Cystic FibrosisCF-DIABETESNCT03644199
Development of Diabetes in Adults With Cystic Fibrosis (CF)
A study testing Oral Glucose Tolerance Test (OGTT) assessment arm and Mixed meal test evaluation test arm in people with Cystic Fibrosis, run by Liverpool Heart and Chest Hospital NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
This is a crossover study to determine the possible factors that might be related to the development of diabetes in CF and examines the relationship between pancreatic fatigue if any, and the development of diabetes. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Cystic Fibrosis
- What is being tested?
- Oral Glucose Tolerance Test (OGTT) assessment arm and Mixed meal test evaluation test arm
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 30 Mar 2011to 30 Aug 2017
- 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
In order to participate in the study, the CF group must meet all the following inclusion criteria
- Male or female with a confirmed diagnosis of cystic fibrosis defined by
- Clinical features consistent with a diagnosis of CF AND
- Sweat chloride ≥60mmol/L by pilocarpine ionotophoresis; OR
- Genotypic confirmation of CFTR mutation
- Aged 18 - 50 years
- Out-patients from the regional adult unit in Liverpool
- Currently not known to be diabetic or on insulin
- Clinically stable over the preceding 4 weeks i.e. no indication for iv antibiotics, steroids or hospital admissions
- Hemoglobin value >10g/dl
The inclusion criteria for the normal population group is as follows:
- Male or female with NO confirmed diagnosis of cystic fibrosis
- Aged 18 - 50 years
- Currently not known to be diabetic or on insulin
- Clinically stable over the preceding 4 weeks i.e. no indication for iv antibiotics, steroids or hospital admissions
- Hemoglobin value >10g/dl
In order to participate subjects must not meet any of the following exclusion criteria
- Patients with known diabetes or on glucose lowering medications (insulin, oral agents)
- On-going acute illness
- Those on long-term oral steroids
- Pregnant women
- Those on immunosuppressive treatment
- History of, or planned organ transplant
- Clinically significant abnormal findings on haematology or clinical chemistry
- Subjects with documented or suspected, clinically significant, alcohol or drug abuse. The determination of clinical significance will be determined by the investigator.
- Current malignant disease
- Any serious or active medical or psychiatric illness, which in eth opinion of the investigator, would interfere with subject treatment, assessment, or compliance with the protocol.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Liverpool Heart and Chest Hospital
Liverpool, L14 3PE
About this study
Official title: Factors Responsible for the Development of Diabetes in Adults With Cystic Fibrosis
This is a crossover study to determine the possible factors that might be related to the development of diabetes in CF and examines the relationship between pancreatic fatigue if any, and the development of diabetes. In addition hormones affecting the release of insulin and stomach motility will be studied to determine if there is a variation in response to solid and liquid meals and if this variation increases as fatigue progresses.
Read the detailed description
The main purpose of this study is to look at possible additional factors that might be related to the development of Cystic Fibrosis Related Diabetes (CFRD), that in itself is a unique entity and to identify an appropriate test to diagnose CFRD. There is well demonstrated evidence of delayed insulin release and peak in individuals with CF, the cause of which is not fully explained.
With a view to determine the cause of this phenomenon the aims of this study are:
- To determine whether pancreatic fatigue contributes to this delayed insulin release and peak that is seen in patients with cystic fibrosis.
- Should a glucose tolerance test be done at a later time in the day, as against first thing in the morning as is the current accepted standard?
- To determine if gastric emptying has a role to play in the development of CFRD?
- To study the hormone release response to a glucose challenge and the patterns of change through the day.
- To study the relationship of these hormones to gastric emptying and the development of diabetes.
