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Trial · Interventional

RecruitingNot applicableRegistry data

Rebalancing the Fat Content of the Heart and Muscles

Short name Re-CHARM

Overview

Status
Recruiting
Phase
Not applicable
Enrollment
60 participants (estimated)
Sponsor
University of Aberdeen · Other
Design
Randomized · Open label (no masking)
Countries
1 country

United Kingdom

Start
1 Aug 2025
Primary completion
31 Jul 2028 (estimated)
Completion
31 Jul 2028 (estimated)
First posted
15 Jul 2025
Last update posted
30 Apr 2026
Conditions
Diabetes Mellitus Type 2

Timeline

1 trial · 1 ongoing

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
20252026202720282029
  1. N/A

    Re-CHARM

    NCT07065383

    1 Aug 2025 to est. 31 Jul 2028

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • Semaglutide administration plus dietary counselling and physical activity encouragementDrug
  • Semaglutide plus a personalised and supervised program of resistance and endurance trainingDrug

Arms2

  • Placebo comparator

    Semaglutide administration plus dietary counselling and physical activity encouragement

    Semaglutide administration plus dietary counselling and physical activity encouragement

  • Active comparator

    Semaglutide and supervised training program

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

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. 1H-magnetic resonance spectroscopy

    Time frame · From enrollment to the end of treatment at the end of 12 weeks

    Registry description

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

Secondary outcomes(1)
  1. Intramyocellular lipid pool compartments

    Time frame · From enrollment to the end of treatment at the end of 12 weeks

    Registry description

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

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

A trial that is still running, or that stopped early, may post results later.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies4

Studies that cite this trial.

Studies with results

4 studies on this page

Indexing hint: Randomized controlled trial · 2023

2 results

Semaglutide and Cardiovascular Outcomes in Obesity without Diabetes.

Lincoff et al. 2023The New England journal of medicinecited by 2,458

PMID 37952131DOI 10.1056/nejmoa2307563PUB-37952131

Rights unknown2 results

Indexing hint: Randomized controlled trial · 2021

10 results

Once-Weekly Semaglutide in Adults with Overweight or Obesity.

Wilding et al. 2021The New England journal of medicinecited by 3,862

PMID 33567185DOI 10.1056/nejmoa2032183PUB-33567185

Full text at the publisher10 results

Indexing hint: Randomized controlled trial · 2017

13 results

Effects of once-weekly semaglutide on appetite, energy intake, control of eating, food preference and body weight in subjects with obesity.

Blundell et al. 2017Diabetes, obesity & metabolismcited by 539

PMID 28266779PMC5573908DOI 10.1111/dom.12932PUB-28266779

Free to read · publisher termsCC BY-NC-ND13 results

Indexing hint: Randomized controlled trial · 2016

8 results

Semaglutide and Cardiovascular Outcomes in Patients with Type 2 Diabetes.

Marso et al. 2016The New England journal of medicinecited by 5,002

PMID 27633186DOI 10.1056/nejmoa1607141PUB-27633186

Rights unknown8 results

Eligibility

Who could join, as posted.

Sex
All
Age
from 20 Years up to 75 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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

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