NCT06211556 Depletion of Liver Fat in Type 2 Diabetes

Eligibility & Interventions

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This trial targets 42 participants in total. It began in 2024-02-01 with a primary completion date of 2026-03.

Brief 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 Criteria

Inclusion Criteria: * 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) Exclusion Criteria: * 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) * Pregnant/considering pregnancy, or lactating * Functional impairments that prevent the performance of intensive exercise * Participation in other research intervention studies * Macroalbuminuria at pre-screening (assessed via screening blood sample) * Biochemical sign of other major diseases * Presence of circulating glutamatdecarboxylase anti body (GAD) 65 (assessed via screening blood sample) * Objective findings that contraindicate participation in intensive exercise * Incidental findings that contraindicate participation in the study * Unable to allocate the needed time to fulfill the intervention * Language barrier, mental incapacity, unwillingness, or inability to understand and be able to complete the interventions

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