Cystic FibrosisNCT02239458
DPP-IV Inhibition Prior to Development of Diabetes in Patients With Cystic Fibrosis
A study testing Saxagliptin in people with Cystic Fibrosis, run by Ram Weiss at 1 site in Israel.
Trial summary
Cystic fibrosis related diabetes (CFRD) is a common co-morbidity in patients with CF. The underlying pathophysiology of cystic fibrosis related diabetes (CFRD) is still a matter of investigation. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Cystic Fibrosis
- What is being tested?
- Saxagliptin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteIsrael
- Study dates
- Jun 2015to Jun 2016
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age greater than 18 years
- Diagnosis of CF
- No CFRD on baseline OGTT
- Normal kidney function
- No history of pancreatitis
- Able and willing to consent and participate
Who cannot join
- Acute illness/exacerbation of CF associated lung disease
- Receiving immune-modulators following lung/pancreas transplant
Trial locations and contacts
1 site in 1 country.
Israel1 site
Hadassah Ein Kerem/Har Hazofim
Jerusalem, 91120
Ram Weiss, MD PhD, ramw@ekmd.huji.ac.il
Eitan Kerem, MD
About this study
Cystic fibrosis related diabetes (CFRD) is a common co-morbidity in patients with CF. The underlying pathophysiology of cystic fibrosis related diabetes (CFRD) is still a matter of investigation. In addition to localized tissue damage developing similar to that of the exocrine pancreas, other mechanisms may be involved. We have shown that a potential contributing factor to the patho-physiology of CFRD may be an abnormal gut derived hormonal profile, specifically of lower incretin hormone responses, prior to development of CFRD.
We propose that an altered incretin response, probably due to impaired interaction of nutrients with the gut mucosa due to thickened secretions, may play a role in the development of the disease. Specifically, low GIP and GLP-1, may explain the poor β-cell function observed in these patients prior to CFRD appearance. These incretins have known trophic effects on β-cells, and thus their lower levels may contribute to the development of quantitative as well as qualitative defects in β-cell function and thus may lead to the development of CFRD. Thus, increasing levels of these incretins using a DPP-IV inhibitor may improve glucose metabolism and delay/prevent the development of CFRD.
We hypothesize that Saxagliptin will increase the oDI compared to placebo and will thus provide relative protection from diabetes development and in addition we expect that Saxagliptin will lead to overall increased insulin concentrations and thus shift the metabolic milieu to a more anabolic state. This will manifest as weight gain and reduction in inflammation.
Read the detailed description
The following proposal includes testing the utility of DPP-IV inhibition in adult patients with CF without CFRD. This will be achieved by a randomized double blind controlled trial of Saxagliptin 5 mg vs. placebo which will be performed for 3 months in 60 patients with CF without CFRD. The study will be for 3 months of use and will consist of two arms:
- Saxagliptin 5mg
- Placebo. the primary outcome of this study will be the oral disposition index oDI , derived from the OGTT. The oDI has been shown across age groups and metabolic phenotypes to be an excellent predictor of diabetes development over time . We postulate that Saxagliptin will increase incretin concentrations and thus improve insulin secretion. This will manifest as an increased oral disposition index (oDI), reflecting an improved beta cell response in the context of prevailing insulin sensitivity. The oDI is a useful predictor of diabetes development over time and its increase will provide evidence for protection from diabetes in this special study population
- Conditions
- Cystic Fibrosis
- Being tested
- Saxagliptin
- Medical subject headings
- Cystic Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SaxagliptinDrug
Also called Onglyza
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Placebo intake during 3 months |
| Saxagliptin 5mg | Active comparator | Saxagliptin dose of 5mg for 3 months Receives: Drug: Saxagliptin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oral Disposition Index
The oDI is a useful predictor of diabetes development over time and its increase will provide evidence for protection from diabetes in this special study population
Measured: The ODI will be calculated at baseline (Day 1) and at End point (day 90- 3 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2014 (estimated)
- Study startJun 2015
- Primary completionJun 2016 (estimated)
- Study completionJun 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cystic FibrosisStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ram Weiss
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ram Weiss, Hadassah Medical Organization
- Investigators
- Eitan Kerem, MD, Principal investigator, Hadassah Ein Kerem
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02239458
- Sponsor's protocol ID
- 0388-14-HMO
- Status last verified
- Sep 2014
- First submitted
- 8 Sep 2014
- Last updated
- 16 Apr 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- DPP-IV Inhibition Prior to Development of Diabetes in Patients With Cystic Fibrosis
- ClinicalTrials.gov ID
- NCT02239458
- Acronym / sponsor ID
- 0388-14-HMO
- Conditions
- Cystic Fibrosis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Ram WeissUniversity, hospital or other
- Study start
- Jun 2015
- Primary completion
- Jun 2016 (estimated)
- Study completion
- Jun 2016 (estimated)
- First posted
- 12 Sep 2014 (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.
