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

Diabetes Mellitus Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04503408
• Other study ID #: GO19/704
• Status: Completed
• Start date: September 13, 2019
• Est. completion date: March 11, 2020

Study information

• Verified date: August 2020
• Source: Hacettepe University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: March 11, 2020
• Est. primary completion date: March 11, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 10 Years to 18 Years

Eligibility

Inclusion Criteria:

1. Cystic fibrosis with impaired glucose tolerance or cystic fibrosis-related diabetes for Abnormal glucose tolerance group

2. Cooperation for tests

3. Individuals 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. Individuals 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.

Related Conditions & MeSH terms

• Cystic Fibrosis
• Cystic Fibrosis-related Diabetes
• Diabetes Mellitus
• Fibrosis
• Glucose Intolerance

Locations

Country	Name	City	State
Turkey	Elif Kocaaga	Ankara

Sponsors (1)

Lead Sponsor	Collaborator
Hacettepe University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Distance of 6 minute walk test	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.	28 week
Primary	Lung function	Lung function will be assesed for standardization procedure in Cystic fibrosis. Acceptible outcome will be recorded.	28 week
Primary	Respiratory muscle strength	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.	28 week
Primary	Quadriceps muscle strength	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.	28 week
Primary	Handgrip	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.	28 week
Primary	Physical activity levels	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.	28 week
Primary	Physical fitness	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.	28 week
Primary	Distance of shuttle walk test	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.	28 week
Primary	Time of activities of daily living test	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	28 week