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Re-CHARM

RecruitingPhase NA

Rebalancing the Fat Content of the Heart and Muscles

Intramyocellular Lipid Compartments After Glucagon-like Peptide 1 Receptor Agonist Therapy in Type 2 Diabetes - Rebalancing the Fat Content of the Heart and Muscles

Assets

GLP-1 / incretin class catch-all / Semaglutide

Listed sites

1

Recruiting sites

1

Enrollment

60

estimated

Study population

Obesity / overweight, Type 2 diabetes

Key I/E criteria

BMI ≥27eGFR ≥30

Primary endpoint

1H-magnetic resonance spectroscopy

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT07065383
Org study ID3-034-24

Timeline

Milestones

Study first posted2025-07-15actual
Study start2025-08-01actual
Last update posted2026-04-30actual
Primary completion2028-07-31estimated
Study completion2028-07-31estimated

Assets

Investigational agents

Study populations

Who this study enrolls

Obesity / overweightType 2 diabetes

Eligibility

Who can enroll

Minimum age20 Years
Maximum age75 Years
SexAll
Healthy volunteersNot accepted

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

Endpoints (2)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Weight & body composition
1
Other (unclassified)
1

Weight & body composition

1 endpoint
Primary/protocol endpoint

1H-magnetic resonance spectroscopy

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

change from baseline, improvement

Other (unclassified)

1 endpoint
Secondary/protocol endpoint/low confidence

Intramyocellular lipid pool compartments

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

descriptive

Publications (25)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 1, 2026
Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)
Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.