Depletion of Liver Fat in Type 2 Diabetes

Recruiting now · Not applicable

Conditions studied: Type2diabetes, Obesity

In brief

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).

Key facts

Study ID

NCT06211556

Run by

Rigshospitalet, Denmark

People needed

42

Starts

2024-02-01

Expected to finish

2026-03-01

Last updated by the study team

2025-07-22

Who can join

Age: 30 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

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)
• Known cancer
• Lung disease, other than asthma that can be managed with beta2-agonists and does not exhibit seasonal variation
• Known cardiovascular disease
• Known hyperthyroid disease
• Clinical or biochemical signs of hypothyroid disease
• Changes in hypothyroid disease treatment within the last 3 three months prior to enrolment
• Known liver disease - defined as ALAT or ASAT elevated three times above upper limit
• Known autoimmune disease
• Psoriasis disease requiring systemic treatment or cutan elements bigger than a total area of 25 cm2
• Other endocrine disorder causing obesity
• Current treatment with anti-obesity medication
• Current treatment with anti-inflammatory medication
• Weight loss of > 5kg within the last 6 months
• Changes in symptoms or anti-depressive medication three months prior to enrolment
• Diagnosis of psychiatric disorder or treatment with anti-psychotic medication
• History of suicidal behavior or ideations within the last three months prior enrolment
• Previous surgical treatment for obesity (excluding liposuction > 1 year prior to enrolment)

Where it is running

• Rigshospitalet - CFAS — Copenhagen, Capital Region, Denmark (enrolling)

Full record on ClinicalTrials.gov

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