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Recruiting NCT05685927

Muscular Deficits of Diabetic Myopathy

Conditions: Diabetes Mellitus, Obesity, Chronic Hyperglycaemia, Weight Loss, Diabetic Myopathy, Sarcopenia

Sex: All
Ages: 18 Years – 60 Years
Healthy volunteers: 1
Enrollment: 108
Sponsor: University of Aarhus

Location: Denmark

Summary

The goal of this observational study is to assess if diabetes and obesity are independently related to functional and structural muscle deficits, and how muscular deficits relate to metabolic properties of diabetes and obesity. All studies will include clinical muscle strength and contractile examinations, functional tests, and MR imaging and spectroscopy techniques.The main questions this project aims to answer are:Is chronic hyperglycemia in type 1 and 2 diabetes associated with functional and structural deficits of skeletal muscles unrelated to the presence of neuropathy?Is obesity associated with functional and structural impairments of skeletal muscles unrelated to the presence of type 2 diabetes ?Does weight loss improve muscle metabolic flexibility and economy and modify skeletal muscle function and structure in obese subjects with and without type 2 diabetes?The project will include three studies, intended to answer the hypotheses listed above:Study 1: Evaluation of functional and structural muscular deficits of diabetic myopathy in relation to prolonged hyperglycemia prior to and 6 months following glycemic improvement in patients with type 1 and 2 diabetesStudy 2: Functional and structural muscular deficits in severely obese subjects with and without type 2 diabetes prior to assisted weight loss.Study 3: Changes in functional and structural muscle properties following assisted weight loss in severely obese subjects with and without type 2 diabetes - a 1-year follow-up study.

Eligibility Criteria

Inclusion Criteria:Study 1:Age: 18-60 yearsBMI: 18.5 - 27, minimum weight = 50kgChronic hyperglycemia: HbA1c of ≥ 70 mmol/mol with a duration of ≥ 2 monthsPhysical activity: Less than 3 x 60 min of structured physical activity per weekStudy 2 & 3:Age: 25-60 yearsBMI: ≥ 35Physical activity: Less than 3 x 60 min of structured physical activity per weekHealthy Control Participants:Age: 18-60 yearsBMI: 18.5 - 27, minimum weight = 50kgPhysical activity: Less than 3 x 60 min of structured physical activity per weekExclusion Criteria:Study 1, 2, 3 and healthy controls:Diabetic neuropathyUncontrolled cardiovascular or pulmonary disease, peripheral vascular disease, osteoarthropathy of the lower extremity, or any neurological og rheumatological disease which may affect muscle function, as well as any other disease that may effect ones ability to perform physical activity.Any Magnetic Resonance contraindicationsAny condition that by the principal investigator is expected to affect the participants ability to execute the study elementsSpecifically for healthy control participants:The presence of diabetes or pre-diabetes (HbA1c ≥42 mmol/mol)

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05685927). StuddyBuddy aggregates publicly available trial information.