Investigating Muscle Failure in Diabetic Myopathy

Last updated: February 26, 2025
Sponsor: University of Aarhus
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Weight Loss

Obesity

Diabetes And Hypertension

Treatment

6-months of medically assisted glycemic improvement

Bariatric surgery

Clinical Study ID

NCT05685927
DM2021AS
  • Ages 18-60
  • All Genders
  • Accepts Healthy Volunteers

Study 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:

  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.

Eligibility Criteria

Inclusion

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 toenrollment

  • 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

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 rheumatologicaldisease which may affect muscle function, as well as any other disease that mayeffect ones ability to perform physical activity.

  • Any Magnetic Resonance contraindications

  • Any condition that by the principal investigator is expected to affect theparticipants ability to execute the study elements

Specifically for healthy control participants:

  • The presence of diabetes or pre-diabetes (HbA1c ≥42 mmol/mol)

Study Design

Total Participants: 108
Treatment Group(s): 2
Primary Treatment: 6-months of medically assisted glycemic improvement
Phase:
Study Start date:
November 01, 2022
Estimated Completion Date:
December 30, 2025

Connect with a study center

  • Aarhus University Hospital, Denmark

    Aarhus, 8000
    Denmark

    Site Not Available

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