Cystic Fibrosis Related DiabetesNCT00763412
Pilot and Feasibility Study for the Treatment of Pre-diabetes in Patients With Cystic Fibrosis
A study testing repaglinide in people with Cystic Fibrosis Related Diabetes and Pancreatic Insufficiency, run by Arbelaez, Ana Maria at 1 site in United States.
Trial summary
The purpose of this study is to provide the necessary data and experience to design a larger, full scale clinical trial to determine if a certain medicine (repaglinide), which increases the amount of insulin secreted by the pancreas, can improve the nutritional status and pulmonary function of adolescents and young… Read more about this study
- Who is it for?
- Ages 12 to 24 years
- Conditions the study is for
- Cystic Fibrosis Related Diabetes, Pancreatic Insufficiency
- What is being tested?
- repaglinide
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 31 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2006to Jan 2013
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 12 to 24 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Male or females 12 -24 years old
- Diagnosis of Cystic Fibrosis by sweat test with exocrine pancreatic insufficiency
- Must have a glucose pattern by Oral Glucose Tolerance Test with fasting blood glucose <126 mg/dl and 2 hour: 140 - 199 mg/dl or >200 mg/dl.
- Weight must be stable within 5% for 3 months prior to initiation visit
- Must be able to reproducibly perform spirometry based on American Thoracic Society guidelines
Who cannot join
- Patients receiving growth hormone therapy or taking insulin
- Patients with evidence of liver dysfunction
- Patients who are status-post lung or liver transplantation
- Patients who have received systemic steroids for more than 28 days during the 6 months prior to the study
- Patients with active ABPA on steroids
- Patients taking medications that affect glucose metabolism or contraindicated with repaglinide
Trial locations and contacts
1 site in 1 country.
United States1 site
Washington University School of Medicine
St Louis, Missouri, 63110
About this study
The purpose of this study is to provide the necessary data and experience to design a larger, full scale clinical trial to determine if a certain medicine (repaglinide), which increases the amount of insulin secreted by the pancreas, can improve the nutritional status and pulmonary function of adolescents and young adults with cystic fibrosis and prediabetes by improving blood glucose control. The investigators are also trying to determine the relationship between systemic inflammatory factors and glucose impairment.
Read the detailed description
As people with Cystic Fibrosis (CF) are living well into adulthood new complications are arising. CF-Related Diabetes (CFRD) has emerged as a major complication. Years prior to the diagnosis of CFRD, patients have decreasing insulin secretion, glucose intolerance, deteriorating pulmonary function, and nutritional impairment. There are no current standard recommendations for the treatment of CF patients with prediabetes, and there is little evidence that treatment of this prediabetic state in CF patients will prevent the deterioration of the lung function, nutritional status and potentially slow the progression to manifest CFRD.
To determine the feasibility of testing this hypothesis, we will perform a pilot, double-blinded, randomized controlled trial in 20 CF pancreatic insufficient patients ages of 12 to 24 years old with impaired glucose tolerance test (IGT) or CFRD without fasting hyperglycemia (CFRD-No FH) and assign them to either placebo or Repaglinide 0.5 mg PO 3 - 4 times a day before meals for two years. Patients will monitor their blood glucose daily and will be followed every 3 months for 2 years to determine changes in nutritional status by BMI and DEXA, lung function tests, frequency of hospitalizations, antibiotic courses, and degree of glucose tolerance, insulin secretion and insulin sensitivity.
In addition, based on the evidence of increased inflammation in type 2 diabetes, correlation of systemic inflammatory response at different degrees of glucose tolerance and after treatment, will be assessed in these subjects, as well as in another 20 CF pancreatic insufficient matched patients with normal glucose tolerance who will be studied once without intervention
- Being tested
- placebo, repaglinide
- Keywords
- Cystic Fibrosis, Diabetes, Cystic Fibrosis Related Diabetes, Pre-diabetes, oral hypoglycemic agents, Repaglinide, treatment, inflammatory markers, Lung function, nutrition
- Medical subject headings
- Exocrine Pancreatic Insufficiency, Cystic Fibrosis, Diabetes Mellitus, Glucose Intolerance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
placeboDrug
CF pancreatic insufficient patients with impaired glucose tolerance (IGT) or CFRD without fasting hyperglycemia (CFRD-No FH) by OGTT will be treated with placebo by taking 1 pill before each meal that contains more than 20 grams of carbohydrate 3-4 times a day for 2 years.