Cystic fibrosis related diabetes (CFRD) is a common co-morbidity in patients with CF. The underlying pathophysiology of cystic fibrosis related diabetes (CFRD) is still a matter of investigation. In addition to localized tissue damage developing similar to that of the exocrine pancreas, other mechanisms may be involved. We have shown that a potential contributing factor to the patho-physiology of CFRD may be an abnormal gut derived hormonal profile, specifically of lower incretin hormone responses, prior to development of CFRD.
We propose that an altered incretin response, probably due to impaired interaction of nutrients with the gut mucosa due to thickened secretions, may play a role in the development of the disease. Specifically, low GIP and GLP-1, may explain the poor β-cell function observed in these patients prior to CFRD appearance. These incretins have known trophic effects on β-cells, and thus their lower levels may contribute to the development of quantitative as well as qualitative defects in β-cell function and thus may lead to the development of CFRD. Thus, increasing levels of these incretins using a DPP-IV inhibitor may improve glucose metabolism and delay/prevent the development of CFRD.
We hypothesize that Saxagliptin will increase the oDI compared to placebo and will thus provide relative protection from diabetes development and in addition we expect that Saxagliptin will lead to overall increased insulin concentrations and thus shift the metabolic milieu to a more anabolic state. This will manifest as weight gain and reduction in inflammation.
Detailed description
The following proposal includes testing the utility of DPP-IV inhibition in adult patients with CF without CFRD. This will be achieved by a randomized double blind controlled trial of Saxagliptin 5 mg vs. placebo which will be performed for 3 months in 60 patients with CF without CFRD. The study will be for 3 months of use and will consist of two arms:
- Saxagliptin 5mg
- Placebo. the primary outcome of this study will be the oral disposition index oDI , derived from the OGTT. The oDI has been shown across age groups and metabolic phenotypes to be an excellent predictor of diabetes development over time . We postulate that Saxagliptin will increase incretin concentrations and thus improve insulin secretion. This will manifest as an increased oral disposition index (oDI), reflecting an improved beta cell response in the context of prevailing insulin sensitivity. The oDI is a useful predictor of diabetes development over time and its increase will provide evidence for protection from diabetes in this special study population
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | –Placebo intake during 3 months |
| Saxagliptin 5mg | Active comparator | Drug: SaxagliptinSaxagliptin dose of 5mg for 3 months |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age greater than 18 years
- Diagnosis of CF
- No CFRD on baseline OGTT
- Normal kidney function
- No history of pancreatitis
Key exclusion criteria (2 listed)
- Acute illness/exacerbation of CF associated lung disease
- Receiving immune-modulators following lung/pancreas transplant
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 |
|---|---|---|
| SaxagliptinAlso: Onglyza | Drug | Saxagliptin 5mg |
Primary outcome
Oral Disposition Index
Time frame: The ODI will be calculated at baseline (Day 1) and at End point (day 90- 3 months)
The oDI is a useful predictor of diabetes development over time and its increase will provide evidence for protection from diabetes in this special study population
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2015.
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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.
Eitan Kerem, MD principal investigator
Hadassah Ein Kerem
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Saxagliptin in people with Cystic Fibrosis, run by Ram Weiss at 1 site in Israel.
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 6 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: status not confirmed, as of the sponsor's last update on 16 Apr 2015. 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 Israel. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ram Weiss, MD PhD (+972-50-894-6469, ramw@ekmd.huji.ac.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Oral Disposition Index (time frame: The ODI will be calculated at baseline (Day 1) and at End point (day 90- 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 16 Apr 2015.