Actively Recruiting
Depletion of Liver Fat in Type 2 Diabetes
Led by Rigshospitalet, Denmark · Updated on 2025-07-22
42
Participants Needed
1
Research Sites
108 weeks
Total Duration
On this page
Sponsors
R
Rigshospitalet, Denmark
Lead Sponsor
D
Diabetesforeningen
Collaborating Sponsor
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
Depletion of Liver Fat in Type 2 Diabetes
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Men and women 30-70 years of age
- Diagnosed with type 2 diabetes managed only with metformin or no glucose-lowering medications
- HbA1c 64 mmol/mol with or without glucose-lowering medications
- Diabetes duration less than 7 years
- Body mass index (BMI) between 30 and 40 kg/m2
- Accepts medical regulation by the study endocrinologist
- Less than 1.5 hours of moderate intensity structured physical activity per week and less than 30 minutes of moderate intensity cycling per day
You will not qualify if you...
- HbA1c 75 mmol/mol without glucose-lowering medications
- HbA1c 64 mmol/mol with mono glucose-lowering therapy
- HbA1c 57 mmol/mol with dual glucose-lowering therapy
- Diagnosis of Type 1 diabetes, MODY, Type 1 diabetes or LADA
- Estimated glomerular filtration rate (eGFR) less than 60 mL/min
- Treatment with glucose-lowering medications other than metformin
- Presence of metal contraindicating MRI
- Known or signs of severe microvascular complications
- Known cancer
- Lung disease other than manageable asthma
- Known cardiovascular disease
- Known hyperthyroid or recent changes in hypothyroid treatment
- Known liver disease with elevated liver enzymes
- Known autoimmune disease
- Psoriasis requiring systemic treatment or large skin involvement
- Other endocrine disorders causing obesity
- Current anti-obesity or anti-inflammatory medication
- Weight loss over 5 kg in past 6 months
- Recent changes in anti-depressive medication
- Psychiatric disorders or recent suicidal behavior
- Previous obesity surgery except liposuction over 1 year ago
- Pregnant, lactating, or planning pregnancy
- Functional impairments preventing intensive exercise
- Participation in other intervention studies
- Macroalbuminuria or other major diseases
- Presence of GAD65 antibodies
- Contraindications to intensive exercise
- Inability to commit time or understand the study due to language or mental issues
AI-Screening
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Trial Site Locations
Total: 1 location
1
Rigshospitalet - CFAS
Copenhagen, Capital Region, Denmark, 2100
Actively Recruiting
Research Team
C
Cody G Durrer, Ph.D.
CONTACT
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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