Pilot - Resistance Exercise for Inpatient Treatment in T2D (P-REFIT-T2D)

January 19, 2026 updated by: Julie Abildgaard, Rigshospitalet, Denmark

Exercise Training During Hospitalization in Patients With Type 2 Diabetes - A Phase 1 Trial

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Patients will be invited to participate, preferably within the first 24 hours of admission, and randomized to either resistance-based bodyweight exercise or a control group. In total, 24 patients will be recruited, and distributed between the groups stratified for biological sex. At baseline, participants will have their medical history, social anamnesis, height, and weight assessed. At baseline a continuous glucose monitor will and accelerometer will be applied, to be worn until discharge and end of the intervention, respectively. Furthermore at baseline a multitude of questionnaires will be performed: International Physical Activity Questionnaire (IPAQ), Strength, Assistance in walking, Rise from a chair, Climb stairs, and Falls (SARC-F), Brief Illness Perception Questionnaire (BIPQ), 5-level EQ-5D version (EQ-5D-5L), WHO-5 Well-Being Index (WHO-5).

Intervention session A body-weight based resistance exercise program will be performed based on a booklet "Syg men sund og aktiv" Sick but healthy and active for 30 minutes per day. Described in more detail below.

Control session The control group will be placed in a seated position for 30 minutes corresponding to the time the intervention group is active.

Assessments before and after intervention/control sessions Before the sessions the EQ-5D-5L, the WHO-5 modified to a daily version, and an acute assessment of malaise, tiredness, nausea, dizziness, pain and breathlessness will be performed using numerical rating scales (NRS). After the session the NRS will be performed again.

Follow-up visit Two days after completion of the intervention, the participants will be invited for a follow-up visit at the Centre for Physical Activity Research, Rigshospitalet. This visit includes a qualitative interview, assessment of body composition, assessment of physical capabilities, ultrasound of the thigh, and blood samples. In case the patient is unable to attend the follow-up visit at the center, the daily operating manager will visit the patient at home. In this case, Ultrasound and muscle biopsy will not be performed. If the patient lives more than one hour away by car, the assessment will be performed online and will not include ultrasound, body composition and blood tests.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
4

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Denmark
    • Capitol Region of Denmark
      • Copenhagen, Capitol Region of Denmark, Denmark, 2100
        • Copenhagen University Hospital
      • Copenhagen, Capitol Region of Denmark, Denmark, 2650
        • Departement of Infectious Diseases - Hvidovre Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Exercise
The exercise intervention is a four-week intervention and will consist of body weight strength training. All training sessions during hospitalization will be supervised and will be performed individually for 30 min/day. If the patient is discharged within the four-week training period, the training will continue from home and will be online-based with a live video connection to an instructor. The training program will be the same. The intervention group will ideally exercise post-prandially (within 60 min following the meal) following either breakfast or lunch. Exercise intensity will be monitored throughout the training (with a heart rate monitor) and patients will estimate the rigorousness of the training using the rate of perceived exertion (RPE)-scale. If possible, the goal is for the patients to reach a minimum of 5, corresponding to moderate intensity, but preferably 7+ on the 0-10 RPE scale in each set. The aim is to complete the training sessions five out of seven days/week.
Behavioral: Exercise
A body weight based resistance training.
No Intervention: Control
The Control group will be placed in a chair for 30 minutes, within 60 minutes following either breakfast or lunch daily during admission, depending on other workflows in the ward. This corresponds to the time spent on exercise by the intervention group. The control group will also be in daily contact with the instructor following discharge and will be asked the same daily questions and will be seated in a chair for 30 minutes as during hospitalization.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Feasibility of exercise in hospitalized patients with type 2 diabetes
Time Frame: Baseline to follow-up visit (4 weeks).

• Recruitment: Include 24 patients in five months. Failure to achieve this goal will indicate challenges in the recruitment process. The recruitment will be continuously evaluated.

o Failure to recruit 5 participants within the 1st month of recruitment will lead to patients with prediabetes (HbA1c ≥ 42 mmol/mol) being eligible for inclusion. This criterion will be assessed monthly and if the projected recruitment of 4-5 patients/month is not met, the inclusion criteria will be expanded to include prediabetes. If so, an amendment will be submitted to change the title of the project to include prediabetes. An intermediate state of diabetes also has a higher frequency of critical outcomes during hospitalization, and is inversely related to skeletal muscle mass.
Baseline to follow-up visit (4 weeks).
Glycemic variability
Time Frame: Baseline until discharge, with a maximum of 4 weeks post-inclusion.

