Glucose IntoleranceGluTolCFNCT02569229
Glucose Tolerance in Children With Cystic Fibrosis
An observational study of Glucose Intolerance and Cystic Fibrosis, run by Christoph Saner at 1 site in Switzerland.
Trial summary
The aim is to describe the association of glucose tolerance measured with three different tools (continuous glucose measurement system - CGMS, oral glucose tolerance testing - OGTT and optional intravenous glucose tolerance testing -IVGTT) with parameters out of lung function and anthropometric parameters in patients… Read more about this study
- Who is it for?
- Ages 10 to 20 years
- Conditions the study is for
- Glucose Intolerance, Cystic Fibrosis
- What is being tested?
- Diagnostics for glucose tolerance with 3 different methods.
- Type of treatment
- Pill or oral medicine, Injection or infusion
- How many people
- 14 participants
- Where
- 1 siteSwitzerland
- Study dates
- Jun 2015to 18 Nov 2016
- 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 20 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Patients with genetically determined cystic fibrosis.
Who may be able to join
- Patients with confirmed cystic fibrosis aged between 10-20 years, under medical treatment at the University Children's Hospital Basel UKBB and at the University Children's Hospital, Inselspital Bern
Who cannot join
- Patients being under medical treatment with systemically administered glucocorticoid drugs or intravenously administered antibiotic treatment within 6 weeks before glucose tolerance testing.
- Patients with acute pulmonary exacerbation, defined by a pediatric pneumologist
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Glucose Tolerance and Its Clinical Impact in Children and Adolescents With Cystic Fibrosis
The aim is to describe the association of glucose tolerance measured with three different tools (continuous glucose measurement system - CGMS, oral glucose tolerance testing - OGTT and optional intravenous glucose tolerance testing -IVGTT) with parameters out of lung function and anthropometric parameters in patients with cystic fibrosis.
Read the detailed description
Patients with cystic fibrosis (CF) with progressing disease are developing a glucose tolerance which resembles the metabolic state of a diabetic patient because of increasing impairment of endocrine pancreatic function. The prevalence of this diabetic metabolic state is increasing with age, reaching around 20% at the age of 20 years.
Over the last decade, research has already highlighted the negative influence of cystic fibrosis related diabetes (CFRD) on morbidity and mortality after the diagnosis of this condition.
As the deterioration in nutritional status and lung function can already be noticed 2-6 years before the onset of CFRD, the importance of early diagnosis in glucose abnormalities and its treatment therefore is crucial.
The currently used method to evaluate altered glucose metabolism in patients with CF is an annual oral glucose tolerance test (OGTT) with the glucose value after 120 min after oral ingestion of glucose-fluid as reference. This method may detect CFRD much later than we see deterioration of lung function and weight loss. This deterioration and the mortality in CF is related to CFRD.
An alternative diagnostic tool that has gained increasing attention and that is already routinely used in pediatric patients with diabetes mellitus type I is the continuous glucose monitoring system (CGMS) which was shown to be much more sensitive in detecting glucose abnormalities. To assess pancreatic endocrine dysfunction - the pathophysiologic cause for glucose intolerance - intravenous glucose tolerance testing (IVGTT) is the gold standard.
The investigator's aim is to describe the association of glucose tolerance measured with three different tools/assessment procedures (CGMS, OGTT and optional IVGTT) with lung function and anthropometric parameters.
- Conditions
- Glucose Intolerance, Cystic Fibrosis
- Being tested
- Diagnostics for glucose tolerance with 3 different methods.
- Keywords
- children, cystic fibrosis, glucose intolerance, continuous glucose measurement
- Medical subject headings
- Glucose Intolerance, Cystic Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diagnostics for glucose tolerance with 3 different methods.Other
- A 7-day course of subcutaneous continuous glucose monitoring system (CGMS).
- An oral glucose tolerance test done within the 7 day period of CGMS.
- Optionally a intravenous glucose tolerance test done within the 7 day period of CGMS.
| Study group | Role | What they receive |
|---|---|---|
| Patients with Cystic Fibrosis | Patients between 10-20 years of age with genetically determined cystic fibrosis followed at the university children's hospital Basel and university children's hospital Kinderklinik Bern, Switzerland. All patients will get the diagnostics for glucose tolerance with 3 different methods (CGMS, OGTT and optionally IVGTT). Receives: Other: Diagnostics for glucose tolerance with 3 different methods. |
What is being measured
The primary outcome is the main question the study is designed to answer.
