Impact of SGLT2 on Glucosuria in HNF1A-MODY

Sponsor
Steno Diabetes Center Copenhagen
Study ID
NCT05417646
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Hyperglycaemic clamp — OTHER
    Three-hour, three-step glucose clamp with plasma glucose targets 10, 14 and 18 mmol/l (each one hour)
  • Placebo — DRUG
    Placebo comparator to empagliflozin
  • Empagliflozin — DRUG
    Single-dose, 25 mg, two hours before clamp

Study Details

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.

Key Dates

Start date
Jun 22, 2022
Status verified
Jul 2023
Primary completion
Jun 14, 2023
Completion
Jun 14, 2023

Study Design

Enrollment
21 participants (actual)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE

Arms

  • Active Comparator: HNF1A-MODY - SGLT2 inhibition
    3-hour hyperglycemic clamp with inhibition of SGLT2 (single-dose empagliflozin 25 mg two hours before clamp)
  • Placebo Comparator: HNF1A-MODY - Placebo
    3-hour hyperglycemic clamp without inhibition of SGLT2 (placebo comparator to empagliflozin)
  • Active Comparator: Type 2 Diabetes - SGLT2 inhibition
    3-hour hyperglycemic clamp with inhibition of SGLT2 (single-dose empagliflozin 25 mg two hours before clamp)
  • Placebo Comparator: Type 2 Diabetes - Placebo
    3-hour hyperglycemic clamp without inhibition of SGLT2 (placebo comparator to empagliflozin)

Primary Outcome Measure

Urinary glucose excretion [ Time Frame: Assesed during 3 hour hyperglycaemic clamp ]

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