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 — DRUG
    Liraglutide 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 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.

Primary Outcome Measure

Blood sugar control - HbA1C [ Time Frame: Baseline and 3 months after study treatment initiation ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Cincinnati Children's Hospital Medical CenterCincinnatiOhio45229
Lily Deng
513-636-0002
Mansa Krishnamurthy (PRINCIPAL_INVESTIGATOR)
Lily Deng (SUB_INVESTIGATOR)

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