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New treatment option for Type2diabetes
Official title Depletion of Liver Fat in Type 2 Diabetes
ClinicalTrials.gov ID: NCT06211556
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 30 to 70
You may be able to join if
- 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...
You likely can't join if
- , 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...
- HbA1c ≥ 75 mmol/mol with no glucose lowering medications
See the full eligibility 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...
- , 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)...
- 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Copenhagen, Capital Region, Denmark
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 30 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Copenhagen, Capital Region, Denmark. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.