the standard glucose solution (OGTT), as the oral glucose tolerance test where the glucose solution is replaced by commercially available beverage (AATT). Main study parameters/endpoints: Serum glucose levels at 120 minutes after ingestion of either the standard glucose solution or the commercially available beverage. Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Patients who have no known CFRD will be asked to undergo one additional glucose tolerance test, which involves a visit to the outpatient clinic, during which patients need to be fasting since 22:00 the evening before. CF patients already diagnosed with CFRD will be asked to visit the outpatient clinic two times. Patients who use short-acting insulin need to have stopped this as well from 23:59 the evening before the test. These patients may become hyperglycaemic, but since they are not fully insulin dependent there is no risk of keto-acidosis. During the test an I.V. cannula will be placed so blood samples can be taken at baseline, after 30 minutes, 60 minutes, 90 minutes and 120 minutes. There is a minor risk the I.V. cannula will lead to phlebitis. The overall risk for participation in the study is considered low given the fact that patients who are insulin dependent (i.e. also in need of long-acting insulin) are excluded, so the possibility on hyperglycaemia and ketosis seems remote. The commercially available beverage (AA-drink) used is already determined as a safe sports drink by the Food and Consumer Product Safety Authority (NVWA) in the EU.

Conditions

Cystic Fibrosis; Cystic Fibrosis-related Diabetes

Outcome Measures

Primary Outcomes (1)

• Serum glucose levels

  Serum glucose levels at 120 minutes after ingestion of either the standard glucose solution or the sports drink.

  Day of investigation

Interventions

OGTT DIAGNOSTIC_TEST

OGTT

Also known as: AATT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants will be patients diagnosed with CF from the outpatient clinic from the AMC. Patients have to be at least 18 years old and both women and men will be included. Two subsets will be studied: those with CF who have no known CFRD and those who are already diagnosed with CFRD or a disturbed glucose metabolism.

You may qualify if:

• In order to be eligible to participate in this study, a subject must meet all of the following criteria:
• Age ≥ 18
• Diagnosed with CF
• One of the following:
• Diagnosed with CFRD or IGT based on a raise fasting glucose level or OGTT.
• Pancreatic insufficiency, without CFRD

You may not qualify if:

• A potential subject who meets any of the following criteria will be excluded from participation in this study:
• Age \< 18
• Active infection or inflammation
• Use of glucose-lowering drugs and/or medication known to affect insulin secretion or insulin resistance, other than short-acting insulin.
• No informed consent

Sponsors & Collaborators

• Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA): lead

Study Sites (1)

Amsterdam UMC

Amsterdam, Woubruggestraat 28-huis, 1007, Netherlands

RECRUITING

MeSH Terms

Conditions

Cystic Fibrosis

Interventions

Glucose Tolerance Test

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

Intervention Hierarchy (Ancestors)

Blood Chemical Analysis; Clinical Chemistry Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Endocrine; Investigative Techniques

Central Study Contacts

Josje Altenburg

CONTACT

0207323099; j.altenburg@amsterdamumc.nl

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: May 12, 2022
• First Posted: May 17, 2022
• Study Start: December 15, 2021
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: May 17, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)