% time spent above 8mmol/l, the area under the curve and the mean glucose value (in mmol/l)
These measurements will be gained out of the 7 day CGMS-course (continuous glucose monitoring system).
Measured: Beginning at day 1, lasting 7 days
The glucose values given in mmol/l after 30', 60', 90' and 120 minutes during OGTT.
Standard oral glucose tolerance test.
Measured: Within the 7 day course of CGMS
First phase insulin secretion and second phase insulin secretion out of IVGTT (intravenous glucose tolerance test).
Standard intravenous glucose tolerance test.
Measured: Within the 7 day course of CGMS
FEV1% (forced expiratory volume at one second) out of the lung function testing
Measured: Within 3 months of the 7 day course of CGMS
Lung clearance index
Measured: Within 3 months of the 7 day course of CGMS
BMI-SDS (standard deviation score).
Measured: At day 1 of the CGMS course
HbA1c
Measured: Within the 7 day course of CGMS
Secondary outcomes (1)
Comparing the performance between CGMS and OGTT related to clinical parameters.
The investigators compare the fit of a linear regression between the % time above 8mmol/l (out of CGMS) and the lung clearance index (LCI) with the fit of a linear regression of the 120min glucose value (out of OGTT) and the LCI. The same analysis will be performed comparing the fit of a regression between the % time above 8mmol/l (out of CGMS) and the FEV1% (out of lung function) with the fit of a linear regression of the 120min glucose value (out of OGTT) and the FEV1%. Finally, the same analysis will be performed comparing the fit of a linear regression using the % time above 8mmol/l (out of CGMS) and the BMI-SDS with the fit of a linear regression of the 120min glucose value (out of OGTT) and the BMI-SDS.
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2015 (estimated)
- Study startJun 2015
- Primary completion18 Nov 2016
- Study completion18 Nov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Glucose IntoleranceStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Christoph Saner
- Sponsor type
- University, hospital or other
- Collaborators
- Insel Gruppe AG, University Hospital Bern
- Responsible party
- Sponsor-investigator, Christoph Saner, University Hospital, Basel, Switzerland
- Investigators
- Christoph Saner, MD, Principal investigator, University childrens Hospital, UKBB, Basel SwitzerlandUrs Zumsteg, Prof, Study director, University childrens Hospital, UKBB, Basel Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02569229
- Sponsor's protocol ID
- EKNZ 2015-143
- Other IDs
- KEK BE: 102/15
- Acronym
- GluTolCF
- Status last verified
- Nov 2022
- First submitted
- 12 Aug 2015
- Last updated
- 21 Nov 2022
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Glucose Tolerance and Its Clinical Impact in Children and Adolescents With Cystic Fibrosis
- ClinicalTrials.gov ID
- NCT02569229
- Acronym / sponsor ID
- GluTolCF / EKNZ 2015-143
- Conditions
- Glucose Intolerance, Cystic Fibrosis
- Keywords
- children, cystic fibrosis, glucose intolerance, continuous glucose measurement
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Christoph SanerUniversity, hospital or other
- Collaborators
- Insel Gruppe AG, University Hospital Bern
- Study start
- Jun 2015
- Primary completion
- 18 Nov 2016 (actual)
- Study completion
- 18 Nov 2016 (actual)
- First posted
- 6 Oct 2015 (estimated)
- 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.
The aim is to describe the association of glucose tolerance measured with three different tools (continuous glucose measurement system - CGMS, oral glucose tolerance testing - OGTT and optional intravenous glucose tolerance testing -IVGTT) with parameters out of lung function and anthropometric parameters in patients with cystic fibrosis.
Detailed description
Patients with cystic fibrosis (CF) with progressing disease are developing a glucose tolerance which resembles the metabolic state of a diabetic patient because of increasing impairment of endocrine pancreatic function. The prevalence of this diabetic metabolic state is increasing with age, reaching around 20% at the age of 20 years.
Over the last decade, research has already highlighted the negative influence of cystic fibrosis related diabetes (CFRD) on morbidity and mortality after the diagnosis of this condition.
As the deterioration in nutritional status and lung function can already be noticed 2-6 years before the onset of CFRD, the importance of early diagnosis in glucose abnormalities and its treatment therefore is crucial.
The currently used method to evaluate altered glucose metabolism in patients with CF is an annual oral glucose tolerance test (OGTT) with the glucose value after 120 min after oral ingestion of glucose-fluid as reference. This method may detect CFRD much later than we see deterioration of lung function and weight loss. This deterioration and the mortality in CF is related to CFRD.
