Type 1 Diabetes for Fatty Liver Disease

(AGL14 Trial)

Overseen By Frédérique Frisch

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Université de Sherbrooke

Must be taking: Insulin

Must not be taking: Lipid-lowering, Carbohydrate-metabolism

Disqualifiers: Cardiovascular, Liver, Renal, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to understand how type 1 diabetes affects fat storage in the liver, potentially leading to liver disease and increasing risks for heart, kidney, and eye problems. Researchers will conduct a 9-hour study to observe how the body processes food in individuals with and without type 1 diabetes. The trial seeks participants with type 1 diabetes who use an insulin pump and have abdominal obesity, as well as individuals with normal blood sugar levels who match in age and body size. As an unphased trial, this study offers participants the opportunity to contribute to important research that may enhance future diabetes care.

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores how people with and without Type 1 Diabetes process food in relation to fatty liver disease. Unlike traditional treatments for fatty liver disease, which often focus on lifestyle changes or medications targeting liver enzymes, this study aims to understand the metabolic differences in both groups over a 9-hour period after eating. By examining these differences, scientists hope to uncover new insights that could lead to more effective, personalized treatments for managing fatty liver disease in people with and without Type 1 Diabetes.

Who Is on the Research Team?

André C Carpentier, MD

Principal Investigator

Université de Sherbrooke

Are You a Good Fit for This Trial?

This trial is for individuals with Type 1 Diabetes who also have abdominal obesity and fatty liver disease, including non-alcoholic fatty liver disease. Participants should be experiencing excess fat storage in the liver due to their condition.

Inclusion Criteria

I have normal blood sugar levels, and match the study's requirements for sex, age, waist size, and menopausal status.

I have Type 1 Diabetes and abdominal obesity, and use an insulin pump with glucose monitoring.

Exclusion Criteria

Current or planned pregnancy within the next 6 months

Being allergic to eggs

Any contraindication to MRI

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Metabolic Visit

Participants undergo a 9-hour postprandial metabolic study including test meal, perfusion of stable tracers, blood sampling, PET and MRI acquisitions

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after the metabolic visit

4 weeks

What Are the Treatments Tested in This Trial?

Trial Overview The study investigates how abnormal fat function in Type 1 Diabetes contributes to liver fat. It uses PET/MRI imaging, stable isotope infusions, indirect calorimetry, and meal tests to assess metabolic functions and fat deposits.

How Is the Trial Designed?

Group I: Group without Type 1 Diabetes Experimental Treatment 4 Interventions

Participants will undergo a 9-hour postprandial metabolic study

Group II: Group with Type 1 Diabetes Experimental Treatment 4 Interventions

Participants will undergo a 9-hour postprandial metabolic study

Who Is Running the Clinical Trial?

Université de Sherbrooke

Lead Sponsor

Trials

317

Recruited

79,300+

Centre de recherche du Centre hospitalier universitaire de Sherbrooke

Collaborator

Trials

64

Recruited

33,600+