Pilot - Resistance Exercise for Inpatient Treatment in T2D
NCT Number: NCT06547541
Acronym: P-REFIT-T2D
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Diabetes Mellitus, Type 2
Interventions: BEHAVIORAL: Exercise
Sponsor: Rigshospitalet, Denmark
Collaborators: TrygFonden, Denmark
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 24
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-08-12
Completion Date: 2026-01
Locations: Copenhagen University Hospital, Copenhagen, Capitol Region Of Denmark, 2100, Denmark

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 will be recruited from the Department of Infectious Diseases at Rigshospitalet 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.

Primary Outcome Measures: Feasibility of exercise in hospitalized patients with type 2 diabetes, • 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, 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: Short physical performance battery, 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, 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, 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, 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, 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, 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 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 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 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, 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, 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., 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), 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), 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, 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, 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, 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, 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, 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, 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, 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, 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, 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, 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, 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, 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, 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-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-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-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, 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, 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, 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, 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, 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, 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, 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, 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, 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, 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, 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, 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, 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).