Coefficient of variance (%CV) during hospitalization evaluated using a continuous glucose monitor.

Defined as the oscillations in blood glucose occurring throughout the day. High glycemic variability is associated with an increased risk of cardiovascular events, mortality, and impaired quality of life. Glycemic variability adds considerable nuance to blood glucose control and allows for short-term assessments compared to glycated hemoglobin. If the participant is not discharged after 4 weeks the data collection will stop.
Baseline until discharge, with a maximum of 4 weeks post-inclusion.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Short physical performance battery
Time Frame: Baseline to follow-up visit (4 weeks).
The Short Physical performance battery (SPPB) will be assessed at baseline, discharge and 30-day follow-up. The SPPB consists of a combined score of a balance test (with the feet together, in a semitandem and tandem position), a walking test measuring the average speed over a three-meter distance, and a chair raise test that evaluates the time it takes for the participant to stand up and sit down five times.
Baseline to follow-up visit (4 weeks).
Sit-down stand-up test
Time Frame: Baseline to follow-up visit (4 weeks).
A sit down stand-up test will be performed at baseline, discharge and 30-day follow-up to assess the number of times the participant can stand up and sit down from a chair within 60 seconds.
Baseline to follow-up visit (4 weeks).
Grip strength
Time Frame: Baseline to follow-up visit (4 weeks).
Grip strength will be assessed at baseline, discharge and 30-day follow-up. Measurements will be taken three times per hand, with the participant in a seated position. The upper arm will be parallel to the torso, the elbow flexed at 90 degrees, and the wrist in a neutral position.
Baseline to follow-up visit (4 weeks).
Duration of hospitalization
Time Frame: Baseline until discharge, with a maximum of 1 year post intervention.
Number of days in hospital, from baseline until a maximum of 1 year post intervention.
Baseline until discharge, with a maximum of 1 year post intervention.
Insulin use during hospitalization
Time Frame: Baseline until discharge, with a maximum of 4 weeks post-inclusion.
Number of daily units during hospitalization, from baseline until a maximum of 4 weeks.
Baseline until discharge, with a maximum of 4 weeks post-inclusion.
Mean glucose levels
Time Frame: Baseline until discharge, with a maximum of 4 weeks post-inclusion.

Mean glucose levels during hospitalization assessed using a continuous glucose monitor.

If the participant is not discharged after 4 weeks the data collection will stop.
Baseline until discharge, with a maximum of 4 weeks post-inclusion.
Time in hyperglycemia
Time Frame: Baseline until discharge, with a maximum of 4 weeks post-inclusion.

Time in hyperglycemia (blood glucose > 10 mmol/l) during hospitalization assessed using a continuous glucose monitor.

If the participant is not discharged after 4 weeks the data collection will stop.
Baseline until discharge, with a maximum of 4 weeks post-inclusion.
Time in hypoglycemia
Time Frame: Baseline until discharge, with a maximum of 4 weeks post-inclusion.

Time in hypoglycemia (blood glucose < 4 mmol/l) during hospitalization assessed using a continuous glucose monitor.

If the participant is not discharged after 4 weeks the data collection will stop.
Baseline until discharge, with a maximum of 4 weeks post-inclusion.
Time in normal glucose range
Time Frame: Baseline until discharge, with a maximum of 4 weeks post-inclusion.

Time in normal range (6-10 mmol/l in accordance with Danish guidelines), during hospitalization assessed using a continuous glucose monitor.

