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

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.

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

Study Overview

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

Detailed Description

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

• Study Type: Observational
• Enrollment (Actual): 40

Contacts and Locations

Study Locations

• Turkey
  • Ankara, Turkey, 06230
    • Elif Kocaaga

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 10 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

cystic fibrosis with (impaired glucose tolerance, cystic fibrosis related diabetes) and without abnormal glucose tolerance

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
cystic fibrosis with abnormal glucose tolerance; cystic fibrosis with abnormal glucose tolerance Cystic fibrosis patients with descripted that impaired glucose tolerance or cystic fibrosis related diabetes by oral glucose tolerance test
cystic fibrosis with normal glucose tolerance; cystic fibrosis with normal glucose tolerance Cystic fibrosis patients with descripted that normal glucose tolerance by oral glucose tolerance test

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Lung function	Lung function will be assesed for standardization procedure in Cystic fibrosis. Acceptible outcome will be recorded.	28 week
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
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
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
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
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
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
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

Collaborators and Investigators

• Sponsor: Hacettepe University

Study record dates

Study Major Dates

• Study Start (Actual): September 13, 2019
• Primary Completion (Actual): March 11, 2020
• Study Completion (Actual): March 11, 2020

Study Registration Dates

• First Submitted: April 7, 2020
• First Submitted That Met QC Criteria: August 4, 2020
• First Posted (Actual): August 7, 2020

Study Record Updates

• Last Update Posted (Actual): August 7, 2020
• Last Update Submitted That Met QC Criteria: August 4, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Keywords: Physical fitness; Cystic fibrosis; Muscle strength; Glucose
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Glucose Metabolism Disorders; Metabolic Diseases; Respiratory Tract Diseases; Lung Diseases; Endocrine System Diseases; Infant, Newborn, Diseases; Genetic Diseases, Inborn; Pancreatic Diseases; Fibrosis; Diabetes Mellitus; Cystic Fibrosis
• Other Study ID Numbers: GO19/704

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No