Depletion of Liver Fat in Type 2 Diabetes
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
Rigshospitalet, Denmark
42 participants
Feb 1, 2024
INTERVENTIONAL
Conditions
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
Inclusion Criteria1
- Men and women 30-70 years of age
Exclusion Criteria39
- 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)
- 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
Interventions
\~800 kcal/day delivered via commercially available diet plan (NUPO).
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06211556