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Cystic Fibrosis-related Diabetes clinical trials

View clinical trials related to Cystic Fibrosis-related Diabetes.

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NCT ID: NCT06149793 Recruiting - Cystic Fibrosis Clinical Trials

SGLT2 Inhibitor Therapy in Cystic Fibrosis-related Diabetes

Start date: December 30, 2023
Phase: Phase 2/Phase 3
Study type: Interventional

This will be a placebo-controlled, randomized, double blind, crossover study with a 4 week wash out period. Collect pilot data on the safety, tolerability, and feasibility of empagliflozin therapy in overweight/obese patients with CFRD to support a future larger randomized controlled trial.

NCT ID: NCT06084468 Active, not recruiting - Stroke Clinical Trials

Cardiac Structure and Function in Patients With Cystic Fibrosis

Start date: January 1, 2023
Phase:
Study type: Observational

In a prospective observational cohort study (n = 100), the investigators aim to assess the correlation between cardiac biomarkers, advanced echocardiography and cystic fibrosis genotype and severity and determine whether these are prognostic markers of heart disease in patients suffering from cystic fibrosis (CF).

NCT ID: NCT05788965 Recruiting - Cystic Fibrosis Clinical Trials

Semaglutide in CFRD

Start date: April 30, 2023
Phase: Phase 2/Phase 3
Study type: Interventional

This open label, single arm pilot study, will examine the safety and tolerability of GLP-1RA semaglutide as an add-on therapy to insulin for overweight/obese adult patients with cystic fibrosis related diabetes (CFRD).

NCT ID: NCT05766774 Recruiting - Cystic Fibrosis Clinical Trials

FEED-Cystic Fibrosis (FEED-CF)

FEED-CF
Start date: June 28, 2023
Phase: N/A
Study type: Interventional

The goal of this study is to determine the extent to which excess dietary sugars serve as a precipitating factor in glucose intolerance in adults with cystic fibrosis (CF), a population at especially high risk for a unique form of diabetes (CF-related diabetes, CFRD) and with standard-of-care dietary recommendations (high-calorie, high-fat) that conflict with recommendations for other forms of diabetes. This trial will investigate if the typical high-sugar, high-fat CF diet plays a role in diabetes risk and visceral fat accumulation in people with CF. A total of 30 participants will get a low-added sugar, high-fat diet and the other 30 will get a standard CF diet with no sugar restrictions. Participants will be randomized to the diet group they are assigned. All foods will be provided for 8 weeks.

NCT ID: NCT05723445 Recruiting - Cystic Fibrosis Clinical Trials

The Effects of a Low Glycemic Load Diet on Dysglycemia and Body Composition in Adults With Cystic Fibrosis-Related Diabetes

DINE
Start date: September 1, 2023
Phase: N/A
Study type: Interventional

This study will evalute the effect of a low glycemic load (LGL diet on dysglycemia, insulin requirements, DXA-derived body composition, gastrointestinal symptoms and quality of life measures in adults with cystic fibrosis-related diabetes (CFRD). We will use continuous glucose monitors (CGM) to assess the LGL diet both in a controlled setting (via a meal delivery company) and in free-living conditions.

NCT ID: NCT05568134 Recruiting - Cystic Fibrosis Clinical Trials

Alternate Measures of Glucose During OGTT Testing for CFRD

Start date: July 17, 2023
Phase:
Study type: Observational

Although early detection and treatment of cystic fibrosis-related diabetes (CFRD) can lead to significant clinical improvements and prolong life, rates of screening are poor likely due to the burdensome nature of oral glucose tolerance testing (OGTT). The investigators propose to assess the feasibility and accuracy of two screening tools, continuous glucose monitoring (CGM) and a home OGTT kit (GTT@home). If this pilot study reveals acceptable accuracy of either device, this study will allow for future studies exploring home-based OGTT screening.

NCT ID: NCT05562492 Recruiting - Clinical trials for Cystic Fibrosis-related Diabetes

Closed-loop for People Living With Cystic Fibrosis Related Diabetes

CL4P-CF
Start date: April 12, 2023
Phase: N/A
Study type: Interventional

The main objective of this study is to determine whether closed-loop glucose control is superior to standard insulin therapy with continuous glucose monitoring (CGM) in young people (≥16 years) and adults with cystic fibrosis (CF) related diabetes. This is an open-label, multicentre, randomised, single-period, two-arm parallel design study, involving a run-in period followed by a 26 week intervention period during which glucose levels will be controlled either by a hybrid closed-loop system or by participants usual insulin therapy with continuous glucose monitoring. A total of up to 128 young people and adults (aiming for 114 completed participants) with CF related diabetes using insulin will be recruited through outpatient CF and diabetes clinics and other established methods at participating centres. Participants who drop out of the study within the first 4 weeks of the intervention period will be replaced. Participants will receive appropriate training in the safe use of the CGM and closed-loop devices. Participants will have access to the study team during the intervention phase with 24/7 telephone support. The primary outcome is time spent in target range between 3.9 and 10.0 mmol/L as recorded by CGM over the 26 week period. Other key endpoints include time above target glucose range (>10mmol/L), mean glucose, and HbA1c. Secondary outcomes include time spent with glucose levels below target as recorded by CGM, and other CGM-based metrics in addition to percent of predicted FEV1, body mass index, fasting C-peptide levels, insulin requirements and number of pulmonary exacerbations and hospitalisations. Safety evaluation comprises severe hypoglycaemic episodes, and other adverse and serious adverse events. Psychosocial outcomes include CGM & closed-loop usage, health-related quality of life questionnaires, burden of diabetes management assessment and semi-structured interviews after participants have had at least three months experience of using the technology. Data will be collected for future health economic analysis.

NCT ID: NCT05463289 Recruiting - Type 2 Diabetes Clinical Trials

ACCESS 2: AI for pediatriC diabetiC Eye examS Study 2

ACCESS2
Start date: July 11, 2022
Phase: N/A
Study type: Interventional

The purpose of this study is to determine if use of a nonmydriatic fundus camera using autonomous artificial intelligence software at the point of care increases the proportion of underserved youth with diabetes screened for diabetic retinopathy.

NCT ID: NCT05377502 Recruiting - Cystic Fibrosis Clinical Trials

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.

Start date: December 15, 2021
Phase:
Study type: Observational

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.

NCT ID: NCT05229640 Withdrawn - Clinical trials for Cystic Fibrosis-related Diabetes

Relationship Between the Development of Impaired Glucose Tolerance, the Phenotype of CFLD, and the Risk of Liver Fibrosis

Start date: March 31, 2022
Phase: N/A
Study type: Interventional

This study proposes to examine the relationship between the development of impaired glucose tolerance, the phenotype of CFLD, and risk of liver fibrosis.