Depletion of Liver Fat in Type 2 Diabetes

A vizsgálat adatai

Ki végzi

Copenhagen University Hospital, Rigshospitalet

Azonosító

NCT06211556

A regiszteradat frissítve

2025. július 22.

Eredeti leírás

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).A teljes eredeti leírásKevesebb

A Parallel Group Randomized Trial Investigating the Effect of Hepatic Fat Depletion Via a Very-low Calorie Diet on Hepatokine Secretion and Function in People With Type 2 Diabetes

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).

Bevonási feltételek: 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).

Kizáró feltételek: Changes in hypothyroid disease treatment within the last 3 three months prior to enrolment; Current treatment with anti-obesity medication; Current treatment with anti-inflammatory medication; 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); Diagnosis of Type 1 diabetes, MODY-diabetes, Type 1½ diabetes or LADA-diabetes; 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; 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; Biochemical sign of other major diseases; 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); 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; Weight loss of > 5kg within the last 6 months; 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); 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.

ClinicalTrials.gov NCT06211556