Pilot - Resistance Exercise for Inpatient Treatment in T2D (NCT06547541) | Clinical Trial Compass
TerminatedPhase 1
Pilot - Resistance Exercise for Inpatient Treatment in T2D
Stopped: Too low recruitment.
Denmark4 participantsStarted 2024-08-12
Plain-language summary
Type 2 Diabetes (T2D) is associated with prolonged hospitalization and an increased risk of readmission. Moreover, sedentary behavior and poor glycemic control may contribute to disease severity and mortality. The inactivity during hospitalization is particularly concerning in T2D patients, due to the negative effect on glucose metabolism and secondary loss of skeletal muscle mass, which can further disrupt glucose regulation. However, there are no exercise guidelines for hospitalized T2D patients. To address this gap, a feasibility study will be conducted examining the effectiveness of incorporating resistance training into hospital care for T2D patients. For the feasibility study, 24 patients with T2D or prediabetes will be recruited from the Department of Infectious Diseases at Rigshospitalet and Hvidovre Hospital and randomized to 4 weeks of resistance training for 30 minutes per day or standard treatment. If the participants are discharged they will be offered online-training sessions. During the hospitalization a continuous glucose monitor will be applied and an accelerometer during the full intervention. At baseline, discharge and at follow-up, extensive testing will be performed.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* T2D or prediabetes defined as at least one of the following
* ICD-10 diagnosis of T2D (DE11.x)
* HbA1c \> 48 at time of admission
* Use of type 2 antidiabetic medicine (excluding SGLT2 inhibitors)
* HbA1c ≥ 42 within 3 months of admission (prediabetes) (from 18 of September, 2024)
* Hospitalized with an infection
* Expected residual hospitalization time of at least three days
* At least 18 years of age
* Able to perform exercises in the booklet "Syg men sun dog aktiv"
Exclusion Criteria:
* Admitted to the hospital more than 5 days ago
* Unable to give written consent to participate
* Terminal illness
* Unstable or new onset angina
* Ventricular arrhythmia
* Aortic stenosis
* Sternotomy in conjunction with the current hospitalization
* Blood pressure greater than 180/120 mmHg
* Kidney failure requiring dialysis
* Unable to follow the 3-stage command of the Mini-Mental State Examination
* Known allergy or contact dermatitis to tape, and CGMs
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Feasibility of exercise in hospitalized patients with type 2 diabetes
Timeframe: Baseline to follow-up visit (4 weeks).
2
Glycemic variability
Timeframe: Baseline until discharge, with a maximum of 4 weeks post-inclusion.