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New treatment option for Diabetes Mellitus Type 2
Official title Rebalancing the Fat Content of the Heart and Muscles
ClinicalTrials.gov ID: NCT07065383
What this study is testing
What is Semaglutide administration plus dietary counselling and physical activity encouragement?
Semaglutide administration plus dietary counselling and physical activity encouragement is an investigational medicine, being studied as a potential treatment for diabetes mellitus type 2.
Also referred to as Semaglutide with dietary counselling and physical activity encouragement.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Traditional diabetes therapies focus on improving blood sugar control. However, many studies show that this may not be enough.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 20 to 75
You may be able to join if
- 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...
- 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)
You likely can't join if
- 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...
See the full eligibility 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
- 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...
- 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...
- 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...
- people 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 treatment clinical research
- Participants not able to understand written or verbal English
The study team makes the final eligibility decision.
Where it's taking place
- Aberdeen, Aberdeenshire, United Kingdom
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 20 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Aberdeen, Aberdeenshire, United Kingdom. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.