AzTrials
AzTrials

Diabetes Mellitus Type 2Re-CHARMNCT07065383

Rebalancing the Fat Content of the Heart and Muscles

A study testing Semaglutide administration plus dietary counselling and physical activity encouragement and Semaglutide plus a personalised and supervised program of resistance and endurance training in people with Diabetes Mellitus Type 2, run by University of Aberdeen at 1 site in United Kingdom.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 20 to 75 years
Conditions the study is for
Diabetes Mellitus Type 2
What is being tested?
Semaglutide administration plus dietary counselling and physical activity encouragement and Semaglutide plus a personalised and supervised program of resistance and endurance training
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
60 participants
Where
1 siteUnited Kingdom
Study dates
1 Aug 2025to 31 Jul 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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)
Show all 19Show fewer
  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

United Kingdom1 site, 1 recruiting
  • Cardiac Research Office, Aberdeen Royal Infirmary

    Aberdeen, Aberdeenshire, AB25 2ZD

    Dana Dawson, PhD, 01224 437969, dana.dawson@abdn.ac.uk

    Amelia Rudd, HND, 01224 559573, a.e.rudd@abdn.ac.uk

    Recruiting

Other trials in United Kingdom

About this study

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

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.

Read the 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.

Being tested
Semaglutide administration plus dietary counselling and physical activity encouragement, Semaglutide plus a personalised and supervised program of resistance and endurance training
Medical subject headings
Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Semaglutide administration plus dietary counselling and physical activity encouragementDrug

    Also called Semaglutide with dietary counselling and physical activity encouragement

    Semaglutide administration plus dietary counselling and physical activity encouragement

  • Semaglutide plus a personalised and supervised program of resistance and endurance trainingDrug

    Also called Semaglutide plus personalised and supervised resistance and endurance training program

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

Study groups in NCT07065383
Study groupRoleWhat they receive
Semaglutide administration plus dietary counselling and physical activity encouragementPlacebo comparatorSemaglutide administration plus dietary counselling and physical activity encouragement
Receives: Drug: Semaglutide administration plus dietary counselling and physical activity encouragement
Semaglutide and supervised training programActive comparatorSemaglutide administration plus a personalised and supervised program of resistance and endurance training
Receives: Drug: Semaglutide plus a personalised and supervised program of resistance and endurance training

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 1H-magnetic resonance spectroscopy

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

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

Secondary outcomes (1)
  1. Intramyocellular lipid pool compartments

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

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Jul 2025
  2. Study start1 Aug 2025
  3. Primary completion31 Jul 2028 (estimated)
  4. Study completion31 Jul 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Basic science
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07065383
Sponsor's protocol ID
3-034-24
Acronym
Re-CHARM
Status last verified
Jul 2025
First submitted
24 Jun 2025
Last updated
30 Apr 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Anonymised data will be made available through request at time of publication depending on journal requirements.

Publications

  • Rodriguez-Gutierrez R, Montori VM. Glycemic Control for Patients With Type 2 Diabetes Mellitus: Our Evolving Faith in the Face of Evidence. Circ Cardiovasc Qual Outcomes. 2016 Sep;9(5):504-12. doi: 10.1161/CIRCOUTCOMES.116.002901. Epub 2016 Aug 23.

    PubMed 27553599
  • von Gerichten J, West AL, Irvine NA, Miles EA, Calder PC, Lillycrop KA, Fielding BA, Burdge GC. The Partitioning of Newly Assimilated Linoleic and alpha-Linolenic Acids Between Synthesis of Longer-Chain Polyunsaturated Fatty Acids and Hydroxyoctadecaenoic Acids Is a Putative Branch Point in T-Cell Essential Fatty Acid Metabolism. Front Immunol. 2021 Oct 5;12:740749. doi: 10.3389/fimmu.2021.740749. eCollection 2021.

    PubMed 34675928
  • Burdge GC, Wright P, Jones AE, Wootton SA. A method for separation of phosphatidylcholine, triacylglycerol, non-esterified fatty acids and cholesterol esters from plasma by solid-phase extraction. Br J Nutr. 2000 Nov;84(5):781-7.

    PubMed 11177194
  • FOLCH J, LEES M, SLOANE STANLEY GH. A simple method for the isolation and purification of total lipides from animal tissues. J Biol Chem. 1957 May;226(1):497-509. No abstract available.

    PubMed 13428781
  • Johnson NA, Walton DW, Sachinwalla T, Thompson CH, Smith K, Ruell PA, Stannard SR, George J. Noninvasive assessment of hepatic lipid composition: Advancing understanding and management of fatty liver disorders. Hepatology. 2008 May;47(5):1513-23. doi: 10.1002/hep.22220.