If the participant is not discharged after 4 weeks the data collection will stop.
Baseline until discharge, with a maximum of 4 weeks post-inclusion.
Mean amplitude of glucose excursions
Time Frame: Baseline until discharge, with a maximum of 4 weeks post-inclusion.
Mean amplitude of glucose excursions from peaks to nadirs that are > 1 SD of mean glucose, assessed during hospitalization assessed using a continuous glucose monitor. If the participant is not discharged after 4 weeks the data collection will stop.
Baseline until discharge, with a maximum of 4 weeks post-inclusion.
Cognitive function
Time Frame: Baseline to follow-up visit (4 weeks).
Assessed using the Mini-mental state examination at baseline, discharge and follow-up visit. If the participant is not discharged after 4 weeks the follow-up will be examined at the hospital.
Baseline to follow-up visit (4 weeks).
Strength, Assistance in walking, Rise from a chair, Climb stairs, and Falls (SARC-F) questionnaire.
Time Frame: Baseline to follow-up visit (4 weeks).
Assessed at baseline, discharge and follow-up visit using the questionnaire Strength, Assistance in walking, Rise from a chair, Climb stairs, and Falls (SARC-F).
Baseline to follow-up visit (4 weeks).
Perceived health - Health-related Quality of Life questionnaire (Euroqol EQ-5D-5L)
Time Frame: Baseline to follow-up visit (4 weeks).
Assessed at baseline, discharge and follow-up visit using the questionnaire Health-related Quality of Life questionnaire (Euroqol EQ-5D-5L).
Baseline to follow-up visit (4 weeks).
Perceived health - Brief Illness Perception Questionnaire (BIPQ)
Time Frame: Baseline to follow-up visit (4 weeks).
Assessed at baseline, discharge and follow-up visit using the questionnaire Brief Illness Perception Questionnaire (BIPQ).
Baseline to follow-up visit (4 weeks).
Dual Energy X-Ray Absorptiometry - Appendicular lean mass
Time Frame: Follow-up visit (4 weeks).
Difference between exercise and control group in appendicular lean mass assessed at the 4-week follow-up using dual energy x-ray absorptiometry.
Follow-up visit (4 weeks).
Dual Energy X-Ray Absorptiometry - Percentage of body fat
Time Frame: Follow-up visit (4 weeks).
Difference between exercise and control group in percentage of body fat assessed at the 4-week follow-up using dual energy x-ray absorptiometry.
Follow-up visit (4 weeks).
Dual Energy X-Ray Absorptiometry - Android fat
Time Frame: Follow-up visit (4 weeks).
Difference between exercise and control group in android fat assessed at the 4-week follow-up using dual energy x-ray absorptiometry.
Follow-up visit (4 weeks).
Dual Energy X-Ray Absorptiometry- Gynoid fat
Time Frame: Follow-up visit (4 weeks).
Difference between exercise and control group in gynoid fat assessed at the 4-week follow-up using dual energy x-ray absorptiometry.
Follow-up visit (4 weeks).
Rectus femoris cross-sectional area
Time Frame: Baseline to follow-up visit (4 weeks).
Change in cross-sectional area assessed at baseline, discharge and 4-week follow-up using an ultrasound of rectus femoris in the dominant leg. If the participant is not discharged after 4 weeks, only baseline and follow-up will be assessed. It will be measured at the distal third and midpoint between the anterior superior iliac spine and the proximal point of the patella.
Baseline to follow-up visit (4 weeks).
Rectus femoris echo intensity
Time Frame: Baseline to follow-up visit (4 weeks).
Change in echo intensity of rectus femoris assessed at baseline, discharge and 4-week follow-up using skeletal muscle ultrasound in the dominant leg. If the participant is not discharged after 4 weeks, only baseline and follow-up will be assessed. It will be measured at the distal third and midpoint between the anterior superior iliac spine and the proximal point of the patella.
Baseline to follow-up visit (4 weeks).
Rectus femoris echo variation
Time Frame: Baseline to follow-up visit (4 weeks).
Change in echo variation of rectus femoris assessed at baseline, discharge and 4-week follow-up using skeletal muscle ultrasound in the dominant leg. If the participant is not discharged after 4 weeks, only baseline and follow-up will be assessed. It will be measured at the distal third and midpoint between the anterior superior iliac spine and the proximal point of the patella.
Baseline to follow-up visit (4 weeks).
Rectus femoris pennation angle
Time Frame: Baseline to follow-up visit (4 weeks).
Change in pennation angle of rectus femoris assessed at baseline, discharge and 4-week follow-up using skeletal muscle ultrasound in the dominant leg. If the participant is not discharged after 4 weeks, only baseline and follow-up will be assessed. It will be measured at the distal third and midpoint between the anterior superior iliac spine and the proximal point of the patella.
