Cystic Fibrosis-related DiabetesNCT04503408
A Comparison of Clinical Parameters in With and Without Abnormal Glucose Tolerance.
An observational study of Cystic Fibrosis-related Diabetes and Diabetes Mellitus, run by Hacettepe University at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 10 to 18 years
- Conditions the study is for
- Cystic Fibrosis-related Diabetes, Diabetes Mellitus, Cystic Fibrosis
- Type of treatment
- Pill or oral medicine
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 13 Sep 2019to 11 Mar 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: cystic fibrosis with (impaired glucose tolerance, cystic fibrosis related diabetes) and without abnormal glucose tolerance
Who may be able to join
- Cystic fibrosis with impaired glucose tolerance or cystic fibrosis-related diabetes for Abnormal glucose tolerance group
- Cooperation for tests
- Indıviduals without an orthopedic or neurological problem and serious cardiac problems that effecting tests,
- To volunteer for the study.
- For the control group
- Cystic fibrosis with normal glucose tolerance
Show all 9Show fewer
- Cooperation for tests
- Indıviduals without an orthopedic or neurological problem and serious cardiac problems that effecting tests,
- To volunteer for the study.
Who cannot join
- Patients having following disease
- Acute pulmonary exacerbation
- Acute or chronic respiratory failure
- FEV₁ lower than %40
- Cooperation problems,
- Bronchopulmonary aspergillus and using steroid.
Trial locations and contacts
1 site in 1 country.
About this study
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.
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
Read the detailed description
The study aimed that comparison of clinical parameters in children with and without abnormal glucose tolerance in Cystic fibrosis.
- Keywords
- Glucose, Cystic fibrosis, Muscle strength, Physical fitness
- Medical subject headings
- Diabetes Mellitus, Cystic Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 28 week
Lung function
Lung function will be assesed for standardization procedure in Cystic fibrosis. Acceptible outcome will be recorded.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 28 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2020
- Study start13 Sep 2019
- Primary completion11 Mar 2020
- Study completion11 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cystic Fibrosis-related DiabetesStudies of the same condition, open and under way.
- More trials run by Hacettepe UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elif Kocaaga, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04503408
- Sponsor's protocol ID
- GO19/704
- Status last verified
- Aug 2020
- First submitted
- 7 Apr 2020
- Last updated
- 7 Aug 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT04503408
- Acronym / sponsor ID
- GO19/704
- Keywords
- Glucose, Cystic fibrosis, Muscle strength, Physical fitness
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 13 Sep 2019 (actual)
- Primary completion
- 11 Mar 2020 (actual)
- Study completion
- 11 Mar 2020 (actual)
- First posted
- 7 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 10 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- cystic fibrosis with (impaired glucose tolerance, cystic fibrosis related diabetes) and without abnormal glucose tolerance
Key inclusion criteria (9 listed)
- Cystic fibrosis with impaired glucose tolerance or cystic fibrosis-related diabetes for Abnormal glucose tolerance group
- Cooperation for tests
- Indıviduals without an orthopedic or neurological problem and serious cardiac problems that effecting tests,
- To volunteer for the study.
- For the control group
Key exclusion criteria (6 listed)
- Patients having following disease
- Acute pulmonary exacerbation
- Acute or chronic respiratory failure
- FEV₁ lower than %40
- Cooperation problems,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Distance of 6 minute walk test
Time frame: 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.
Lung function
Time frame: 28 week
Lung function will be assesed for standardization procedure in Cystic fibrosis. Acceptible outcome will be recorded.
Respiratory muscle strength
Time frame: 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.
Quadriceps muscle strength
Time frame: 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
Time frame: 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.
Physical activity levels
Time frame: 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.
Physical fitness
Time frame: 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.
Distance of shuttle walk test
Time frame: 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.
Time of activities of daily living test
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cystic Fibrosis-related Diabetes and Diabetes Mellitus, run by Hacettepe University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Distance of 6 minute walk test (time frame: 28 week). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2020.