Status:
RECRUITING
Depletion of Liver Fat in Type 2 Diabetes
Lead Sponsor:
Rigshospitalet, Denmark
Collaborating Sponsors:
Diabetesforeningen
Canadian Institutes of Health Research (CIHR)
Conditions:
Type2diabetes
Obesity
Eligibility:
All Genders
30-70 years
Phase:
NA
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 ...
Detailed Description
Fibroblast growth factor 21 (FGF21) is a hepatokine that confers multiple beneficial effects when signaling to other tissues in the body. This is particularly true in adipose tissue, where it improves...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2026
Estimated Enrollment :
42 Patients enrolled
Trial Details
Trial ID
NCT06211556
Start Date
February 1 2024
End Date
March 1 2026
Last Update
July 22 2025
Active Locations (1)
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1
Rigshospitalet - CFAS
Copenhagen, Capital Region, Denmark, 2100