CompletedNot Applicable

Impact of SGLT2 on Glucosuria in HNF1A-MODY

Denmark21 participantsStarted 2022-06-22

Plain-language summary

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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Age ≥18 years * HNF1A-MODY verified by genetic testing (only patients with HNF1A-MODY) * Type 2 diabetes diagnosis according to World Health Organization (only patients with type 2 diabetes) * Treatment with diet and/or a glucose-lowering drug (only patients with HNF1A-MODY) * Normal haemoglobin (males 8.3-10.5 mmol/l, females 7.3-9.5 mmol/l) * Informed consent Exclusion Criteria: * Nephropathy (estimated GFR \<60 ml/min/1.73m2 and/or albuminuria) * Known significant liver disease and/or plasma alanine aminotransferase (ALT) and/or plasma aspartate aminotransferase (AST) above 2 × normal values) * Pregnancy or breastfeeding * Treatment with SGLT2 inhibitor * Fasting plasma glucose \> 10 mmol/l * Family history of HNF1A-MODY (only patients with type 2 diabetes)

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Urinary glucose excretion

Timeframe: Assesed during 3 hour hyperglycaemic clamp

Trial details

NCT IDNCT05417646

SponsorSteno Diabetes Center Copenhagen

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-06-14

View on ClinicalTrials.gov More Maturity-Onset Diabetes of the Young, Type 3 trials