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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Non-obese participants with dysregulated type 1 diabetes |
| ||
| Non-obese participants with dysregulated type 2 diabetes |
| ||
| Obese participants with type 2 diabetes |
| ||
| Obese participants without type 2 diabetes |
| ||
| Healthy control participants |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 6-months of medically assisted glycemic improvement | Drug | Administrated by the clinic at Steno Diabetes Center, Aarhus, Denmark |
|
| Measure | Description | Time Frame |
|---|---|---|
| Baseline: Evaluating the presence of sarcopenia in relation to the presence of hyperglycemia and/or obesity | The 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. | The prevalence of sarcopenia in participants with diabetes and hyperglycemia (study 1) or obesity (study 2) as compared to healthy control participants at baseline |
| Baseline: Skeletal muscle Force-velocity assessment in relation to the presence of hyperglycemia and/or obesity | Assessed by isokinetic knee-extension and dorsal flexion on a Biodex Dynamometer at increasing angular-velocities | The force-velocity relationship in participants with diabetes and hyperglycemia (study 1) or obesity (study 2) as compared to healthy control participants at baseline |
| Baseline: Assessment of skeletal muscle fatigue in relation to the presence of hyperglycemia and/or obesity | Assessed by a fatiguing isotonic protocol for knee-extension and dorsal flexion on a Biodex Dynamometer including twitch-parameters of knee-extensors | Fatigue in participants with diabetes and hyperglycemia (study 1) or obesity (study 2) as compared to healthy control participants at baseline |
| Changes in skeletal muscle force-velocity relationship with weight-loss or glycemic improvement | Change 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 improvement | Change 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 improvement |
| Measure | Description | Time Frame |
|---|---|---|
| 31P MRS: Skeletal muscle bioenergetics and metabolic economy | Assessed by phosphorus magnetic resonance spectroscopy (31P MRS) performed during an isotonic fatiguing exercise in a 3T MR-scanner | Bioenergetics and metabolic economy in participants with diabetes and hyperglycemia (study 1) or obesity (study 2) as compared to healthy control participants at baseline |
| Measure | Description | Time Frame |
|---|---|---|
| EMG assessment of myopathic changes | Will be assessed in knee extensors and/or dorsal flexors on a subgroup of participants demonstrating significant fatigue during primary measures | Change from baseline to follow-up at an average of 6 months for study 1 and 12 months for study 3 |
Inclusion Criteria:
Study 1:
Study 2 & 3:
Healthy Control Participants:
Exclusion Criteria:
Study 1, 2, 3 and healthy controls:
Specifically for healthy control participants:
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The study population consist of participants with type 1 diabetes (study 1) and participants with obesity and/or type 2 diabetes (study 1 and 2). Participants will be included at the Dept. of Endocrinology and Steno Diabetes Center Aarhus, Aarhus University Hospital, Denmark. Healthy control participants will be recruited by advertising in local media and at dedicated participant recruitment homepages.
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| Name | Affiliation | Role |
|---|---|---|
| Anders Stouge, MD, PhD-student | Aarhus University, Aarhus University Hospital, Denmark | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aarhus University Hospital, Denmark | Aarhus | Aarhus | 8000 | Denmark |
All IPD data that underlies results in a publication
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D009765 | Obesity |
| D015431 | Weight Loss |
| D055948 | Sarcopenia |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D050110 | Bariatric Surgery |
| ID | Term |
|---|---|
| D049088 | Bariatrics |
| D000073319 | Obesity Management |
| D013812 | Therapeutics |
| D013514 | Surgical Procedures, Operative |
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| Bariatric surgery | Procedure | Participants are examined prior to and 1 year following bariatric surgery in the Central Region, Denmark |
|
| Change from baseline to follow-up at an average of 6 months for study 1 and 12 months for study 3 |
| 31P MRS: Changes of skeletal muscle bioenergetics and metabolic economy in relation to weight-loss or glycemic improvement | Assessed by phosphorus magnetic resonance spectroscopy (31P MRS) performed during an isotonic fatiguing exercise in a 3T MR-scanner | Change from baseline to follow-up at an average of 6 months for study 1 and 12 months for study 3 |
| ENG assessment of neuropathic changes | ENG is assessed in the Sural, Tibial and Peroneal nerve | Change from baseline to follow-up at an average of 6 months for study 1 and 12 months for study 3 |
| Correlation analyses of primary measures with metabolic parameters including insulin resistance, HbA1c, metabolic economy, bioenergetics, and low-grade systemic inflammation (hs-CRP) | Change from baseline to follow-up at an average of 6 months for study 1 and 12 months for study 3 |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001836 | Body Weight Changes |
| D009133 | Muscular Atrophy |
| D020879 | Neuromuscular Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D001284 | Atrophy |
| D020763 | Pathological Conditions, Anatomical |