NCT05685927Active, not recruiting
Investigating Muscle Failure in Diabetic Myopathy
Understanding Muscular Deficits of Diabetic Myopathy
Source: ClinicalTrials.gov · Last updated 3 Mar 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Observational
- Enrollment
- 108 (estimated)
- First submitted
- 3 Jan 2023
- Start date
- 1 Nov 2022
- Primary completion date
- 30 Sept 2025
- Lead sponsor
- University of Aarhus
- Diseases
- Obesity
- NCT number
- NCT05685927
What you commit to
- Study type: Observational
- Planned participants: 108
- From 1 Nov 2022 to the primary completion date, 30 Sept 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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 condition that by the principal investigator is expected to affect the participants ability to execute the study elements
- Specifically for healthy control participants:
Lab values
- The presence of diabetes or pre-diabetes (HbA1c ≥42 mmol/mol)
Other
- Study 1, 2, 3 and healthy controls:
- Diabetic neuropathy with expected motor deficits
- Any Magnetic Resonance contraindications
Who the study is looking for
- 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
Age in the registry: 18 years to 60 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Aarhus University Hospital, Denmark Coordinator of this site? Confirm its status | Aarhus | Denmark | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.