Liraglutide Treatment in Patients With Maturity-onset Diabetes of the Young (MODY)
Part of paid clinical trials in Cincinnati, Ohio.
- Sponsor
- Mansa
- Study ID
- NCT07029009
- Phase
- PHASE2
- Status
- Recruiting
Conditions
- Maturity Onset Diabetes of the Young
Eligibility Criteria
- Sex
- ALL
- Age
- 10 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Liraglutide — DRUGLiraglutide will be prescribed following FDA approved packet insert for type 2 diabetes in our test population.
Study Details
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.
Key Dates
- Start date
- May 8, 2025
- Status verified
- Dec 2024
- Primary completion
- Aug 31, 2026
- Completion
- Jan 31, 2027
Study Design
- Enrollment
- 50 participants (estimated)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: liraglutide treatmentAfter 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.
Primary Outcome Measure
Blood sugar control - HbA1C [ Time Frame: Baseline and 3 months after study treatment initiation ]
Central Contacts
- Mansa Krishnamurthy, M.D.513-636-4744
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Cincinnati Children's Hospital Medical Center | Cincinnati | Ohio | 45229 | Mansa Krishnamurthy (PRINCIPAL_INVESTIGATOR) Lily Deng (SUB_INVESTIGATOR) |