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NCT Number: NCT05685927

Investigating Muscle Failure in Diabetic Myopathy

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Diabetes Mellitus Atrophy Body Weight Body Weight Changes Chronic Hyperglycaemia Diabetic Myopathy Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Muscular Atrophy Nervous System Diseases Neurologic Manifestations Neuromuscular Manifestations Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Sarcopenia Signs and Symptoms Weight Loss

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Aarhus University Hospital, Denmark

Aarhus, 8000, Denmark

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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

  1. Baseline: Evaluating the presence of sarcopenia in relation to the presence of hyperglycemia and/or obesity

    Time frame: The prevalence of sarcopenia in participants with diabetes and hyperglycemia (study 1) or obesity (study 2) as compared to healthy control participants at baseline

    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.

  2. Baseline: Skeletal muscle Force-velocity assessment in relation to the presence of hyperglycemia and/or obesity

    Time frame: The force-velocity relationship in participants with diabetes and hyperglycemia (study 1) or obesity (study 2) as compared to healthy control participants at baseline

    Assessed by isokinetic knee-extension and dorsal flexion on a Biodex Dynamometer at increasing angular-velocities

  3. Baseline: Assessment of skeletal muscle fatigue in relation to the presence of hyperglycemia and/or obesity

    Time frame: Fatigue in participants with diabetes and hyperglycemia (study 1) or obesity (study 2) as compared to healthy control participants at baseline

    Assessed by a fatiguing isotonic protocol for knee-extension and dorsal flexion on a Biodex Dynamometer including twitch-parameters of knee-extensors

  4. Changes in skeletal muscle force-velocity relationship with weight-loss or glycemic improvement

    Time frame: Change from baseline to follow-up at an average of 6 months for study 1 and 12 months for study 3

  5. Changes in skeletal muscle fatigue in relation to weight-loss or glycemic improvement

    Time frame: Change from baseline to follow-up at an average of 6 months for study 1 and 12 months for study 3

  6. Changes in parameters defining sarcopenia in relation to weight-loss or glycemic improvement

    Time frame: Change from baseline to follow-up at an average of 6 months for study 1 and 12 months for study 3

Secondary outcomes

  1. 31P MRS: Skeletal muscle bioenergetics and metabolic economy

    Time frame: Bioenergetics and metabolic economy in participants with diabetes and hyperglycemia (study 1) or obesity (study 2) as compared to healthy control participants at baseline

    Assessed by phosphorus magnetic resonance spectroscopy (31P MRS) performed during an isotonic fatiguing exercise in a 3T MR-scanner

  2. 31P MRS: Changes of skeletal muscle bioenergetics and metabolic economy in relation to weight-loss or glycemic improvement

    Time frame: Change from baseline to follow-up at an average of 6 months for study 1 and 12 months for study 3

    Assessed by phosphorus magnetic resonance spectroscopy (31P MRS) performed during an isotonic fatiguing exercise in a 3T MR-scanner

  3. ENG assessment of neuropathic changes

    Time frame: Change from baseline to follow-up at an average of 6 months for study 1 and 12 months for study 3

    ENG is assessed in the Sural, Tibial and Peroneal nerve

  4. Correlation analyses of primary measures with metabolic parameters including insulin resistance, HbA1c, metabolic economy, bioenergetics, and low-grade systemic inflammation (hs-CRP)

    Time frame: Change from baseline to follow-up at an average of 6 months for study 1 and 12 months for study 3

Other outcomes

  1. EMG assessment of myopathic changes

    Time frame: Change from baseline to follow-up at an average of 6 months for study 1 and 12 months for study 3

    Will be assessed in knee extensors and/or dorsal flexors on a subgroup of participants demonstrating significant fatigue during primary measures

Sponsors and collaborators

Lead sponsor

University of Aarhus

Other

Registry information

Official study title

Understanding Muscular Deficits of Diabetic Myopathy

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Jan 17, 2023
Registry last updated
Mar 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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