repaglinideDrug
Also called Prandin
CF pancreatic insufficient patients with impaired glucose tolerance (IGT) or CFRD without fasting hyperglycemia (CFRD-No FH) by OGTT will be treated with repaglinide 0.5 mg before each meal that contains more than 20 grams of carbohydrate 3-4 times a day for 2 years.
| Study group | Role | What they receive |
|---|---|---|
| 1 Placebo | Placebo comparator | 1 pill before each meal 3-4 times a day for 2 years. All subjects had abnormal glucose tolerance. Subjects were randomized to placebo or drug. Receives: Drug: placebo |
| 2. repaglinide | Experimental | repaglinide 0.5 mg before each meal 3-4 times a day for 2 years. All subjects had abnormal glucose tolerance.Subjects were randomized to placebo or drug. Receives: Drug: repaglinide |
What is being measured
The primary outcome is the main question the study is designed to answer.
BMI
Measured: 2 year/end of study
Body Composition
Reporting % of Fat and Lean body mass
Measured: 2 year/end of study
CRP
Measured: 2 year/end of study
Secondary outcomes (6)
Glucose Tolerance
We completed the OGTT at the 2 year/end of study visit.
Measured: 2-year
Inflammatory Markers
Measured: 2 year/end of study
Wt Z Score
Measured: 2 year/end of study
Tanner Stage
Puberty scale measuring 1-5, 1 being least development, 5 being most development.
Measured: 2 year/end of study
FEV 1
% of lung function
Measured: 2 year/end of study
C-Peptide
Measured: 2 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2008 (estimated)
- Study startNov 2006
- Primary completionJan 2013
- Study completionJan 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Arbelaez, Ana Maria
- Collaborators
- Washington University School of Medicine, National Institutes of Health (NIH), Novo Nordisk A/S, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Responsible party
- Principal investigator, Ana Maria Arbelaez, Arbelaez, Ana Maria
- Investigators
- Neil H White, M.D., Study chair, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00763412
- Sponsor's protocol ID
- 05-1109
- Other IDs
- P60DK020579
- Status last verified
- May 2017
- First submitted
- 29 Sep 2008
- Last updated
- 5 Jun 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The outcome was inconclusive for this hypothesis, but the data may be valuable in future research. We are not currently sharing data from this project.
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot and Feasibility Study for the Treatment of Pre-diabetes in Patients With Cystic Fibrosis
- ClinicalTrials.gov ID
- NCT00763412
- Acronym / sponsor ID
- 05-1109
- Keywords
- Cystic Fibrosis, Diabetes, Cystic Fibrosis Related Diabetes, Pre-diabetes, oral hypoglycemic agents, Repaglinide, treatment, inflammatory markers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Arbelaez, Ana Maria
- Collaborators
- Washington University School of Medicine, National Institutes of Health (NIH), Novo Nordisk A/S, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- Nov 2006
- Primary completion
- Jan 2013 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 1 Oct 2008 (estimated)
- Results
- Posted 5 Jun 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to provide the necessary data and experience to design a larger, full scale clinical trial to determine if a certain medicine (repaglinide), which increases the amount of insulin secreted by the pancreas, can improve the nutritional status and pulmonary function of adolescents and young adults with cystic fibrosis and prediabetes by improving blood glucose control. The investigators are also trying to determine the relationship between systemic inflammatory factors and glucose impairment.
Detailed description
As people with Cystic Fibrosis (CF) are living well into adulthood new complications are arising. CF-Related Diabetes (CFRD) has emerged as a major complication. Years prior to the diagnosis of CFRD, patients have decreasing insulin secretion, glucose intolerance, deteriorating pulmonary function, and nutritional impairment. There are no current standard recommendations for the treatment of CF patients with prediabetes, and there is little evidence that treatment of this prediabetic state in CF patients will prevent the deterioration of the lung function, nutritional status and potentially slow the progression to manifest CFRD.