An alternative diagnostic tool that has gained increasing attention and that is already routinely used in pediatric patients with diabetes mellitus type I is the continuous glucose monitoring system (CGMS) which was shown to be much more sensitive in detecting glucose abnormalities. To assess pancreatic endocrine dysfunction - the pathophysiologic cause for glucose intolerance - intravenous glucose tolerance testing (IVGTT) is the gold standard.
The investigator's aim is to describe the association of glucose tolerance measured with three different tools/assessment procedures (CGMS, OGTT and optional IVGTT) with lung function and anthropometric parameters.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with Cystic Fibrosis | – | Other: Diagnostics for glucose tolerance with 3 different methods.Patients between 10-20 years of age with genetically determined cystic fibrosis followed at the university children's hospital Basel and university children's hospital Kinderklinik Bern, Switzerland. All patients will get the diagnostics for glucose tolerance with 3 different methods (CGMS, OGTT and optionally IVGTT). |
Who may qualify
- Ages
- 10 to 20 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Patients with genetically determined cystic fibrosis.
Key inclusion criteria (1 listed)
- Patients with confirmed cystic fibrosis aged between 10-20 years, under medical treatment at the University Children's Hospital Basel UKBB and at the University Children's Hospital, Inselspital Bern
Key exclusion criteria (2 listed)
- Patients being under medical treatment with systemically administered glucocorticoid drugs or intravenously administered antibiotic treatment within 6 weeks before glucose tolerance testing.
- Patients with acute pulmonary exacerbation, defined by a pediatric pneumologist
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 |
|---|---|---|
| Diagnostics for glucose tolerance with 3 different methods.1. A 7-day course of subcutaneous continuous glucose monitoring system (CGMS). 2. An oral glucose tolerance test done within the 7 day period of CGMS. 3. Optionally a intravenous glucose tolerance test done within the 7 day period of CGMS. | Other | Patients with Cystic Fibrosis |
Primary outcome
% time spent above 8mmol/l, the area under the curve and the mean glucose value (in mmol/l)
Time frame: Beginning at day 1, lasting 7 days
These measurements will be gained out of the 7 day CGMS-course (continuous glucose monitoring system).
The glucose values given in mmol/l after 30', 60', 90' and 120 minutes during OGTT.
Time frame: Within the 7 day course of CGMS
Standard oral glucose tolerance test.
First phase insulin secretion and second phase insulin secretion out of IVGTT (intravenous glucose tolerance test).
Time frame: Within the 7 day course of CGMS
Standard intravenous glucose tolerance test.
FEV1% (forced expiratory volume at one second) out of the lung function testing
Time frame: Within 3 months of the 7 day course of CGMS
Lung clearance index
Time frame: Within 3 months of the 7 day course of CGMS
BMI-SDS (standard deviation score).
Time frame: At day 1 of the CGMS course
HbA1c
Time frame: Within the 7 day course of CGMS
1 secondary outcome
Comparing the performance between CGMS and OGTT related to clinical parameters.
Time frame: 7 days
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 21 Nov 2022.
Related trials for Glucose Intolerance
Recruiting
Effects of Lean Pork Loin Intake on Protein Homeostasis and Glucose Regulation in Prediabetic Adults
Hyperglycaemia (Non Diabetic), Prediabetes
RecruitingObservational study
Food-i-Sense Analytics: Integrating AI Into Continuous Glucose Monitoring Data Analysis for Precision Nutrition.
Prediabetes (Insulin Resistance, Impaired Glucose Tolerance), Artificial Intelligence Mobile Application
Enrolling by invitationEarly Phase 1
Truway Diagnostic Tools in Primary Care
Chronic Disease, Type 2 Diabetes Mellitus (T2DM), Obesity, Overweight
Recruiting
CGM-Enhanced DPP to Prevent Type 2 Diabetes in Adults With Prediabetes
PreDiabetes
Active, not recruitingPhase 2
Extension Study to Evaluate the Safety of Long-Term Use of Relacorilant in Patients With Cushing Syndrome
Cushing Syndrome
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.
Christoph Saner, MD principal investigator
University childrens Hospital, UKBB, Basel Switzerland
Urs Zumsteg, Prof study director
University childrens Hospital, UKBB, Basel Switzerland
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 Glucose Intolerance and Cystic Fibrosis, run by Christoph Saner at 1 site in Switzerland.
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 1 inclusion and 2 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 21 Nov 2022. 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 Switzerland. 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?
% time spent above 8mmol/l, the area under the curve and the mean glucose value (in mmol/l) (time frame: Beginning at day 1, lasting 7 days). The study lists 7 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 21 Nov 2022.