Clinical trial

Understanding Muscular Deficits of Diabetic Myopathy

Name
DM2021AS
Description
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.
Trial arms
Trial start
2022-11-01
Estimated PCD
2025-09-30
Trial end
2025-12-30
Status
Recruiting
Treatment
6-months of medically assisted glycemic improvement
Administrated by the clinic at Steno Diabetes Center, Aarhus, Denmark
Arms:
Non-obese participants with dysregulated type 1 diabetes, Non-obese participants with dysregulated type 2 diabetes
Bariatric surgery
Participants are examined prior to and 1 year following bariatric surgery in the Central Region, Denmark
Arms:
Obese participants with type 2 diabetes, Obese participants without type 2 diabetes
Size
108
Primary endpoint
Baseline: Evaluating the presence of sarcopenia in relation to the presence of hyperglycemia and/or obesity
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
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
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
Change from baseline to follow-up at an average of 6 months for study 1 and 12 months for study 3
Eligibility criteria
Inclusion Criteria: Study 1: * Age: 18-60 years * BMI: 18.5 - 27, minimum weight = 50kg * Chronic hyperglycemia: HbA1c of ≥ 70 mmol/mol with a duration of ≥ 2 months * 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 - 27, 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 * 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)
Protocol
{'studyType': 'OBSERVATIONAL', 'patientRegistry': False, 'designInfo': {'observationalModel': 'COHORT', 'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'count': 108, 'type': 'ESTIMATED'}}
Updated at
2023-12-04

1 organization

1 product

6 indications

Organization
Aarhus University
Indication
Obesity
Indication
Hyperglycemia
Indication
Sarcopenia