Diabetes MellitusNCT05685927
Investigating Muscle Failure in Diabetic Myopathy
An observational study of Diabetes Mellitus and Obesity, run by University of Aarhus at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus, Obesity, Chronic Hyperglycaemia
- What is being tested?
- 6-months of medically assisted glycemic improvement and Bariatric surgery
- Type of treatment
- Surgery or procedure
- How many people
- 108 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Nov 2022to 30 Dec 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: The study population consist of participants with type 1 diabetes (study 1) and participants with obesity and/or type 2 diabetes (study 1 and 2). Participants will be included at the Dept. of Endocrinology and Steno Diabetes Center Aarhus, Aarhus University Hospital, Denmark. Healthy control participants will be recruited by advertising in local media and at dedicated participant recruitment homepages.
Who may be able to join
- 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:
Show all 13Show fewer
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Understanding Muscular Deficits of 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:
Read more
- Is chronic hyperglycemia in type 1 and 2 diabetes associated with functional and structural deficits of skeletal muscles unrelated to the presence of neuropathy?
- Is obesity associated with functional and structural impairments of skeletal muscles unrelated to the presence of type 2 diabetes ?
- 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
- Being tested
- 6-months of medically assisted glycemic improvement, Bariatric surgery
- Medical subject headings
- Diabetes Mellitus, Obesity, Weight Loss, Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
6-months of medically assisted glycemic improvementDrug
Administrated by the clinic at Steno Diabetes Center, Aarhus, Denmark
Bariatric surgeryProcedure or surgery
Participants are examined prior to and 1 year following bariatric surgery in the Central Region, Denmark
| Study group | Role | What they receive |
|---|---|---|
| Non-obese participants with dysregulated type 1 diabetes | Not described Receives: Drug: 6-months of medically assisted glycemic improvement | |
| Non-obese participants with dysregulated type 2 diabetes | Not described Receives: Drug: 6-months of medically assisted glycemic improvement | |
| Obese participants with type 2 diabetes | Not described Receives: Procedure: Bariatric surgery | |
| Obese participants without type 2 diabetes | Not described Receives: Procedure: Bariatric surgery | |
| Healthy control participants | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Baseline: Evaluating the presence of sarcopenia in relation to the presence of hyperglycemia and/or obesity
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.
Measured: 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
Assessed by isokinetic knee-extension and dorsal flexion on a Biodex Dynamometer at increasing angular-velocities
Measured: 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
Assessed by a fatiguing isotonic protocol for knee-extension and dorsal flexion on a Biodex Dynamometer including twitch-parameters of knee-extensors
Measured: 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
Measured: 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
Measured: 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
Measured: Change from baseline to follow-up at an average of 6 months for study 1 and 12 months for study 3
Secondary outcomes (4)
31P MRS: Skeletal muscle bioenergetics and metabolic economy
Assessed by phosphorus magnetic resonance spectroscopy (31P MRS) performed during an isotonic fatiguing exercise in a 3T MR-scanner
Measured: Bioenergetics and metabolic economy in participants with diabetes and hyperglycemia (study 1) or obesity (study 2) as compared to healthy control participants at baseline
31P MRS: Changes of skeletal muscle bioenergetics and metabolic economy in relation to weight-loss or glycemic improvement
Assessed by phosphorus magnetic resonance spectroscopy (31P MRS) performed during an isotonic fatiguing exercise in a 3T MR-scanner
Measured: Change from baseline to follow-up at an average of 6 months for study 1 and 12 months for study 3
ENG assessment of neuropathic changes
ENG is assessed in the Sural, Tibial and Peroneal nerve
Measured: Change from baseline to follow-up at an average of 6 months for study 1 and 12 months for study 3
Correlation analyses of primary measures with metabolic parameters including insulin resistance, HbA1c, metabolic economy, bioenergetics, and low-grade systemic inflammation (hs-CRP)
Measured: Change from baseline to follow-up at an average of 6 months for study 1 and 12 months for study 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2023
- Study start1 Nov 2022
- Primary completion30 Sep 2025 (estimated)
- Study completion30 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by University of AarhusThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 108 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anders Stouge, MD, PhD-student, Principal investigator, Aarhus University, Aarhus University Hospital, Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05685927
- Sponsor's protocol ID
- DM2021AS
- Status last verified
- Feb 2025
- First submitted
- 3 Jan 2023
- Last updated
- 3 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All IPD data that underlies results in a publication
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Understanding Muscular Deficits of Diabetic Myopathy
- ClinicalTrials.gov ID
- NCT05685927
- Acronym / sponsor ID
- DM2021AS
- Conditions
- Diabetes Mellitus, Obesity, Chronic Hyperglycaemia, Weight Loss, Diabetic Myopathy, Sarcopenia
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 108 participants (estimated)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Study start
- 1 Nov 2022 (actual)
- Primary completion
- 30 Sep 2025 (estimated)
- Study completion
- 30 Dec 2025 (estimated)
- First posted
- 17 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Is chronic hyperglycemia in type 1 and 2 diabetes associated with functional and structural deficits of skeletal muscles unrelated to the presence of neuropathy?
- Is obesity associated with functional and structural impairments of skeletal muscles unrelated to the presence of type 2 diabetes ?
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Non-obese participants with dysregulated type 1 diabetes | – | Drug: 6-months of medically assisted glycemic improvement |
| Non-obese participants with dysregulated type 2 diabetes | – | Drug: 6-months of medically assisted glycemic improvement |
| Obese participants with type 2 diabetes | – | Procedure: Bariatric surgery |
| Obese participants without type 2 diabetes | – | Procedure: Bariatric surgery |
| Healthy control participants | – | – |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- The study population consist of participants with type 1 diabetes (study 1) and participants with obesity and/or type 2 diabetes (study 1 and 2). Participants will be included at the Dept. of Endocrinology and Steno Diabetes Center Aarhus, Aarhus University Hospital, Denmark. Healthy control participants will be recruited by advertising in local media and at dedicated participant recruitment homepages.
Key inclusion criteria (13 listed)
- 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
- Age: 25-60 years
Key exclusion criteria (7 listed)
- 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
- The presence of diabetes or pre-diabetes (HbA1c ≥42 mmol/mol)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 6-months of medically assisted glycemic improvementAdministrated by the clinic at Steno Diabetes Center, Aarhus, Denmark | Drug | Non-obese participants with dysregulated type 1 diabetes, Non-obese participants with dysregulated type 2 diabetes |
| Bariatric surgeryParticipants are examined prior to and 1 year following bariatric surgery in the Central Region, Denmark | Procedure or surgery | Obese participants with type 2 diabetes, Obese participants without type 2 diabetes |
Primary outcome
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.
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
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
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
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
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
4 secondary outcomes
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
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
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
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2025.
- Individual participant dataSharing planned: Yes. All IPD data that underlies results in a publication
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anders Stouge, MD, PhD-student principal investigator
Aarhus University, Aarhus University Hospital, Denmark
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes Mellitus and Obesity, run by University of Aarhus at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 3 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2025.