RecruitingNot ApplicableNCT06211556

Depletion of Liver Fat in Type 2 Diabetes

A Parallel Group Randomized Trial Investigating the Effect of Hepatic Fat Depletion Via a Very-low Calorie Diet on Hepatokine Secretion and Function in People With Type 2 Diabetes

Sponsor

Rigshospitalet, Denmark

Enrollment

42 participants

Start Date

Feb 1, 2024

Study Type

INTERVENTIONAL

Conditions

Obesity Type2diabetes

Summary

The aim of this randomized trial is to determine whether liver fat depletion via a short-term (i.e., two weeks) very-low calorie diet will restore the normal exercise-induced secretion of a signaling protein (fibroblast growth factor 21) from the liver in people living with type 2 diabetes. Participants will have their liver fat, body composition, and various markers of metabolic health assessed and then will be randomized to either the very-low calorie diet intervention or a free-living control group for two weeks. Upon completion of the two-week intervention period, participants will redo all of the pre-intervention assessments. The changes in the assessments from before vs. after the intervention period will be compared between the two intervention groups (i.e., the very-low calorie diet group vs. the free living control group).

Eligibility

Min Age: 30 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This trial is studying whether reducing fat stored in the liver can improve type 2 diabetes. Many people with type 2 diabetes also have excess liver fat, which makes it harder for the body to manage blood sugar. Researchers want to find out if targeting liver fat through diet and lifestyle changes leads to better diabetes control. **You may be eligible if...** - You are 30 to 70 years old - You have been diagnosed with type 2 diabetes - Your diabetes is managed with metformin only, or with no medication at all (or your blood sugar is still elevated despite treatment) - You have had diabetes for less than 7 years - Your body mass index (BMI) is between 30 and 40 - You currently do little to no regular exercise (less than 1.5 hours per week) **You may NOT be eligible if...** - You have type 1 diabetes, or other types such as MODY or LADA - You take any diabetes medication other than metformin (including insulin, GLP-1 drugs, or SGLT2 inhibitors) - Your kidney function is reduced (eGFR below 60) - Your blood sugar is very poorly controlled - You have significant heart, liver, or other major organ problems Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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