Lowering liver fat in people with type 2 diabetes

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This parallel randomized trial will enroll 42 adults with type 2 diabetes and obesity to test whether a two-week very-low-calorie diet (~800 kcal/day) reduces liver fat and restores exercise-induced FGF21 secretion. Participants will have baseline and post-intervention MRI liver fat measurements, exercise testing with serial FGF21 sampling after about one hour of cycling at 60% VO2peak, body composition, and cardiometabolic blood markers. Participants are randomized to the VLCD or a free-living control group and changes from before to after the two-week period will be compared between groups. Secondary analyses will examine links between liver fat loss, adiponectin, and other metabolic outcomes.

Why it matters

Who can join: the full rules

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

Where it's running

• Rigshospitalet - CFAS
  Copenhagen, Capital Region, Denmark Recruiting

Study contacts

• Principal investigator: Cody G Durrer, Ph.D. — Center for Aktiv Sundhed - Rigshospitalet
• Study coordinator: Cody G Durrer, Ph.D.
• Email: cody.garett.durrer@regionh.dk
• Phone: +4550104538

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.