Cystic FibrosisEarly Phase 1NCT02398383
Role of Glucagon In Glucose Control in Cystic Fibrosis Related Diabetes
A Early Phase 1 study testing Oral Glucose Tolerance Test, Mixed Meal Tolerance Test and Hypoglycemic Clamp in people with Cystic Fibrosis and Cystic Fibrosis Related Diabetes, run by Yale University at 1 site in United States.
Trial summary
This project is designed to begin to characterize the abnormalities of glucagon secretion in subjects with cystic fibrosis related diabetes along the spectrum of glucose tolerance. Read more about this study
- Who is it for?
- Ages 12 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Cystic Fibrosis, Cystic Fibrosis Related Diabetes
- What is being tested?
- Oral Glucose Tolerance Test, Mixed Meal Tolerance Test and Hypoglycemic Clamp
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2015to 22 Jun 2017
- Phase
- Early Phase 1
- 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 12 to 45 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Diagnosis of CF by clinical or genetic determination
- Normal glucose tolerance or CFRD
- Subjects routinely taking systemic or inhaled glucocorticoids on stable regimen are eligible
Who cannot join
- Subjects with active pulmonary infection requiring supplemental doses of corticosteroids
- Use of any oral diabetes medications
- Subjects who are pregnant/lactating
- Subjects with poor compliance with pancreatic enzyme replacement therapy
- Control Subjects:
- Approximately 10 control subjects who are matched for age, gender, are expected to be enrolled in the study. Non-CF subjects must be >12 years old, in good health and not taking any medications or have any medical problems the doctor feels would prevent the subject from completing the study and have BMI between 15-85% for age and gender. Control subjects whose fasting blood glucose is found to be >110 mg/dL will not be continued in the study.
Trial locations and contacts
1 site in 1 country.
United States1 site
Yale New Haven Hospital
New Haven, Connecticut, 06511
About this study
Official title: Role of Glucagon in Glucose Control in Cystic Fibrosis Related Diabetes
This project is designed to begin to characterize the abnormalities of glucagon secretion in subjects with cystic fibrosis related diabetes along the spectrum of glucose tolerance. Cystic fibrosis patients with normal glucose tolerance as well as cystic fibrosis related diabetes as well as control subjects will undergo an oral glucose tolerance test, mixed meal tolerance test, and one step hypoglycemic clamp. Cystic fibrosis patients will then return 12 months later to undergo repeat mixed meal tolerance test and hypoglycemic clamp test.
Read the detailed description
This project is designed to begin to characterize the abnormalities of glucagon secretion in subjects with cystic fibrosis related diabetes along the spectrum of glucose tolerance. This will be a descriptive, cross-sectional and longitudinal cohort study in a sample of children and young adults with CF and a continuum of glucose tolerance compared to healthy age-matched controls.
Cystic fibrosis patients with normal glucose tolerance as well as cystic fibrosis related diabetes as well as control subjects will be admitted to the research unit on three separate occasions to undergo an oral glucose tolerance test, mixed meal tolerance test, and one step hypoglycemic clamp. Cystic fibrosis patients will then return 12 months later to undergo repeat mixed meal tolerance test and hypoglycemic clamp test.
- Conditions
- Cystic Fibrosis, Cystic Fibrosis Related Diabetes
- Being tested
- Oral Glucose Tolerance Test, Mixed Meal Tolerance Test, Hypoglycemic Clamp
- 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 TestOther
Subjects will be instructed to fast after midnight the night prior to the study. Subjects will be admitted to the research unit on the morning of the test for placement of blood-drawing IV for frequent sampling. Patients will drink 1.75 gm/kg glucose (Glucola) to a maximum of 75 gm. Venous samples for glucose and c-peptide will be drawn from the IV at 0, 30, 60, 90 and 120 minutes. Subjects will be instructed to eat at least 75 gm carbohydrates daily in the week prior to this test.
Mixed Meal Tolerance TestOther
Subjects will be instructed to fast after midnight the night prior to the study. Subjects will be admitted to the research unit on the morning of the test for placement of blood-drawing IV for frequent sampling. Subjects will consume 6 kcal/kg (6 ml/kg) Boost High Protein Nutritional Energy Drink (Mead-Johnson) over five minutes to a maximum of 360 ml. Venous samples for glucose, glucagon, GLP-1, GIP, and c-peptide will be drawn at -10, 0, 15, 30, 60, 90, 120, 150, 180, 210, and 240 minutes.
Hypoglycemic ClampOther
All subjects with CF and adult (but not pediatric) controls will undergo one-step hypoglycemic clamp. Subjects will be instructed to fast after midnight the night prior to the study. Subjects will be admitted to the research unit on the morning of the test for placement of blood-drawing IV for frequent sampling and a second IV for infusion of insulin and dextrose.
| Study group | Role | What they receive |
|---|---|---|
| CF with Normal Glucose Tolerance | Experimental | Individuals with CF without cystic fibrosis related diabetes Receives: Other: Oral Glucose Tolerance Test; Other: Mixed Meal Tolerance Test; Other: Hypoglycemic Clamp |
| Cystic Fibrosis Related Diabetes | Experimental | Individuals with cystic fibrosis and cystic fibrosis related diabetes Receives: Other: Oral Glucose Tolerance Test; Other: Mixed Meal Tolerance Test; Other: Hypoglycemic Clamp |
| Control | Active comparator | Age matched control subjects Receives: Other: Oral Glucose Tolerance Test; Other: Mixed Meal Tolerance Test; Other: Hypoglycemic Clamp |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glucagon levels
Glucagon levels in response to to a mixed meal stimulus
Measured: baseline
Secondary outcomes (11)
C-peptide levels
C-peptide levels during oral glucose tolerance test and mixed meal tolerance test
Measured: baseline
C-peptide levels
C-peptide levels during oral glucose tolerance test and mixed meal tolerance test
Measured: 12 months
Epinephrine levels
Epinephrine and norepinephrine levels during hypoglycemic clamp
Measured: baseline
Epinephrine levels
Epinephrine and norepinephrine levels during hypoglycemic clamp
Measured: 12 months
Norepinephrine levels
norepinephrine levels during hypoglycemic clamp
Measured: baseline
Norepinephrine levels
norepinephrine levels during hypoglycemic clamp
Measured: 12 months
Hypoglycemia unawareness scores
Hypoglycemia unawareness scores in subjects during hypoglycemic clamps as measured by the Clarke Hypoglycemia Awareness survey
Measured: Baseline
Hypoglycemia unawareness scores
Hypoglycemia unawareness scores in subjects during hypoglycemic clamps as measured by the Clarke Hypoglycemia Awareness survey
Measured: 12 months
GLP-1 and GIP levels
GLP-1 and GIP levels in response to mixed meal stimulus
Measured: Baseline
GLP-1 and GIP levels
GLP-1 and GIP levels in response to mixed meal stimulus
Measured: 12 months
Glucagon levels
Glucagon levels in response to to a mixed meal stimulus and difference from baseline
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2015 (estimated)
- Study startMar 2015
- Primary completion22 Jun 2017
- Study completion22 Jun 2017
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.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- 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
- Early Phase 1
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Bracha Goldsweig, MD, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02398383
- Sponsor's protocol ID
- 1409014580
- Status last verified
- Jun 2020
- First submitted
- 22 Jan 2015
- Last updated
- 26 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Glucagon in Glucose Control in Cystic Fibrosis Related Diabetes
- ClinicalTrials.gov ID
- NCT02398383
- Acronym / sponsor ID
- 1409014580
- Conditions
- Cystic Fibrosis, Cystic Fibrosis Related Diabetes
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Study start
- Mar 2015
- Primary completion
- 22 Jun 2017 (actual)
- Study completion
- 22 Jun 2017 (actual)
- First posted
- 25 Mar 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.
This project is designed to begin to characterize the abnormalities of glucagon secretion in subjects with cystic fibrosis related diabetes along the spectrum of glucose tolerance. Cystic fibrosis patients with normal glucose tolerance as well as cystic fibrosis related diabetes as well as control subjects will undergo an oral glucose tolerance test, mixed meal tolerance test, and one step hypoglycemic clamp. Cystic fibrosis patients will then return 12 months later to undergo repeat mixed meal tolerance test and hypoglycemic clamp test.
Detailed description
This project is designed to begin to characterize the abnormalities of glucagon secretion in subjects with cystic fibrosis related diabetes along the spectrum of glucose tolerance. This will be a descriptive, cross-sectional and longitudinal cohort study in a sample of children and young adults with CF and a continuum of glucose tolerance compared to healthy age-matched controls.
Cystic fibrosis patients with normal glucose tolerance as well as cystic fibrosis related diabetes as well as control subjects will be admitted to the research unit on three separate occasions to undergo an oral glucose tolerance test, mixed meal tolerance test, and one step hypoglycemic clamp. Cystic fibrosis patients will then return 12 months later to undergo repeat mixed meal tolerance test and hypoglycemic clamp test.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| CF with Normal Glucose Tolerance | Experimental | Other: Oral Glucose Tolerance Test, Other: Mixed Meal Tolerance Test, Other: Hypoglycemic ClampIndividuals with CF without cystic fibrosis related diabetes |
| Cystic Fibrosis Related Diabetes | Experimental | Other: Oral Glucose Tolerance Test, Other: Mixed Meal Tolerance Test, Other: Hypoglycemic ClampIndividuals with cystic fibrosis and cystic fibrosis related diabetes |
| Control | Active comparator | Other: Oral Glucose Tolerance Test, Other: Mixed Meal Tolerance Test, Other: Hypoglycemic ClampAge matched control subjects |
Who may qualify
- Ages
- 12 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Diagnosis of CF by clinical or genetic determination
- Normal glucose tolerance or CFRD
- Subjects routinely taking systemic or inhaled glucocorticoids on stable regimen are eligible
Key exclusion criteria (6 listed)
- Subjects with active pulmonary infection requiring supplemental doses of corticosteroids
- Use of any oral diabetes medications
- Subjects who are pregnant/lactating
- Subjects with poor compliance with pancreatic enzyme replacement therapy
- Approximately 10 control subjects who are matched for age, gender, are expected to be enrolled in the study. Non-CF subjects must be >12 years old, in good health and not taking any medications or have any medical problems the doctor feels would prevent the subject from completing the study and have BMI between 15-85% for age and gender. Control subjects whose fasting blood glucose is found to be >110 mg/dL will not be continued in the study.
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 TestSubjects will be instructed to fast after midnight the night prior to the study. Subjects will be admitted to the research unit on the morning of the test for placement of blood-drawing IV for frequent sampling. Patients will drink 1.75 gm/kg glucose (Glucola) to a maximum of 75 gm. Venous samples for glucose and c-peptide will be drawn from the IV at 0, 30, 60, 90 and 120 minutes. Subjects will be instructed to eat at least 75 gm carbohydrates daily in the week prior to this test. | Other | CF with Normal Glucose Tolerance, Control, Cystic Fibrosis Related Diabetes |
| Mixed Meal Tolerance TestSubjects will be instructed to fast after midnight the night prior to the study. Subjects will be admitted to the research unit on the morning of the test for placement of blood-drawing IV for frequent sampling. Subjects will consume 6 kcal/kg (6 ml/kg) Boost High Protein Nutritional Energy Drink (Mead-Johnson) over five minutes to a maximum of 360 ml. Venous samples for glucose, glucagon, GLP-1, GIP, and c-peptide will be drawn at -10, 0, 15, 30, 60, 90, 120, 150, 180, 210, and 240 minutes. | Other | CF with Normal Glucose Tolerance, Control, Cystic Fibrosis Related Diabetes |
| Hypoglycemic ClampAll subjects with CF and adult (but not pediatric) controls will undergo one-step hypoglycemic clamp. Subjects will be instructed to fast after midnight the night prior to the study. Subjects will be admitted to the research unit on the morning of the test for placement of blood-drawing IV for frequent sampling and a second IV for infusion of insulin and dextrose. | Other | CF with Normal Glucose Tolerance, Control, Cystic Fibrosis Related Diabetes |
Primary outcome
Glucagon levels
Time frame: baseline
Glucagon levels in response to to a mixed meal stimulus
11 secondary outcomes
C-peptide levels
Time frame: baseline
C-peptide levels
Time frame: 12 months
Epinephrine levels
Time frame: baseline
Epinephrine levels
Time frame: 12 months
Norepinephrine levels
Time frame: baseline
Norepinephrine levels
Time frame: 12 months
Hypoglycemia unawareness scores
Time frame: Baseline
Hypoglycemia unawareness scores
Time frame: 12 months
GLP-1 and GIP levels
Time frame: Baseline
GLP-1 and GIP levels
Time frame: 12 months
Glucagon levels
Time frame: 12 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 26 Jun 2020.
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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.
Bracha Goldsweig, MD principal investigator
Yale University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Oral Glucose Tolerance Test, Mixed Meal Tolerance Test and Hypoglycemic Clamp in people with Cystic Fibrosis and Cystic Fibrosis Related Diabetes, run by Yale University 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 3 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 26 Jun 2020. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Glucagon levels (time frame: baseline). 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 26 Jun 2020.