Depletion of Liver Fat in Type 2 Diabetes

Launched by RIGSHOSPITALET, DENMARK · Jan 8, 2024

Keywords

ClinConnect Summary

This clinical trial is looking to see if a very low-calorie diet for two weeks can help reduce fat in the liver of people with type 2 diabetes. The goal is to find out if this diet can improve the way the liver releases a protein that plays a role in metabolism and exercise. Participants will be divided into two groups: one group will follow the low-calorie diet, while the other will continue with their usual eating habits. Before and after the two weeks, the researchers will measure liver fat, body composition, and other health markers to see how the different diets affect these factors.

To be eligible for this trial, participants must be between 30 and 70 years old and diagnosed with type 2 diabetes, either managing it with metformin or without any medication. They should also have a body mass index (BMI) between 30 and 40 and not engage in much physical activity. However, there are certain medical conditions and medications that could prevent someone from participating, such as severe diabetes complications, certain cancers, or treatments other than metformin for diabetes. Overall, this study aims to understand better how dietary changes can impact liver health and metabolic function in individuals with type 2 diabetes.

Gender

ALL

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