- Conditions
- Cystic Fibrosis
- Being tested
- Oral Glucose Tolerance Test (OGTT) assessment arm, Mixed meal test evaluation test arm
- Keywords
- Gastric emptying, Cystic Fibrosis related diabetes, Incretins
- Medical subject headings
- Cystic Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral Glucose Tolerance Test (OGTT) assessment armOther
Hormonal and motility responses to a standard OGTT evaluation arm
Mixed meal test evaluation test armOther
Evaluate the hormonal and motility responses to a standard mixed meal test through the day
| Study group | Role | What they receive |
|---|---|---|
| OGTT test | Other | Comparison of responses to a OGTT between CF subjects and health control subjects Receives: Other: Oral Glucose Tolerance Test (OGTT) assessment arm |
| Mixed meal | Other | Comparison of responses to a mixed meal through the day between CF subjects and health control subjects Receives: Other: Mixed meal test evaluation test arm |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glucose levels
Glucose sensitivity test
Measured: 4 hours
Secondary outcomes (3)
Insulin responses
Insulin resistance test
Measured: 4 hours
GLP1 and GIP responses
GLP1 and GIP tests
Measured: 4 hours
Evaluation of gastric emptying
Gastric flow measurement
Measured: 8 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2018
- Study start30 Mar 2011 (estimated)
- Primary completion30 Jul 2013 (estimated)
- Study completion30 Aug 2017
Why it stopped: Lack of resources
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
- Other
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Liverpool Heart and Chest Hospital NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dilip Nazareth, MD, Principal investigator, Liverpool Heart & Chest Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03644199
- Sponsor's protocol ID
- 11-NW-0552
- Acronym
- CF-DIABETES
- Status last verified
- Aug 2018
- First submitted
- 10 May 2016
- Last updated
- 23 Aug 2018
- Results posted
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Factors Responsible for the Development of Diabetes in Adults With Cystic Fibrosis
- ClinicalTrials.gov ID
- NCT03644199
- Acronym / sponsor ID
- CF-DIABETES / 11-NW-0552
- Conditions
- Cystic Fibrosis
- Keywords
- Gastric emptying, Cystic Fibrosis related diabetes, Incretins
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Lack of resources
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Liverpool Heart and Chest Hospital NHS Foundation TrustUniversity, hospital or other
- Study start
- 30 Mar 2011 (estimated)
- Primary completion
- 30 Jul 2013 (estimated)
- Study completion
- 30 Aug 2017 (actual)
- First posted
- 23 Aug 2018 (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.
This is a crossover study to determine the possible factors that might be related to the development of diabetes in CF and examines the relationship between pancreatic fatigue if any, and the development of diabetes. In addition hormones affecting the release of insulin and stomach motility will be studied to determine if there is a variation in response to solid and liquid meals and if this variation increases as fatigue progresses.
Detailed description
The main purpose of this study is to look at possible additional factors that might be related to the development of Cystic Fibrosis Related Diabetes (CFRD), that in itself is a unique entity and to identify an appropriate test to diagnose CFRD. There is well demonstrated evidence of delayed insulin release and peak in individuals with CF, the cause of which is not fully explained.
With a view to determine the cause of this phenomenon the aims of this study are:
- To determine whether pancreatic fatigue contributes to this delayed insulin release and peak that is seen in patients with cystic fibrosis.
- Should a glucose tolerance test be done at a later time in the day, as against first thing in the morning as is the current accepted standard?
- To determine if gastric emptying has a role to play in the development of CFRD?
- To study the hormone release response to a glucose challenge and the patterns of change through the day.
- To study the relationship of these hormones to gastric emptying and the development of diabetes.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| OGTT test | Other | Other: Oral Glucose Tolerance Test (OGTT) assessment armComparison of responses to a OGTT between CF subjects and health control subjects |
| Mixed meal | Other | Other: Mixed meal test evaluation test armComparison of responses to a mixed meal through the day between CF subjects and health control subjects |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
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 |
|---|---|---|
| Oral Glucose Tolerance Test (OGTT) assessment armHormonal and motility responses to a standard OGTT evaluation arm | Other | OGTT test |
| Mixed meal test evaluation test armEvaluate the hormonal and motility responses to a standard mixed meal test through the day | Other | Mixed meal |
Primary outcome
Glucose levels
Time frame: 4 hours
Glucose sensitivity test
3 secondary outcomes
Insulin responses
Time frame: 4 hours
GLP1 and GIP responses
Time frame: 4 hours
Evaluation of gastric emptying
Time frame: 8 hours
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2018.
- Individual participant dataSharing planned: Undecided
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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.
Dilip Nazareth, MD principal investigator
Liverpool Heart & Chest Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oral Glucose Tolerance Test (OGTT) assessment arm and Mixed meal test evaluation test arm in people with Cystic Fibrosis, run by Liverpool Heart and Chest Hospital NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: withdrawn, as of the sponsor's last update on 23 Aug 2018. 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 Kingdom. 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 was withdrawn before enrolling participants, so there are no results.
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?
Glucose levels (time frame: 4 hours). 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 23 Aug 2018.