Investigating Muscle Failure in Diabetic Myopathy

NCT ID: NCT05685927

Last Updated: 2025-03-03

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 108 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-11-01
• Study Completion Date: 2025-12-30

Brief 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.

Conditions

Diabetes Mellitus; Obesity; Chronic Hyperglycaemia; Weight Loss; Diabetic Myopathy; Sarcopenia

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Non-obese participants with dysregulated type 1 diabetes

6-months of medically assisted glycemic improvement

Intervention Type: DRUG

Administrated by the clinic at Steno Diabetes Center, Aarhus, Denmark

Non-obese participants with dysregulated type 2 diabetes

6-months of medically assisted glycemic improvement

Intervention Type: DRUG

Administrated by the clinic at Steno Diabetes Center, Aarhus, Denmark

Obese participants with type 2 diabetes

Bariatric surgery

Intervention Type: PROCEDURE

Participants are examined prior to and 1 year following bariatric surgery in the Central Region, Denmark

Obese participants without type 2 diabetes

Bariatric surgery

Intervention Type: PROCEDURE

Participants are examined prior to and 1 year following bariatric surgery in the Central Region, Denmark

Healthy control participants

No interventions assigned to this group

Interventions

6-months of medically assisted glycemic improvement

Administrated by the clinic at Steno Diabetes Center, Aarhus, Denmark

Intervention Type: DRUG

Bariatric surgery

Participants are examined prior to and 1 year following bariatric surgery in the Central Region, Denmark

Intervention Type: PROCEDURE

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Aarhus

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Anders Stouge, MD, PhD-student

Role: PRINCIPAL_INVESTIGATOR

Aarhus University, Aarhus University Hospital, Denmark

Locations

Aarhus University Hospital, Denmark

Aarhus, Aarhus, Denmark

Countries

Denmark

Other Identifiers

DM2021AS

Identifier Type: -

Identifier Source: org_study_id