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| Name | Class |
|---|---|
| Oxford University Hospitals NHS Trust | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Omission of gliclazide | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Omission of gliclazide | Other | Participants will stop taking gliclazide for 3 days. Data from the OGTT will be compared with that prior to stopping the medication. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 0min, 30min, 60min, 90min and 120min during 75g oral glucose tolerance test. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 0min, 30min, 60min, 90min and 120min during 75g oral glucose tolerance test. |
| Change in plasma non-esterified fatty acids (NEFA) from baseline (0min) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ioannis Spiliotis, MD | University of Oxford | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Research Unit, OCDEM, Churchill Hospital | Oxford | Oxfordshire | OX3 7LE | United Kingdom |
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.
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Jul 3, 2023 | |
| Reset | Feb 15, 2024 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jul 3, 2023 | Feb 15, 2024 |
| ID | Term |
|---|---|
| C565101 | Maturity-Onset Diabetes of the Young, Type 1 |
| C563933 | Maturity-Onset Diabetes of the Young, Type 3 |
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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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. |
| 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). | 12 days |