Liraglutide Treatment in Patients With Maturity-onset Diabetes of the Young (MODY)
NCT ID: NCT07029009
Last Updated: 2025-12-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
50 participants
INTERVENTIONAL
2025-05-08
2027-01-31
Brief Summary
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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.
Detailed Description
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The hypothesis is that heterozygous mutations in MODY-related genes contribute to a range of GI pathologies, including regional disruptions in epithelial identity and disturbances in the function of EECs. Thus, patients with MODY may experience improvement not only in HbA1c and BMI but also in GI symptoms with initiation of GLP-1 receptor agonists. Investigators plan to enroll approximately 50 patients with MODY and obtain baseline metabolic labs and imaging along with enteroendocrine labs before initiating liraglutide and assessing response with repeat labs and imaging. This project will provide further guidance for clinical care and treatment of patients with MODY.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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liraglutide treatment
After baseline evaluation of enteroendocrine levels and metabolism, study participants will be prescribed liraglutide. Titration of liraglutide will be as follows: 1) Starting dose of liraglutide 0.6 mg daily for 1 week, 2) Increase to liraglutide 1.2 mg daily for 1 week, and 3) Maintain at final dose of liraglutide 1.8 mg daily. If study participants are unable to tolerate liragultide 1.8 mg daily due to side effects for 1 week, then will decrease back to liraglutide 1.2 mg daily.
Liraglutide
Liraglutide will be prescribed following FDA approved packet insert for type 2 diabetes in our test population.
Interventions
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Liraglutide
Liraglutide will be prescribed following FDA approved packet insert for type 2 diabetes in our test population.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* HgbA1c \>6.5%
Exclusion Criteria
* 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
10 Years
ALL
No
Sponsors
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Mansa
OTHER
Responsible Party
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Mansa
ASSISTANT PROFESSOR
Principal Investigators
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Mansa Krishnamurthy, M.D.
Role: PRINCIPAL_INVESTIGATOR
Children's Hospital Medical Center, Cincinnati
Locations
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Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2024-0426
Identifier Type: -
Identifier Source: org_study_id