Baseline to follow-up visit (4 weeks).
Thickness of the anterior thigh muscles
Time Frame: Baseline to follow-up visit (4 weeks).
Change in anterior thigh muscle thickness assessed at baseline, discharge and 4-week follow-up, measured from the mid-anterior point rectus femoris to the mid posterior point of vastus intermedius of the femoral quadriceps in the dominant leg. If the participant is not discharged after 4 weeks, only baseline and follow-up will be assessed. It will be measured at the distal third and midpoint between the anterior superior iliac spine and the proximal point of the patella.
Baseline to follow-up visit (4 weeks).
Thickness of rectus femoris
Time Frame: Baseline to follow-up visit (4 weeks).
Change in rectus femoris muscle thickness assessed at baseline, discharge and 4-week follow-up, measured from the mid-anterior point rectus femoris to the mid posterior point in the dominant leg. If the participant is not discharged after 4 weeks, only baseline and follow-up will be assessed. It will be measured at the distal third and midpoint between the anterior superior iliac spine and the proximal point of the patella.
Baseline to follow-up visit (4 weeks).
Bioelectrical Impedance - Appendicular lean body mass
Time Frame: Baseline to follow-up visit (4 weeks).
Change in estimated appendicular lean body mass using bioelectrical impedance assessed at baseline, discharge and 4-week follow-up. If the participant is not discharged after 4 weeks, only baseline and follow-up will be assessed.
Baseline to follow-up visit (4 weeks).
Bioelectrical Impedance - Total lean body mass
Time Frame: Baseline to follow-up visit (4 weeks).
Change in estimated total lean body mass using bioelectrical impedance assessed at baseline, discharge and 4-week follow-up. If the participant is not discharged after 4 weeks, only baseline and follow-up will be assessed.
Baseline to follow-up visit (4 weeks).
Bioelectrical Impedance - Percentage of body fat
Time Frame: Baseline to follow-up visit (4 weeks).
Change in estimated percentage of body fat using bioelectrical impedance assessed at baseline, discharge and 4-week follow-up. If the participant is not discharged after 4 weeks, only baseline and follow-up will be assessed.
Baseline to follow-up visit (4 weeks).
Readmission rates.
Time Frame: Baseline until 1 year follow-up.
Time-to-event, number of events and number of days and reason for event will be assessed. The event will be assessed at 30 days post-discharge, 90 days post-discharge, and 1 year post intervention.
Baseline until 1 year follow-up.
Sick leave rates.
Time Frame: Baseline until 1 year follow-up.
Time-to-event, number of events and number of days and reason for event will be assessed. The event will be assessed at 30 days post-discharge, 90 days post-discharge, and 1 year post intervention
Baseline until 1 year follow-up.
All cause mortality
Time Frame: Baseline until 1 year follow-up.
Time-to-event, number of events and number of days and reason for event will be assessed. The event will be assessed during hospitalization, 30 days post-discharge, 90 days post-discharge, and 1 year post intervention.
Baseline until 1 year follow-up.
Use of antidiabetic medication 1-year post inclusion
Time Frame: Baseline until 1 year follow-up.
The use of which types of antidiabetic medication will be assessed at baseline, discharge, and 1-year follow up.
Baseline until 1 year follow-up.
Circulatory factors in plasma - Interferon-γ
Time Frame: Baseline to follow-up visit (4 weeks).
Change in plasma Interferon-γ assessed using the Meso Scale Discovery's V-PLEX Proinflammatory Panel 1 Human Kit. These samples will be conducted at baseline, discharge, and follow-up visit. If the participant is not discharged within 4 weeks, samples will only be collected at baseline and follow-up.
Baseline to follow-up visit (4 weeks).
Circulatory factors in plasma - Interleukin-1β
Time Frame: Baseline to follow-up visit (4 weeks).
Change in plasma interleukin-1β assessed using the Meso Scale Discovery's V-PLEX Proinflammatory Panel 1 Human Kit. These samples will be conducted at baseline, discharge, and follow-up visit. If the participant is not discharged within 4 weeks, samples will only be collected at baseline and follow-up.
Baseline to follow-up visit (4 weeks).
Circulatory factors in plasma - Interleukin-2
Time Frame: Baseline to follow-up visit (4 weeks).
Change in plasma interleukin-2 assessed using the Meso Scale Discovery's V-PLEX Proinflammatory Panel 1 Human Kit. These samples will be conducted at baseline, discharge, and follow-up visit. If the participant is not discharged within 4 weeks, samples will only be collected at baseline and follow-up.
Baseline to follow-up visit (4 weeks).
Circulatory factors in plasma - Interleukin-4
Time Frame: Baseline to follow-up visit (4 weeks).
Change in plasma interleukin-4 assessed using the Meso Scale Discovery's V-PLEX Proinflammatory Panel 1 Human Kit. These samples will be conducted at baseline, discharge, and follow-up visit. If the participant is not discharged within 4 weeks, samples will only be collected at baseline and follow-up.
Baseline to follow-up visit (4 weeks).
Circulatory factors in plasma - Interleukin-6
Time Frame: Baseline to follow-up visit (4 weeks).
Change in plasma interleukin-6 assessed using the Meso Scale Discovery's V-PLEX Proinflammatory Panel 1 Human Kit. These samples will be conducted at baseline, discharge, and follow-up visit. If the participant is not discharged within 4 weeks, samples will only be collected at baseline and follow-up.
Baseline to follow-up visit (4 weeks).
Circulatory factors in plasma - Interleukin-8
Time Frame: Baseline to follow-up visit (4 weeks).
Change in plasma interleukin-8 assessed using the Meso Scale Discovery's V-PLEX Proinflammatory Panel 1 Human Kit. These samples will be conducted at baseline, discharge, and follow-up visit. If the participant is not discharged within 4 weeks, samples will only be collected at baseline and follow-up.
Baseline to follow-up visit (4 weeks).
Circulatory factors in plasma - Interleukin-10
Time Frame: Baseline to follow-up visit (4 weeks).
Change in plasma interleukin-8 assessed using the Meso Scale Discovery's V-PLEX Proinflammatory Panel 1 Human Kit. These samples will be conducted at baseline, discharge, and follow-up visit. If the participant is not discharged within 4 weeks, samples will only be collected at baseline and follow-up.
Baseline to follow-up visit (4 weeks).
Circulatory factors in plasma - Interleukin-12p70
Time Frame: Baseline to follow-up visit (4 weeks).
Change in plasma interleukin-12p70 assessed using the Meso Scale Discovery's V-PLEX Proinflammatory Panel 1 Human Kit. These samples will be conducted at baseline, discharge, and follow-up visit. If the participant is not discharged within 4 weeks, samples will only be collected at baseline and follow-up.
Baseline to follow-up visit (4 weeks).
Circulatory factors in plasma - Interleukin-13
Time Frame: Baseline to follow-up visit (4 weeks).
Change in plasma interleukin-13 assessed using the Meso Scale Discovery's V-PLEX Proinflammatory Panel 1 Human Kit. These samples will be conducted at baseline, discharge, and follow-up visit. If the participant is not discharged within 4 weeks, samples will only be collected at baseline and follow-up.
Baseline to follow-up visit (4 weeks).
Circulatory factors in plasma - Tumor Necrosis Factor-α
Time Frame: Baseline to follow-up visit (4 weeks).
Change in plasma tumor necrosis factor-α assessed using the Meso Scale Discovery's V-PLEX Proinflammatory Panel 1 Human Kit. These samples will be conducted at baseline, discharge, and follow-up visit. If the participant is not discharged within 4 weeks, samples will only be collected at baseline and follow-up.
Baseline to follow-up visit (4 weeks).
Circulatory factors in plasma - Myostatin
Time Frame: Baseline to follow-up visit (4 weeks).
Change in plasma myostatin assessed using a Meso Scale custom plate. These samples will be conducted at baseline, discharge, and follow-up visit. If the participant is not discharged within 4 weeks, samples will only be collected at baseline and follow-up.
Baseline to follow-up visit (4 weeks).
Circulatory factors in plasma - Follistatin
Time Frame: Baseline to follow-up visit (4 weeks).
Change in plasma follistatin assessed using a Meso Scale custom plate. These samples will be conducted at baseline, discharge, and follow-up visit. If the participant is not discharged within 4 weeks, samples will only be collected at baseline and follow-up.
Baseline to follow-up visit (4 weeks).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Rigshospitalet, Denmark

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
TrygFonden, Denmark

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 12, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 19, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 20, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 28, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 7, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 9, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 21, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 19, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • H-24002354
  • PREFIT-T2D (Other Identifier: Centre for Physical Activity Research)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

If the data can be fully anonymized the researchers will consider to share the data

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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