    PubMed 18393289
  • Boesch C, Slotboom J, Hoppeler H, Kreis R. In vivo determination of intra-myocellular lipids in human muscle by means of localized 1H-MR-spectroscopy. Magn Reson Med. 1997 Apr;37(4):484-93. doi: 10.1002/mrm.1910370403.

    PubMed 9094069
  • Scally C, Abbas H, Ahearn T, Srinivasan J, Mezincescu A, Rudd A, Spath N, Yucel-Finn A, Yuecel R, Oldroyd K, Dospinescu C, Horgan G, Broadhurst P, Henning A, Newby DE, Semple S, Wilson HM, Dawson DK. Myocardial and Systemic Inflammation in Acute Stress-Induced (Takotsubo) Cardiomyopathy. Circulation. 2019 Mar 26;139(13):1581-1592. doi: 10.1161/CIRCULATIONAHA.118.037975.

    PubMed 30586731
  • Wallace TM, Levy JC, Matthews DR. Use and abuse of HOMA modeling. Diabetes Care. 2004 Jun;27(6):1487-95. doi: 10.2337/diacare.27.6.1487.

    PubMed 15161807
  • Fillmer A, Hock A, Cameron D, Henning A. Non-Water-Suppressed 1H MR Spectroscopy with Orientational Prior Knowledge Shows Potential for Separating Intra- and Extramyocellular Lipid Signals in Human Myocardium. Sci Rep. 2017 Dec 4;7(1):16898. doi: 10.1038/s41598-017-16318-0.

    PubMed 29203776
  • Blundell J, Finlayson G, Axelsen M, Flint A, Gibbons C, Kvist T, Hjerpsted JB. Effects of once-weekly semaglutide on appetite, energy intake, control of eating, food preference and body weight in subjects with obesity. Diabetes Obes Metab. 2017 Sep;19(9):1242-1251. doi: 10.1111/dom.12932. Epub 2017 May 5.

    PubMed 28266779
  • Wilding JPH, Batterham RL, Calanna S, Davies M, Van Gaal LF, Lingvay I, McGowan BM, Rosenstock J, Tran MTD, Wadden TA, Wharton S, Yokote K, Zeuthen N, Kushner RF; STEP 1 Study Group. Once-Weekly Semaglutide in Adults with Overweight or Obesity. N Engl J Med. 2021 Mar 18;384(11):989-1002. doi: 10.1056/NEJMoa2032183. Epub 2021 Feb 10.

    PubMed 33567185
  • Lincoff AM, Brown-Frandsen K, Colhoun HM, Deanfield J, Emerson SS, Esbjerg S, Hardt-Lindberg S, Hovingh GK, Kahn SE, Kushner RF, Lingvay I, Oral TK, Michelsen MM, Plutzky J, Tornoe CW, Ryan DH; SELECT Trial Investigators. Semaglutide and Cardiovascular Outcomes in Obesity without Diabetes. N Engl J Med. 2023 Dec 14;389(24):2221-2232. doi: 10.1056/NEJMoa2307563. Epub 2023 Nov 11.

    PubMed 37952131
  • Marso SP, Bain SC, Consoli A, Eliaschewitz FG, Jodar E, Leiter LA, Lingvay I, Rosenstock J, Seufert J, Warren ML, Woo V, Hansen O, Holst AG, Pettersson J, Vilsboll T; SUSTAIN-6 Investigators. Semaglutide and Cardiovascular Outcomes in Patients with Type 2 Diabetes. N Engl J Med. 2016 Nov 10;375(19):1834-1844. doi: 10.1056/NEJMoa1607141. Epub 2016 Sep 15.

    PubMed 27633186
  • Iacobellis G. Epicardial adipose tissue in contemporary cardiology. Nat Rev Cardiol. 2022 Sep;19(9):593-606. doi: 10.1038/s41569-022-00679-9. Epub 2022 Mar 16.

    PubMed 35296869
  • Dube JJ, Amati F, Stefanovic-Racic M, Toledo FG, Sauers SE, Goodpaster BH. Exercise-induced alterations in intramyocellular lipids and insulin resistance: the athlete's paradox revisited. Am J Physiol Endocrinol Metab. 2008 May;294(5):E882-8. doi: 10.1152/ajpendo.00769.2007. Epub 2008 Mar 4.

    PubMed 18319352

Questions about this trial

What is this clinical trial studying?

A study testing Semaglutide administration plus dietary counselling and physical activity encouragement and Semaglutide plus a personalised and supervised program of resistance and endurance training in people with Diabetes Mellitus Type 2, run by University of Aberdeen at 1 site in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 30 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Alexander Davidson, DM (+441224559573 ext. 01224559573, alexander.davidson@abdn.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

1H-magnetic resonance spectroscopy (time frame: From enrollment to the end of treatment at the end of 12 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07065383, which also lists 25 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2026.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in