Clinical trial NCT04503408: A Comparison of Clinical Parameters in With and Without Abnormal Glucose Tolerance.
Official title: A Comparison of Pulmonary Function, Functional Capacity, Muscle Strength, Physical Activity, Physical Fitness and Activities of Daily Living in Cystic Fibrosis Patient's With and Without Abnormal Glucose Tolerance.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cystic Fibrosis-related Diabetes
Diabetes Mellitus
Cystic Fibrosis
Keywords: Glucose
Cystic fibrosis
Muscle strength
Physical fitness
Lead sponsor: Hacettepe University
Sponsor class: OTHER
First posted: 2020-08-07
Enrollment: 40
Sex: ALL
Minimum age (years): 10
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: cystic fibrosis with (impaired glucose tolerance, cystic fibrosis related diabetes) and without abnormal glucose tolerance

Brief summary: Cystic fibrosis (CF) is autosomal recessive, genetic disorder cause of cystic fibrosis transmembrane regulatory (CFTR) gene mutation. CF often is observed in caucasian population. CFTR protein in cell apical membrane is canal responsible of transport sodium and clorid ions. Impaired sodium ion transport causes production viscous mucus. Disease include problems such as mucus, breathlessness and coughing. Blood glucose levels fluctuation are observed. This study aims comparison between lung function, functional capacity, muscle strength, physical activity, physical fitness and activities of daily living activities in cystic fibrosis with and without abnormal glucose tolerance

Detailed description: The study aimed that comparison of clinical parameters in children with and without abnormal glucose tolerance in Cystic fibrosis.

Eligibility criteria: Inclusion Criteria:

1. Cystic fibrosis with impaired glucose tolerance or cystic fibrosis-related diabetes for Abnormal glucose tolerance group
2. Cooperation for tests
3. Indıviduals without an orthopedic or neurological problem and serious cardiac problems that effecting tests,
4. To volunteer for the study.

For the control group

1. Cystic fibrosis with normal glucose tolerance
2. Cooperation for tests
3. Indıviduals without an orthopedic or neurological problem and serious cardiac problems that effecting tests,
4. To volunteer for the study.

Exclusion Criteria:

Patients having following disease

1. Acute pulmonary exacerbation
2. Acute or chronic respiratory failure
3. FEV₁ lower than %40
4. Cooperation problems,
5. Bronchopulmonary aspergillus and using steroid.

Primary outcomes:
measure: Distance of 6 minute walk test
timeFrame: 28 week
measure: Lung function
timeFrame: 28 week
measure: Respiratory muscle strength
timeFrame: 28 week
measure: Quadriceps muscle strength
timeFrame: 28 week
measure: Handgrip
timeFrame: 28 week
measure: Physical activity levels
timeFrame: 28 week
measure: Physical fitness
timeFrame: 28 week
measure: Distance of shuttle walk test
timeFrame: 28 week
measure: Time of activities of daily living test
timeFrame: 28 week
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Elif Kocaaga
Study officials:
References: