MODY1NCT03246828
Glucagon in MODY (Maturity Onset Diabetes of the Young)
A study testing Omission of gliclazide in people with MODY1 and MODY3, run by University of Oxford at 1 site in United Kingdom.
Trial summary
The aim of this study is to determine whether fasting and post-prandial glucagon secretion is suppressed by gliclazide in patients with HNF1-/4-alpha MODY. Participants will undergo an oral glucose tolerance test (OGTT) before and after omitting their gliclazide medication for 3 days. Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- Omission of gliclazide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 3 Jul 2017to 1 Aug 2022
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of HNF1-alpha or HNF4-alpha MODY.
- Currently on gliclazide treatment
Who cannot join
- Currently taking any anti-diabetic medication other than gliclazide and metformin
- Oral steroid treatment 30 days prior to the start or at any time during the study period.
- Known malignancy or any other condition or circumstance which, in the opinion of the investigator, would affect the patient's ability to participate in the protocol.
- Felt to be unsuitable to participate in the study in the opinion of the Chief Investigator.
- Currently participating in a clinical trial involving an anti-diabetic medication
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Clinical Research Unit, OCDEM, Churchill Hospital
Oxford, Oxfordshire, OX3 7LE
About this study
Official title: Investigating Glucagon Secretion in HNF1-alpha and HNF4-alpha MODY
The aim of this study is to determine whether fasting and post-prandial glucagon secretion is suppressed by gliclazide in patients with HNF1-/4-alpha MODY. Participants will undergo an oral glucose tolerance test (OGTT) before and after omitting their gliclazide medication for 3 days.
- Being tested
- Omission of gliclazide
- Keywords
- gliclazide, glucagon, diabetes
- Medical subject headings
- Maturity-Onset Diabetes of the Young, Type 1, Maturity-Onset Diabetes of the Young, Type 3, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Omission of gliclazideOther
Participants will stop taking gliclazide for 3 days. Data from the OGTT will be compared with that prior to stopping the medication.
| Study group | Role | What they receive |
|---|---|---|
| Omission of gliclazide | Experimental | Not described Receives: Other: Omission of gliclazide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in plasma glucagon from baseline (0min)
Change in the concentration of plasma glucagon from baseline during an oral glucose tolerance test (OGTT), while on gliclazide and after a washout period.
Measured: 0min, 30min, 60min, 90min and 120min during 75g oral glucose tolerance test.
Secondary outcomes (3)
Change in plasma c-peptide from baseline (0min)
To determine whether changes in post-prandial glucagon levels correlate with changes in c-peptide levels in HNF1-/4-alpha MODY patients on and off gliclazide.
Measured: 0min, 30min, 60min, 90min and 120min during 75g oral glucose tolerance test.
Change in plasma non-esterified fatty acids (NEFA) from baseline (0min)
To determine whether changes in post-prandial glucagon levels correlate with changes in NEFA levels in HNF1-/4-alpha MODY patients on and off gliclazide.
Measured: 0min, 30min, 60min, 90min and 120min during 75g oral glucose tolerance test.
Continuous glucose monitor recordings
To assess the blood glucose variability on and off gliclazide treatment (only for participants who opt to take part in this optional component).
Measured: 12 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2017
- Study start3 Jul 2017
- Primary completion29 Jul 2022
- Study completion1 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MODY1Studies of the same condition, open and under way.
- More trials run by University of OxfordThe 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
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oxford
- Sponsor type
- University, hospital or other
- Collaborators
- Oxford University Hospitals NHS Trust
- Responsible party
- Sponsor
- Investigators
- Ioannis Spiliotis, MD, Principal investigator, University of Oxford
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03246828
- Sponsor's protocol ID
- 12538
- Status last verified
- Aug 2022
- First submitted
- 4 Jul 2017
- Last updated
- 17 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The anonymised data (i.e. with studyID only) generated from this study will be deposited in the Oxford Research Archive (http://ora.ox.ac.uk/). This will provide a link between the results presented in publications and the underlying data. At the end of the retention period (currently 5 years), the data will be deleted from the archive. The anonymised data may still be used in future research.
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating Glucagon Secretion in HNF1-alpha and HNF4-alpha MODY
- ClinicalTrials.gov ID
- NCT03246828
- Acronym / sponsor ID
- 12538
- Keywords
- gliclazide, glucagon, diabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University of OxfordUniversity, hospital or other
- Collaborators
- Oxford University Hospitals NHS Trust
- Study start
- 3 Jul 2017 (actual)
- Primary completion
- 29 Jul 2022 (actual)
- Study completion
- 1 Aug 2022 (actual)
- First posted
- 11 Aug 2017 (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.
The aim of this study is to determine whether fasting and post-prandial glucagon secretion is suppressed by gliclazide in patients with HNF1-/4-alpha MODY. Participants will undergo an oral glucose tolerance test (OGTT) before and after omitting their gliclazide medication for 3 days.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Omission of gliclazide | Experimental | Other: Omission of gliclazide |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Diagnosis of HNF1-alpha or HNF4-alpha MODY.
- Currently on gliclazide treatment
Key exclusion criteria (5 listed)
- Currently taking any anti-diabetic medication other than gliclazide and metformin
- Oral steroid treatment 30 days prior to the start or at any time during the study period.
- Known malignancy or any other condition or circumstance which, in the opinion of the investigator, would affect the patient's ability to participate in the protocol.
- Felt to be unsuitable to participate in the study in the opinion of the Chief Investigator.
- Currently participating in a clinical trial involving an anti-diabetic medication
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 |
|---|---|---|
| Omission of gliclazideParticipants will stop taking gliclazide for 3 days. Data from the OGTT will be compared with that prior to stopping the medication. | Other | Omission of gliclazide |
Primary outcome
Change in plasma glucagon from baseline (0min)
Time frame: 0min, 30min, 60min, 90min and 120min during 75g oral glucose tolerance test.
Change in the concentration of plasma glucagon from baseline during an oral glucose tolerance test (OGTT), while on gliclazide and after a washout period.
3 secondary outcomes
Change in plasma c-peptide from baseline (0min)
Time frame: 0min, 30min, 60min, 90min and 120min during 75g oral glucose tolerance test.
Change in plasma non-esterified fatty acids (NEFA) from baseline (0min)
Time frame: 0min, 30min, 60min, 90min and 120min during 75g oral glucose tolerance test.
Continuous glucose monitor recordings
Time frame: 12 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 17 Aug 2022.
- Individual participant dataSharing planned: Yes. The anonymised data (i.e. with studyID only) generated from this study will be deposited in the Oxford Research Archive (http://ora.ox.ac.uk/). This will provide a link between the results presented in publications and the underlying data. At the end of the retention period (currently 5 years), the data will be deleted from the archive. The anonymised data may still be used in future research.
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.
Ioannis Spiliotis, MD principal investigator
University of Oxford
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Omission of gliclazide in people with MODY1 and MODY3, run by University of Oxford 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?
The sponsor lists 2 inclusion and 5 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 17 Aug 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 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 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?
Change in plasma glucagon from baseline (0min) (time frame: 0min, 30min, 60min, 90min and 120min during 75g oral glucose tolerance test.). 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 17 Aug 2022.