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Investigating Muscle Failure in Diabetic Myopathy

NCT05685927 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 108

Last updated 2025-03-03

No results posted yet for this 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.

Conditions

Interventions

DRUG

6-months of medically assisted glycemic improvement

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

PROCEDURE

Bariatric surgery

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

Sponsors & Collaborators

  • University of Aarhus

    lead OTHER

Principal Investigators

  • Anders Stouge, MD, PhD-student · Aarhus University, Aarhus University Hospital, Denmark

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-11-01
Primary Completion
2025-09-30
Completion
2025-12-30

Countries

  • Denmark

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05685927 on ClinicalTrials.gov