A Comparison of Clinical Parameters in With and Without Abnormal Glucose Tolerance.

Completed

• Conditions: Diabetes Mellitus; Cystic Fibrosis; Cystic Fibrosis-related Diabetes

• Registration Number: NCT04503408
• Lead Sponsor: Hacettepe University

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2019-09-13
• Primary Completion: 2020-03-11
• Study Completion: 2020-03-11
• Study First Submitted: 2020-04-07
• Status Verified: 2020-08
• Study First Submitted QC: 2020-08-04
• Last Update Submitted: 2020-08-04
• Study First Posted: 2020-08-07
• Last Update Posted: 2020-08-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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.

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Physical fitness	28 week	Physical fitness is measured with Munich physical fitness test battery. This battery vertial jump, bouncing ball, flexibilty, climbing, throwing bag, step up test are included in battery. the battery evaluates such as strength, endurance, speed, flexibilty, coordination, power.
Quadriceps muscle strength	28 week	Quadriceps muscle strength will be assessed least three times in children with cystic fibrosis. hand held dynamometer will be used for assessing quadriceps muscle strength. The highest value for each side will be recorded and used for analysis.
Handgrip	28 week	Handgrip will be assessed in Cystic fibrosis using hand dynamometer (Jamar hand dynamometer). Assessing will be repeated three times end mean of three measurement will be calculated and used for analysis.
Distance of shuttle walk test	28 week	Distance of shuttle walk test will be walked by children with cystic fibrosis. Shuttle walk test is made on floor with ten meters distance. Speed is determined according to signals from CD player.
Distance of 6 minute walk test	28 week	Distance of 6 minute walk test assesing functional capacity made on flat corridor with speed is determined from participant. She/he walks during 6 minute on this corridor as quickly as possible.
Respiratory muscle strength	28 week	Both inspiratory and expiratory muscle strength wil be evaluated at least three times in Cystic fibrosis. Mouth pressure device will be used for evaluate. The highest value for MIP and MEP will be recorded.
Physical activity levels	28 week	Physical activity will be evaluated with Bouchard physical activity record. This activity recorder is evaluated every 15 min in a day. Two weekday and one weekend day are recorded with made activity.
Lung function	28 week	Lung function will be assesed for standardization procedure in Cystic fibrosis. Acceptible outcome will be recorded.
Time of activities of daily living test	28 week	Activities of daily living will be tested with the Glittre ADL test. This test includes five repeated cycles that includes sitting, walk, step up and changing place of object on bookshelf in test procedure. The total completion time of five cycles will be recorded and used for analysis

Trial Locations

Locations (1)

Elif Kocaaga; 🇹🇷 Ankara, Turkey