Rebalancing the Fat Content of the Heart and Muscles

NCT ID: NCT07065383

Last Updated: 2025-07-15

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-08-01
• Study Completion Date: 2028-07-31

Brief Summary

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.

Detailed Description

Traditionally, diabetes therapies focus on improving glycaemic control. However, decades of well conducted clinical trials showed that glycaemic control alone has failed to reduce both all-cause and cardiovascular mortality in diabetes patients. The new diabetes treatment strategies of combining glucose control with weight reduction have heralded better cardiovascular outcomes, however their follow-up has been relatively short-term.

The investigators propose to explore the effects of semaglutide administration plus dietary counselling and physical activity encouragement versus a more intensive strategy of semaglutide administration plus a personalised and supervised program of resistance and endurance exercise training.

Conditions

Diabetes Mellitus Type 2

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Semaglutide administration plus dietary counselling and physical activity encouragement

Semaglutide administration plus dietary counselling and physical activity encouragement

Group Type: PLACEBO_COMPARATOR

Semaglutide administration plus dietary counselling and physical activity encouragement

Intervention Type: DRUG

Semaglutide administration plus dietary counselling and physical activity encouragement

Semaglutide and supervised training program

Semaglutide administration plus a personalised and supervised program of resistance and endurance training

Group Type: ACTIVE_COMPARATOR

Semaglutide plus a personalised and supervised program of resistance and endurance training

Intervention Type: DRUG

Semaglutide administration plus a personalised and supervised program of resistance and endurance training.

Interventions

Semaglutide administration plus dietary counselling and physical activity encouragement

Semaglutide administration plus dietary counselling and physical activity encouragement

Intervention Type: DRUG

Semaglutide plus a personalised and supervised program of resistance and endurance training

Semaglutide administration plus a personalised and supervised program of resistance and endurance training.

Intervention Type: DRUG

Other Intervention Names

Semaglutide with dietary counselling and physical activity encouragement; Semaglutide plus personalised and supervised resistance and endurance training program

Eligibility Criteria

Inclusion Criteria

• 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
• Current or recent (within 3 months) eGFR >30 mL/min/1.73m2)
• Able to understand written and spoken English

Exclusion Criteria

• 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)
• Blood pressure of more than 180/100 mmHg
• Patients on any other medication known to influence glucose or fatty acids metabolism (niacin, omega-3 fatty acids, other glucagon-like peptide-1 receptor agonists)
• Patients with any dietary habits that may interfere with the investigation (for example high fat vegan diets, as we know form prior research that they have very different intramyocellular fat storage compared to those on no dietary preferences)
• Patients with any history of any medical or surgical condition that in the judgement of the investigators may interfere with the exercise regime (i.e. peripheral vascular disease, arthritis), fatty acids metabolism (i.e. lipid storage diseases) or may compromise the safety of the participant (i.e. neurological syndromes for whom an intense exercise program could result in musculo-skeletal injury or accidents due to loss of balance).
• Patients with a sensitivity to Semaglutide (known hypersensitivity, diabetic retinopathy, pregnancy, history of pancreatitis or history of any cancer)
• Significant asthma or pulmonary disease
• Participants unable to cycle on the ergometer
• Unable to perform exercise testing (e.g. prosthetic limbs)
• Pregnancy, breastfeeding or considering pregnancy.
• Patients who have recently had gastrointestinal contrast or radionuclides
• Inability to lie flat or remain motionless for scanning procedures
• Patients whose girth size cannot allow them to fit in the magnetic resonance scanner (there is no set location to measure as this is different for everyone, but we have a plastic hoop that can be fitted around the largest circumference to check the fit)
• Subjects who are not able to engage into a physical training regime or feel that they do not have the interest or sustained motivation to follow one.
• Participants currently enrolled in other interventional clinical research
• Participants not able to understand written or verbal English

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

NHS Grampian

OTHER_GOV

Sponsor Role: collaborator

University of Aberdeen

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Dana Dawson, DM

Role: PRINCIPAL_INVESTIGATOR

University of Aberdeen

Central Contacts

Alexander Davidson, DM

Role: CONTACT

alexander.davidson@abdn.ac.uk

+441224559573 ext. 01224559573

Amelia E Rudd, MSc, PhD

Role: CONTACT

cardiologyresearch@abdn.ac.uk

01224559573

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Other Identifiers

3-034-24

Identifier Type: -

Identifier Source: org_study_id