Actively Recruiting
A Randomized Trial of Very-low Calorie Diet for Liver Fat Depletion and Hepatokine Function in Type 2 Diabetes
Led by Rigshospitalet, Denmark · Updated on 2025-07-22
42
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
R
Rigshospitalet, Denmark
Lead Sponsor
D
Diabetesforeningen
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are investigating whether reducing liver fat through a very-low calorie diet can restore the normal exercise-induced release of a protein called fibroblast growth factor 21 (FGF21) in people with type 2 diabetes. This protein plays a role in improving insulin sensitivity and metabolic health, but its exercise-driven secretion is impaired in those with type 2 diabetes. The trial aims to compare changes in liver fat, body composition, and metabolic markers between those following the diet and those living freely for two weeks. Participants will be randomly assigned to one of two groups: one group will follow a very-low calorie diet of about 800 calories per day for two weeks, while the other group will continue their usual lifestyle without intervention. Before and after this two-week period, all participants will undergo assessments including magnetic resonance imaging to measure liver fat, exercise tests to measure FGF21 secretion, and evaluations of cardiometabolic health. Throughout the study, participants will have their liver fat, exercise-induced FGF21 levels, body measurements, and blood markers measured before and after the intervention. The research team will monitor changes in fasting and post-exercise levels of various hormones and metabolites, as well as gene expression related to FGF21 in fat tissue. The study will last about four weeks from baseline to final assessments, including safety and metabolic evaluations to understand the impact of the diet on liver fat and metabolic function.
CONDITIONS
Brief Title
Depletion of Liver Fat in Type 2 Diabetes
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Men and women aged 30 to 70 years
- Diagnosed with type 2 diabetes managed by metformin only or without glucose-lowering medication
- HbA1c 64 mmol/mol with no glucose-lowering medications or 64 mmol/mol with metformin
- Diabetes duration less than 7 years
- Body mass index between 30 and 40 kg/m2
- Low physical activity level, defined as less than 1.5 hours of moderate exercise weekly and less than 30 minutes of daily cycling at moderate intensity
- Willing to accept medical supervision by the study endocrinologist
You will not qualify if you...
- HbA1c 75 mmol/mol without glucose-lowering medications
- HbA1c 6 mmol/mol with one glucose-lowering medication if compliant
- HbA1c 57 mmol/mol with two or more glucose-lowering medications if compliant
- Diagnosis of type 1 diabetes, MODY, type 12 diabetes, or LADA diabetes
- Estimated glomerular filtration rate (eGFR) below 60 mL/min
- Use of glucose-lowering medications other than metformin
- Presence of metal contraindicating MRI
- Moderate to severe diabetes complications (retinopathy, neuropathy, nephropathy)
- Known cancer or cardiovascular disease
- Lung disease except manageable asthma
- Thyroid disorders with recent treatment changes
- Liver disease with elevated liver enzymes
- Autoimmune diseases or psoriasis requiring systemic treatment
- Other endocrine causes of obesity
- Current anti-obesity or anti-inflammatory medication use
- Weight loss over 5 kg in past 6 months
- Recent changes in antidepressant medication or psychiatric disorders
- History of recent suicidal behavior
- Previous obesity surgery except older liposuction
- Pregnancy, lactation, or planning pregnancy
- Functional impairments preventing intensive exercise
- Participation in other intervention studies
- Macroalbuminuria or major diseases detected by screening
- Presence of GAD65 antibodies
- Contraindications for intensive exercise or study participation
- Language, mental capacity, or willingness barriers
- Unable to commit required time for the intervention
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 2 weeks
Participants are randomized to either two weeks of a very-low calorie diet or to a free-living control group.
1 baseline visit and 1 follow-up visit
Trial Site Locations
Total: 1 location
1
Rigshospitalet - CFAS
Copenhagen, Capital Region, Denmark, 2100
Actively Recruiting
Research Team
C
Cody G Durrer, Ph.D.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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