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| Name | Class |
|---|---|
| University of Copenhagen | OTHER |
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Maturity onset diabetes of the young (MODY) is a subtype of diabetes which is caused by mutations in specific genes leading to diabetes. The most common cause of MODY is due to mutations in the gene hepatocyte nuclear factor 1 alpha (HNF1A) and is consequently named HNF1A-MODY (or MODY3). HNF1A-MODY is associated with urinary excretion of glucose at lower blood glucose levels compared to other types of diabetes. Normally, glucose is reabsorbed by sodium-glucose cotransporter 2 (SGLT2), but SGLT2 is downregulated due to the mutation in HNF1A. Investigators aim to evaluate the impact of the decreased expression of SGLT2 on glucosuria in patients with HNF1A-MODY compared to patients with type 2 diabetes (T2D) using a single dose of an SGLT2 inhibitor during a glucose clamp experiment.
Participants: Patients with HNF1A-MODY (n=12) and patients with T2D (n=12)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HNF1A-MODY - SGLT2 inhibition | Active Comparator | 3-hour hyperglycemic clamp with inhibition of SGLT2 (single-dose empagliflozin 25 mg two hours before clamp) |
|
| HNF1A-MODY - Placebo | Placebo Comparator | 3-hour hyperglycemic clamp without inhibition of SGLT2 (placebo comparator to empagliflozin) |
|
| Type 2 Diabetes - SGLT2 inhibition | Active Comparator | 3-hour hyperglycemic clamp with inhibition of SGLT2 (single-dose empagliflozin 25 mg two hours before clamp) |
|
| Type 2 Diabetes - Placebo | Placebo Comparator | 3-hour hyperglycemic clamp without inhibition of SGLT2 (placebo comparator to empagliflozin) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hyperglycaemic clamp | Other | Three-hour, three-step glucose clamp with plasma glucose targets 10, 14 and 18 mmol/l (each one hour) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Urinary glucose excretion | Assesed during 3 hour hyperglycaemic clamp |
| Measure | Description | Time Frame |
|---|---|---|
| Urinary glucose excretion adjusted for glomerular filtration rate (GFR) | GFR: 99mTc-diethylenetriaminepentaacetic acid (99mTc-DTPA) plasma clearance | Assesed during 3 hour hyperglycaemic clamp |
| Infused amount of glucose |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tina Vilsbøll | Steno Diabetes Center Copenhagen | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Steno Diabetes Center Copenhagen | Herlev | 2730 | Denmark |
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| ID | Term |
|---|---|
| C563933 | Maturity-Onset Diabetes of the Young, Type 3 |
| D003924 | Diabetes Mellitus, Type 2 |
| D006029 | Glycosuria |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| C570240 | empagliflozin |
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| Placebo | Drug | Placebo comparator to empagliflozin |
|
| Empagliflozin | Drug | Single-dose, 25 mg, two hours before clamp |
|
| Assesed during 3 hour hyperglycaemic clamp |
| Urine volume | Assesed during 3 hour hyperglycaemic clamp |
| Glucose tissue disposal | difference between infused and excreted glucose | Assesed during 3 hour hyperglycaemic clamp |
| Urinary creatinine clearance | Urinary creatinine clearance calculated by plasma creatinine concentration and urinary creatinine excretion | Assesed during 3 hour hyperglycaemic clamp |
| Concentration of plasma c-peptide | Summarized as area under the curve (AUC) | Assesed during 3 hour hyperglycaemic clamp |
| Concentration of plasma glucagon | Summarized as AUC | Assesed during 3 hour hyperglycaemic clamp |
| Renal threshold of glucose excretion | Estimated using plasma glucose concentrations, urinary glucose excretion and GFR | Assesed during 3 hour hyperglycaemic clamp |
| D004700 | Endocrine System Diseases |
| D014555 | Urination Disorders |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |