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Liraglutide Response Investigation in Maturity-onset Diabetes of the Young Patients with Enteroendocrine Dysfunction and Metabolism Issues

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Study AimThis study investigates how the drug Liraglutide affects blood sugar control and weight in adults with maturity-onset diabetes who have issues with enteroendocrine function. We will measure your Hemoglobin A1c and calculate your Body Mass Index to evaluate the effects of the treatment.
What is being tested

Liraglutide

Drug
Who is being recruted

Maturity Onset Diabetes of the Young

Over 10 Years
+14 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Treatment Study

Phase 2
Interventional
Study Start: May 2025

See protocol details

Summary

Principal SponsorMansa
Study ContactMansa Krishnamurthy, M.D.
Last updated: June 19, 2025
Sourced from a government-validated database.Claim as a partner
Study start date: May 8, 2025Actual date on which the first participant was enrolled.

This study focuses on individuals with a specific type of diabetes called Maturity-onset Diabetes of the Young (MODY). The goal is to understand how these patients' bodies process hormones and nutrients before and after they start taking a medication called liraglutide. Researchers hope that liraglutide will not only help improve blood sugar levels and weight but also alleviate digestive symptoms that some MODY patients experience. This research could lead to better treatment plans and care for people with this type of diabetes. Participants in the study will first undergo tests to measure their hormone levels and metabolism. After starting the liraglutide treatment, which is usually given as an injection, these tests will be repeated to see how their bodies respond. The study will track changes in blood sugar control, weight, and gastrointestinal symptoms. If certain individuals show significant improvement, scientists will use their cells to study why their bodies respond well to the medication. This approach seeks to uncover the underlying reasons for digestive issues in MODY patients and improve future treatments.

Official TitleInvestigating Enteroendocrine Dysfunction, Metabolism, and Response to Liraglutide in Patients With Maturity-onset Diabetes of the Young (MODY) 
Principal SponsorMansa
Study ContactMansa Krishnamurthy, M.D.
Last updated: June 19, 2025
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details
50 patients to be enrolledTotal number of participants that the clinical trial aims to recruit.
Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

How participants are assigned to different groups/arms
In this clinical study, all participants receive the same treatment. Since there is only one group, there is no need for randomization or assignment to different arms. This type of study is often used to test a new treatment without comparing it to another.

Other Ways to Assign Participants
Randomized allocation: Participants are assigned randomly, like flipping a coin, to ensure fairness and reduce bias.
Non-randomized allocation: Participants are assigned based on specific factors, such as their medical condition or a doctor's decision.

How treatments are given to participants
In this study, all participants receive the same treatment. This approach is often used to evaluate the effects of a single intervention without comparing it to another.

Other Ways to Assign Treatments
Parallel assignment: Participants are split into separate groups, each receiving a different treatment.
Cross-over assignment: Participants switch between treatments during the study.
Factorial assignment: Participants receive different combinations of treatments.
Sequential assignment: Participants receive treatments one after another in a specific order, possibly based on individual responses.
Other assignment: Treatment assignment does not follow a standard or predefined design.

How the effectiveness of the treatment is controlled
In a non placebo-controlled study, no participants receive an inert substance (placebo) to compare outcomes. Instead, all participants receive either the experimental treatment or an alternative treatment (often the Standard of Care). This method allows researchers to compare the effects of the experimental treatment with those of a different active intervention, rather than a placebo.

Other Options
Placebo-Controlled: A placebo is used to compare the effects of the experimental treatment with those of an inert substance, isolating the true treatment effect.

How the interventions assigned to participants is kept confidential
Everyone involved in the study knows which treatment is being given. This is typically used when it's not possible or necessary to hide the treatment details from participants or researchers.

Other Ways to Mask Information
Single-blind: Participants do not know which treatment they are receiving, but researchers do.
Double-blind: Neither participants nor researchers know which treatment is given.
Triple-blind: Participants, researchers, and outcome assessors do not know which treatment is given.
Quadruple-blind: Participants, researchers, outcome assessors, and care providers all do not know which treatment is given.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
Any sexBiological sex of participants that are eligible to enroll.
Over 10 YearsRange of ages for which participants are eligible to join.
Healthy volunteers not allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
Maturity Onset Diabetes of the Young
Criteria
2 inclusion criteria required to participate
Diagnosis of MODY via genetic testing
HgbA1c >6.5%
12 exclusion criteria prevent from participating
History of anaphylaxis to GLP-1 receptor agonists
Already taking GLP-1 receptor agonists
on medications within the stimulant class
have had bariatric surgery

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives
One single intervention group 

is designated in this study

This study does not include a placebo group 

Treatment Groups
Group I
Experimental
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.
Study Objectives
Primary Objectives

Hemoglobin A1c

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

Glycemic patterns observed utilizing a continuous glucose monitor

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

Fasting and post meal blood serum insulin levels will be assessed

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

% body fat as identified by DXA

MRI to determine liver health

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
This study has 1 location
Recruiting
Cincinnati Children's Hospital Medical CenterCincinnati, United StatesSee the location
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One Study Center