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

ConditionMaturity Onset Diabetes of the Young
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age10+
SponsorMansa

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Diagnosis of MODY via genetic testing

HgbA1c >6.5%

Disqualifiers

History of anaphylaxis to GLP-1 receptor agonists

Already taking GLP-1 receptor agonists

on medications within the stimulant class

have had bariatric surgery

Trial design

Design model

Single group

Treatments tested in this trial

  • Liraglutide

    Drug

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

Treatment groups

50 Participants
are divided into 1 treatment group
Group A: liraglutide treatmentExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Blood sugar control - HbA1C

Hemoglobin A1c

Time frame
Baseline and 3 months after study treatment initiation
2

BMI

Body mass index; weight and height will be combined to report BMI in kg/m\^2

Time frame
baseline, 1 month, 2 months, and final study visit 3 months after study treatment initiation

Secondary outcomes

1

Metabolic - Blood Sugar

Glycemic patterns observed utilizing a continuous glucose monitor

Time frame
Baseline through three months of study treatment
2

Enteroendocrine function - GI symptoms

ANMS Gastroparesis Cardinal Symptom Index Daily Diary (ANMS GCSI-DD)

Time frame
baseline, 1 month, 2 months, and final study visit 3 months after study treatment initiation
3

Enteroendocrine function - insulin

Fasting and post meal blood serum insulin levels will be assessed

Time frame
baseline and 3 months after study treatment initiation
4

Enteroendocrine function - c-peptide

Fasting and post meal blood serum c-peptide levels will be assessed

Time frame
baseline and 3 months after study treatment initiation

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Mansa

Lead sponsor

Children's Hospital Medical Center, Cincinnati

Sponsor institution

Source ClinicalTrials.gov
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