To determine the feasibility of testing this hypothesis, we will perform a pilot, double-blinded, randomized controlled trial in 20 CF pancreatic insufficient patients ages of 12 to 24 years old with impaired glucose tolerance test (IGT) or CFRD without fasting hyperglycemia (CFRD-No FH) and assign them to either placebo or Repaglinide 0.5 mg PO 3 - 4 times a day before meals for two years. Patients will monitor their blood glucose daily and will be followed every 3 months for 2 years to determine changes in nutritional status by BMI and DEXA, lung function tests, frequency of hospitalizations, antibiotic courses, and degree of glucose tolerance, insulin secretion and insulin sensitivity.
In addition, based on the evidence of increased inflammation in type 2 diabetes, correlation of systemic inflammatory response at different degrees of glucose tolerance and after treatment, will be assessed in these subjects, as well as in another 20 CF pancreatic insufficient matched patients with normal glucose tolerance who will be studied once without intervention
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 Placebo | Placebo comparator | Drug: placebo1 pill before each meal 3-4 times a day for 2 years. All subjects had abnormal glucose tolerance. Subjects were randomized to placebo or drug. |
| 2. repaglinide | Experimental | Drug: repagliniderepaglinide 0.5 mg before each meal 3-4 times a day for 2 years. All subjects had abnormal glucose tolerance.Subjects were randomized to placebo or drug. |
Who may qualify
- Ages
- 12 to 24 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Male or females 12 -24 years old
- Diagnosis of Cystic Fibrosis by sweat test with exocrine pancreatic insufficiency
- Must have a glucose pattern by Oral Glucose Tolerance Test with fasting blood glucose <126 mg/dl and 2 hour: 140 - 199 mg/dl or >200 mg/dl.
- Weight must be stable within 5% for 3 months prior to initiation visit
- Must be able to reproducibly perform spirometry based on American Thoracic Society guidelines
Key exclusion criteria (6 listed)
- Patients receiving growth hormone therapy or taking insulin
- Patients with evidence of liver dysfunction
- Patients who are status-post lung or liver transplantation
- Patients who have received systemic steroids for more than 28 days during the 6 months prior to the study
- Patients with active ABPA on steroids
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 |
|---|---|---|
| placeboCF pancreatic insufficient patients with impaired glucose tolerance (IGT) or CFRD without fasting hyperglycemia (CFRD-No FH) by OGTT will be treated with placebo by taking 1 pill before each meal that contains more than 20 grams of carbohydrate 3-4 times a day for 2 years. | Drug | 1 Placebo |
| repaglinideAlso: PrandinCF pancreatic insufficient patients with impaired glucose tolerance (IGT) or CFRD without fasting hyperglycemia (CFRD-No FH) by OGTT will be treated with repaglinide 0.5 mg before each meal that contains more than 20 grams of carbohydrate 3-4 times a day for 2 years. | Drug | 2. repaglinide |
Primary outcome
BMI
Time frame: 2 year/end of study
Body Composition
Time frame: 2 year/end of study
Reporting % of Fat and Lean body mass
CRP
Time frame: 2 year/end of study
6 secondary outcomes
Glucose Tolerance
Time frame: 2-year
Inflammatory Markers
Time frame: 2 year/end of study
Wt Z Score
Time frame: 2 year/end of study
Tanner Stage
Time frame: 2 year/end of study
FEV 1
Time frame: 2 year/end of study
C-Peptide
Time frame: 2 year
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided. The outcome was inconclusive for this hypothesis, but the data may be valuable in future research. We are not currently sharing data from this project.
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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.
Neil H White, M.D. study chair
Washington University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing repaglinide in people with Cystic Fibrosis Related Diabetes and Pancreatic Insufficiency, run by Arbelaez, Ana Maria at 1 site in United States.
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 5 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 5 Jun 2017. 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 United States. 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. Some participants in this study may receive a placebo. 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?
Yes. Results are posted in the registry (first posted 5 Jun 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
BMI (time frame: 2 year/end of study). The study lists 3 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 5 Jun 2017.