Active, not recruitingNot applicableObservational
What this study is about
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: 1. Is chronic hyperglycemia in type 1 and 2 diabetes associated with functional and structural deficits of skeletal muscles unrelated to the presence of neuropathy? 2. Is obesity associated with functional and structural impairments of skeletal muscles unrelated to the presence of type 2 diabetes ? 3. 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 diabetes Study 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.
A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.
Basic eligibility
Age18 Years to 60 Years
SexAll
Healthy volunteersAccepted
ConditionDiabetes Mellitus, Obesity, Chronic Hyperglycaemia, Weight Loss, Diabetic Myopathy, Sarcopenia
Full registry criteria
Inclusion Criteria: Study 1: * Age: 18-60 years * BMI: 18.5 - 39, minimum weight = 50kg * Chronic hyperglycemia: HbA1c of ≥ 70 mmol/mol with a duration of ≥ 2 months prior to enrollment * Physical activity: Less than 3 x 60 min of structured physical activity per week Study 2 \& 3: * Age: 25-60 years * BMI: ≥ 35 * Physical activity: Less than 3 x 60 min of structured physical activity per week Healthy Control Participants: * Age: 18-60 years * BMI: 18.5 - 30, minimum weight = 50kg * Physical activity: Less than 3 x 60 min of structured physical activity per week Exclusion Criteria: Study 1, 2, 3 and healthy controls: * Diabetic neuropathy with expected motor deficits * Uncontrolled 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 contraindications * Any condition that by the principal investigator is expected to affect the participants ability to execute the study elements Specifically for healthy control participants: * The presence of diabetes or pre-diabetes (HbA1c ≥42 mmol/mol)
Treatments and study arms
6-months of medically assisted glycemic improvement
Drug
Administrated by the clinic at Steno Diabetes Center, Aarhus, Denmark
Bariatric surgery
Procedure
Participants are examined prior to and 1 year following bariatric surgery in the Central Region, Denmark
Primary outcomes
Baseline: Evaluating the presence of sarcopenia in relation to the presence of hyperglycemia and/or obesityThe prevalence of sarcopenia in participants with diabetes and hyperglycemia (study 1) or obesity (study 2) as compared to healthy control participants at baselineThe presence of sarcopenia is assessed based on recommended methods including measures of muscle strength (Biodex Dynamometer), muscle quantity and quality (MRI), and physical performance tests.
Baseline: Skeletal muscle Force-velocity assessment in relation to the presence of hyperglycemia and/or obesityThe force-velocity relationship in participants with diabetes and hyperglycemia (study 1) or obesity (study 2) as compared to healthy control participants at baselineAssessed by isokinetic knee-extension and dorsal flexion on a Biodex Dynamometer at increasing angular-velocities
Baseline: Assessment of skeletal muscle fatigue in relation to the presence of hyperglycemia and/or obesityFatigue in participants with diabetes and hyperglycemia (study 1) or obesity (study 2) as compared to healthy control participants at baselineAssessed by a fatiguing isotonic protocol for knee-extension and dorsal flexion on a Biodex Dynamometer including twitch-parameters of knee-extensors
Changes in skeletal muscle force-velocity relationship with weight-loss or glycemic improvementChange from baseline to follow-up at an average of 6 months for study 1 and 12 months for study 3
Changes in skeletal muscle fatigue in relation to weight-loss or glycemic improvementChange from baseline to follow-up at an average of 6 months for study 1 and 12 months for study 3
Changes in parameters defining sarcopenia in relation to weight-loss or glycemic improvementChange from baseline to follow-up at an average of 6 months for study 1 and 12 months for study 3
Study locations
1 locations were listed when this page was built. The first 40 are shown.
Aarhus University Hospital, Denmark🇩🇰 Aarhus, Aarhus, Denmark 