Cystic Fibrosis-related DiabetesNCT03205904
Nutritional Intervention and Glycemic Improvement in Patients With Pre-diabetic Cystic Fibrosis.
A study testing Diet in people with Cystic Fibrosis-related Diabetes and Cystic Fibrosis, run by Hospital de Clinicas de Porto Alegre at 1 site in Brazil.
Trial summary
Cystic fibrosis (CF) is a genetic disease with an autosomal recessive, chronic and progressive character about 10 to 25% of patients develop CF-related diabetes (DRFC). Until now, there is no evidence to support the use of low glycemic index diet to improve glycemic response in pre-diabetic and CF patients. Read more about this study
- Who is it for?
- Ages 10 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cystic Fibrosis-related Diabetes, Cystic Fibrosis
- What is being tested?
- Diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteBrazil
- Study dates
- 12 Dec 2016to 20 Feb 2019
- Phase
- Interventional
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- tolerance glucose test values between 100 and 125mg / dl and or glucose 2h after 75g of glucose between 140 and 199 mg / dl
- Stable pulmonary disease in the last four weeks
Who cannot join
- Without hospitalization in the last 3 months
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Ticiana da Costa Rodrigues
Porto Alegre, Rio Grande do Sul, 90035-903
About this study
Cystic fibrosis (CF) is a genetic disease with an autosomal recessive, chronic and progressive character about 10 to 25% of patients develop CF-related diabetes (DRFC). Until now, there is no evidence to support the use of low glycemic index diet to improve glycemic response in pre-diabetic and CF patients. The objective of this study is to evaluate the glycemic improvement after nutritional orientation in patients with cystic fibrosis.
Read the detailed description
Cystic fibrosis (CF) is a genetic disease with an autosomal recessive, chronic and progressive character. About 10 to 25% of patients develop CF-related diabetes (DRFC), whose pathogenesis is associated with pancreatic fibrosis and destruction. Until now, there is no evidence to support the use of low glycemic index diet to improve glycemic response in pre-diabetic and CF patients. The objective of this study is to evaluate the glycemic improvement after nutritional orientation in patients with cystic fibrosis in the pre-diabetic phase. Methods: Randomized clinical trial in patients with CF aged over 10 years without hospitalization in the last 4 weeks. Anthropometric measurements, blood pressure, 24 hour recall and food frequency questionnaire will be evaluated. Oral glucose tolerance and glycated hemoglobin test will be dosed at baseline and during 12 weeks of follow-up. The intervention group will receive a nutritional guidance at the beginning of the research.
- Conditions
- Cystic Fibrosis-related Diabetes, Cystic Fibrosis
- Being tested
- Diet
- Keywords
- cystic fibrosis related diabetes
- Medical subject headings
- Cystic Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DietDietary supplement
Nutrition booklet with guidelines on types of fats and glycemic index
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Active comparator | Group that will be receive the diet Receives: Dietary Supplement: Diet |
| control | No intervention | Group that will not receive the diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
glycemic improvement after nutritional orientation in patients with cystic fibrosis in the pre-diabetic phase
To evaluate the improvement of glucose levels after the diet intervention. After 12 weeks of intervention will be performed oral glucose tolerance test
Measured: 3 months
Secondary outcomes (3)
Evaluate the levels of HbA1c before and after the intervention
Evaluate the levels of HbA1c before and after the intervention
Measured: 3 months
Evaluate the response of forced expiratory volume and forced vital capacity before and after the intervention
Evaluate the response of FEV 1 (forced expiratory volume) before and after the intervention
Measured: 3 months
To evaluate anthropometric data of the patients before and after the intervention.
Improvement of nutritional status Using weight (kg) and height (cm) and BMI.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2017
- Study start12 Dec 2016
- Primary completion20 Feb 2019
- Study completion20 Feb 2019
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.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital de Clinicas de Porto Alegre
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ticiana C Rodrigues, Doctor, Principal investigator, Hospital de Clinicas de Porto Alegre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03205904
- Sponsor's protocol ID
- 160206
- Status last verified
- Jan 2021
- First submitted
- 15 Jun 2017
- Last updated
- 13 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nutritional Intervention and Glycemic Improvement in Patients With Pre-diabetic Cystic Fibrosis.
- ClinicalTrials.gov ID
- NCT03205904
- Acronym / sponsor ID
- 160206
- Conditions
- Cystic Fibrosis-related Diabetes, Cystic Fibrosis
- Keywords
- cystic fibrosis related diabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Hospital de Clinicas de Porto AlegreUniversity, hospital or other
- Study start
- 12 Dec 2016 (actual)
- Primary completion
- 20 Feb 2019 (actual)
- Study completion
- 20 Feb 2019 (actual)
- First posted
- 2 Jul 2017 (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 a genetic disease with an autosomal recessive, chronic and progressive character about 10 to 25% of patients develop CF-related diabetes (DRFC). Until now, there is no evidence to support the use of low glycemic index diet to improve glycemic response in pre-diabetic and CF patients. The objective of this study is to evaluate the glycemic improvement after nutritional orientation in patients with cystic fibrosis.
Detailed description
Cystic fibrosis (CF) is a genetic disease with an autosomal recessive, chronic and progressive character. About 10 to 25% of patients develop CF-related diabetes (DRFC), whose pathogenesis is associated with pancreatic fibrosis and destruction. Until now, there is no evidence to support the use of low glycemic index diet to improve glycemic response in pre-diabetic and CF patients. The objective of this study is to evaluate the glycemic improvement after nutritional orientation in patients with cystic fibrosis in the pre-diabetic phase. Methods: Randomized clinical trial in patients with CF aged over 10 years without hospitalization in the last 4 weeks. Anthropometric measurements, blood pressure, 24 hour recall and food frequency questionnaire will be evaluated. Oral glucose tolerance and glycated hemoglobin test will be dosed at baseline and during 12 weeks of follow-up. The intervention group will receive a nutritional guidance at the beginning of the research.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Active comparator | Dietary Supplement: DietGroup that will be receive the diet |
| control | No intervention | –Group that will not receive the diet |
Who may qualify
- Ages
- 10 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- tolerance glucose test values between 100 and 125mg / dl and or glucose 2h after 75g of glucose between 140 and 199 mg / dl
- Stable pulmonary disease in the last four weeks
Key exclusion criteria (1 listed)
- Without hospitalization in the last 3 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DietNutrition booklet with guidelines on types of fats and glycemic index | Dietary supplement | Intervention group |
Primary outcome
glycemic improvement after nutritional orientation in patients with cystic fibrosis in the pre-diabetic phase
Time frame: 3 months
To evaluate the improvement of glucose levels after the diet intervention. After 12 weeks of intervention will be performed oral glucose tolerance test
3 secondary outcomes
Evaluate the levels of HbA1c before and after the intervention
Time frame: 3 months
Evaluate the response of forced expiratory volume and forced vital capacity before and after the intervention
Time frame: 3 months
To evaluate anthropometric data of the patients before and after the intervention.
Time frame: 3 months
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 13 Jan 2021.
- Individual participant dataSharing planned: No
Related trials for Cystic Fibrosis-related Diabetes
Recruiting
ACCESS 2: AI for pediatriC diabetiC Eye examS Study 2
Type 1 Diabetes, Type 2 Diabetes
Active, not recruitingPhase 2/3
SGLT2 Inhibitor Therapy in Cystic Fibrosis-related Diabetes
Cystic Fibrosis-related Diabetes, Cystic Fibrosis
Active, not recruitingPhase 3
Bionic Pancreas in CFRD
Cystic Fibrosis-related Diabetes
RecruitingPhase 1
Dorzagliatin in Pancreatic Insufficient Cystic Fibrosis
Pancreatic Insufficiency, Cystic Fibrosis-related Diabetes
RecruitingObservational study
Hormonal Responses to a Mixed Meal in People With Cystic Fibrosis
Cystic Fibrosis
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.
Ticiana C Rodrigues, Doctor principal investigator
Hospital de Clinicas de Porto Alegre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Diet in people with Cystic Fibrosis-related Diabetes and Cystic Fibrosis, run by Hospital de Clinicas de Porto Alegre at 1 site in Brazil.
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 2 inclusion and 1 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 13 Jan 2021. 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 Brazil. 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?
glycemic improvement after nutritional orientation in patients with cystic fibrosis in the pre-diabetic phase (time frame: 3 months). 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 13 Jan 2021.