Rebalancing the Fat Content of the Heart and Muscles

ConditionDiabetes Mellitus Type 2

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age20-75

SponsorUniversity of Aberdeen

About this trial

Traditional diabetes therapies focus on improving blood sugar control. However, many studies show that this may not be enough. New treatments focusing on weight loss have heralded better results. One of these treatments is Semaglutide and the investigators wish to examine its effects further in this study. The investigators propose to investigate what happens to the fat inside the heart and the leg muscles.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients with a confirmed diagnosis of type 2 diabetes established in the previous 10 years between the ages of 20 and 75

HbA1c ≥ 53 mmol/mol (7%) typically on diet and/or metformin/sulphonylureas (and/or sodium-glucose cotransporter-2 inhibitors, Dipeptidyl peptidase 4 inhibitors, thiazolidinediones, but not on insulin)

Patients who do not meet the WHO recommendations on physical activity (≤150 minutes per week) of moderate-vigorous physical activity (MVPA)

Patients who have a BMI of ≥27 but with a body weight of less than 140kgs due to limitations of the scanner table weight limit

Disqualifiers

Any previously unknown cardiac condition other than mild valvular disease

Any history of known coronary artery disease (including myocardial infarction and myocardial infarction with normal coronary arteries)

Any relevant or untreated endocrine condition (i.e. Cushings)

Impaired renal function (defined as estimated glomerular filtration rate of less than 30 mL/min/1.73m2)

Trial design

Design model

Parallel

Treatments tested in this trial

Semaglutide administration plus dietary counselling and physical activity encouragement
Drug
Semaglutide administration plus dietary counselling and physical activity encouragement
Semaglutide plus a personalised and supervised program of resistance and endurance training
Drug
Semaglutide administration plus a personalised and supervised program of resistance and endurance training.

Treatment groups

60 Participants

are divided into 2 treatment groups

Group A: Semaglutide administration plus dietary counselling and physical activity encouragementPlacebo comparator 1 intervention

Group B: Semaglutide and supervised training programActive comparator 1 intervention

Trial outcomes

Primary outcomes

1H-magnetic resonance spectroscopy

Non-invasive proton magnetic resonance spectroscopy (1H MRS) for assessment to determine the total intramyocellular fat

Time frame

From enrollment to the end of treatment at the end of 12 weeks

Secondary outcomes

Intramyocellular lipid pool compartments

Intramyocellular Lipid pool compartments examined with non-invasive proton magnetic resonance spectroscopy (1H MRS) and turnover examined with stable isotopes

Time frame

From enrollment to the end of treatment at the end of 12 weeks

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Aberdeen

Lead sponsor

NHS Grampian

Collaborator

Source ClinicalTrials.gov

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