Depletion of Liver Fat in Type 2 Diabetes
Eligible age
30–70 yrs
Accepts
All genders
Locations
0 states
Healthy volunteers
No
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About this study
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).
Sponsor: Rigshospitalet, Denmark
You may qualify if…
- ✓ Men and women 30-70 years of age
- ✓ The target population is persons with type 2 diabetes. I.e., persons are eligible if they are diagnosed with type 2 diabetes either only with metformin for managing glucose or without use of glucose lowering medications. Persons with a HbA1c ≥ 48 mmol/mol with or without the use of glucose lowering medications are also eligible. Any glucose lowering medications other than metformin are disallowed (described under "Exclusion criteria, below)
- ✓ Diabetes duration \< 7 years
- ✓ Body Mass Index (BMI) ≥ 30 kg/m2 and ≤ 40 kg/m2
- ✓ Accepts medical regulation by the study endocrinologist
- ✓ Inactivity, defined as \< 1,5 hours of structured physical activity pr. week at moderate intensity and cycling \< 30 minutes/5 km pr. day at moderate intensity (moderate intensity = out of breath but able to speak)
You may not qualify if…
- ✕ HbA1c ≥ 75 mmol/mol with no glucose lowering medications
- ✕ HbA1c ≥ 64 mmol/mol with mono glucose lowering therapy (if compliant with the prescription)
- ✕ HbA1c ≥ 57 mmol/mol with ≥ dual glucose lowering therapy (if compliant with the prescription)
- ✕ Diagnosis of Type 1 diabetes, MODY-diabetes, Type 1½ diabetes or LADA-diabetes
- ✕ eGFR\<60mL/min (assessed via screening blood sample)
- ✕ Treatment with any glucose-lowering medications other than metformin (e.g., insulin (long and/or short acting), sulphonylurea based drugs, glucagon-like peptide 1 receptor agonists, dipeptidyl peptidase 4 inhibitors, sodium-glucose co-transporter-2 inhibitors, thiazolidinediones, alpha-glucosidase inhibitors)
- ✕ Presence of metal in the body that would contraindicate an MRI scan
- ✕ Known or signs of intermediate or severe microvascular complications to diabetes (retino-, neuro- or nephropathy)
Source: ClinicalTrials.gov · NCT06211556 · last updated 2025-07-22