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RECRUITINGPhase 2INTERVENTIONAL

Liraglutide Treatment in Patients With Maturity-onset Diabetes of the Young (MODY)

Investigating Enteroendocrine Dysfunction, Metabolism, and Response to Liraglutide in Patients With Maturity-onset Diabetes of the Young (MODY)

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

The reason for this research study is to better understand the use of liraglutide, a commonly prescribed Type 2 diabetes medication, in patients with a diagnosis of maturity-onset diabetes of the young (MODY). The investigators are interested in better understanding the way that this drug affects the metabolism and hormone levels of a person with MODY. Many people with MODY report having gastrointestinal (GI) issues such as an upset stomach. Investigators also are interested in finding out if this drug will help with GI issues. If liraglutide does help with this symptom of MODY, the investigators want to know why this happens. If this drug is effective for participants, the investigators will use participants cells to make human induced pluripotent stem cell (iPSC). This means that the investigators will use participant cells to create what are called stem cells, which are cells in the body that are able to be told what their job is. Investigators will use these cells to see what happens in gastrointestinal (GI) tract.

Who May Be Eligible (Plain English)

Who May Qualify: - Diagnosis of MODY via genetic testing - HgbA1c \>6.5% Who Should NOT Join This Trial: - History of anaphylaxis to GLP-1 receptor agonists - Already taking GLP-1 receptor agonists - on medications within the stimulant class - have had bariatric surgery - personal or family history of cancer, especially medullary thyroid cancer - personal history of pancreatitis or pathogenic variants associated with increased risk of pancreatitis - known active kidney disease - severe hypoglycemia (glucose \< 50 mg/dL) within 3 months of study enrollment - HbA1c \> 10.0% - episode of diabetic ketoacidosis (DKA) in the past 3 months - are currently pregnant - BMI \< 18.5 kg/m2 and pediatric patients with BMI \< 5th percentile Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: * Diagnosis of MODY via genetic testing * HgbA1c \>6.5% Exclusion Criteria: * History of anaphylaxis to GLP-1 receptor agonists * Already taking GLP-1 receptor agonists * on medications within the stimulant class * have had bariatric surgery * personal or family history of cancer, especially medullary thyroid cancer * personal history of pancreatitis or pathogenic variants associated with increased risk of pancreatitis * known active kidney disease * severe hypoglycemia (glucose \< 50 mg/dL) within 3 months of study enrollment * HbA1c \> 10.0% * episode of diabetic ketoacidosis (DKA) in the past 3 months * are currently pregnant * BMI \< 18.5 kg/m2 and pediatric patients with BMI \< 5th percentile

Treatments Being Tested

DRUG

Liraglutide

Liraglutide will be prescribed following FDA approved packet insert for type 2 diabetes in our test population.

Locations (1)

Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States