Rowing and Cycling Reduce Inflammation in Early-Stage Type 2 Diabetes
Effects of Different Modes of Rowing Combined With Cycling Exercise on Inflammatory Markers in Newly Diagnosed Type 2 Diabetes Patients
Tutkimuksen yleiskatsaus
Tila
Tila
Ehdot
Ehdot
Interventio / Hoito
Interventio / Hoito
Yksityiskohtainen kuvaus
Study Process
- Screening & enrolment - We recruit 128 adults (18-60 years) who have been diagnosed with type 2 diabetes within the last 12 months and have never taken diabetes medication.
- Baseline assessments - Before starting, all participants undergo blood tests (glucose, insulin, inflammatory markers), a continuous glucose monitor (CGM) is placed on their arm, and they wear an activity tracker for 7 days.
Randomization - Participants are randomly assigned to one of four groups (32 people each):
Control - usual care, no exercise
Cycling - 40 min of moderate-intensity cycling per day
Rowing (HIIT) - 24 min of high-intensity interval rowing per day
Combined - 20 min rowing + 20 min cycling (50 min total)
- Intervention - All exercise groups train once a day for 7 consecutive days at the research centre under supervision. Heart rate is monitored throughout.
- Continuous monitoring - The CGM records glucose levels every 15 minutes during the whole 7-day period. Activity trackers record physical activity outside the exercise sessions.
- Post-intervention assessments - On day 8, we repeat all blood tests, measure inflammatory markers again, and collect the CGM data.
9. Data analysis - We compare changes in blood sugar fluctuations and inflammation between the groups, and use statistical models to find which exercise regimen works best and for whom (e.g., younger vs. older patients).
The entire study takes about 9 days per participant (1 week of exercise + 2 days of testing).
Opintotyyppi
Opintotyyppi
Ilmoittautuminen (Arvioitu)
Ilmoittautuminen
Vaihe
Vaihe
- Ei sovellettavissa
Yhteystiedot ja paikat
Opiskeluyhteys
Opiskeluyhteys
- Nimi: Xuebai Chen
- Puhelinnumero: +8618760590880
- Sähköposti: Chenxuebai@126.com
Tutki yhteystietojen varmuuskopiointi
- Nimi: Yanxin Huang, Dr
- Puhelinnumero: +8615960503382
- Sähköposti: 727937141@qq.com
Opiskelupaikat
-
-
Fujian
-
Putian, Fujian, Kiina, 351100
- The Ethics Committee of Putian 95 Hospital
-
Ottaa yhteyttä:
- Xuebai Chen
- Puhelinnumero: +8618760590880
- Sähköposti: Chenxuebai@126.com
-
-
Osallistumiskriteerit
Kelpoisuusvaatimukset
Kelpoisuusvaatimukset
Opintokelpoiset iät
- Aikuinen
Hyväksyy terveitä vapaaehtoisia
Kuvaus
Inclusion Criteria:
- Age between 18-60 years, no gender limited;
- Meeting the WHO 1999 diagnostic criteria for T2DM, with a diagnosis time ≤12 months;
- Not having received hypoglycemic drug treatment (or only lifestyle intervention, and stopped medication ≥4 weeks before enrollment);
- Fasting blood glucose 7.0-13.9 mmol/L, glycated hemoglobin (HbA1c) 6.5%-10.0%;
- No regular exercise in the past 3 months (less than 2 times per week of moderate or higher intensity exercise, each <30 minutes);
- Voluntarily signing the informed consent form.
Exclusion Criteria:
- Type 1 diabetes, gestational diabetes, or other special types of diabetes;
- Severe cardiovascular or cerebrovascular diseases (NYHA heart function ≥III, recent myocardial infarction or unstable angina);
- Uncontrolled hypertension (resting systolic blood pressure ≥160 mmHg or diastolic blood pressure ≥100 mmHg);
- Severe liver or kidney dysfunction (ALT/AST ≥3 times the upper limit of normal, or eGFR<60 mL/min/1.73m²);
- Severe diabetic complications (such as proliferative retinopathy, severe neuropathy, diabetic foot);
- Pregnant or breastfeeding women;
- Mental illness or cognitive impairment that prevents compliance with the study;
- Stress events such as infection, trauma, or surgery in the past month;
- Participation in other interventional clinical studies;
- Musculoskeletal diseases of the upper or lower limbs that affect rowing machine or bicycle exercise.
Opintosuunnitelma
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
- Ensisijainen käyttötarkoitus: Hoito
- Jako: Satunnaistettu
- Inventiomalli: Rinnakkaistehtävä
- Naamiointi: Yksittäinen
Aseiden lukumäärä
Aseet ja interventiot
Osallistujaryhmä / ArmOsallistujaryhmä / Arm |
Interventio / HoitoInterventio / Hoito |
|---|---|
|
Active Comparator: Continuous Exercise - Cycling Group
Warm-up: 5 minutes of low-intensity cycling (50-60 W, approximately 40%-50% HRmax of continuous power cycling at) Main Training: 40 minutes 65%-75% HRmax (approximately 60%-70% VO₂peak), maintaining a cadence of 60-80 rpm Cool-down: 5 minutes of low-intensity cycling followed by stretching Total Duration: 50 minutes
|
Warm-up: 5 minutes of low-intensity cycling (50-60 W, approximately 40%-50% HRmax of continuous power cycling at) Main Training: 40 minutes 65%-75% HRmax (approximately 60%-70% VO₂peak), maintaining a cadence of 60-80 rpm Cool-down: 5 minutes of low-intensity cycling followed by stretching Total Duration: 50 minutes
|
|
Active Comparator: Rowing Ergometer High-Intensity Interval Training (RE-HIIT)
Warm-up: 5 minutes of low-intensity rowing at approximately 50% of maximum heart rate (HRmax). Main Training: 24 minutes of interval training consisting of 4 sets of high-intensity rowing for 4 minutes each (85%-90% HRmax), with 2 minutes of low-intensity active recovery (50%-60% HRmax) between each set. Maintain a stroke rate of 24-30 strokes per minute (SPM) for high-intensity intervals and 18-22 SPM for recovery intervals. Cool-down: 5 minutes of low-intensity rowing combined with stretching. Total Duration: 34 minutes |
Warm-up: 5 minutes of low-intensity rowing at approximately 50% of maximum heart rate (HRmax). Main Training: 24 minutes of interval training consisting of 4 sets of high-intensity rowing for 4 minutes each (85%-90% HRmax), with 2 minutes of low-intensity active recovery (50%-60% HRmax) between each set. Maintain a stroke rate of 24-30 strokes per minute (SPM) for high-intensity intervals and 18-22 SPM for recovery intervals. Cool-down: 5 minutes of low-intensity rowing combined with stretching. Total Duration: 34 minutes |
|
Kokeellinen: Combined Training Standard (CT-S)
Warm-up: 5 minutes of low-intensity activity (choose either cycling or rowing). Rowing Machine Segment: 20 minutes at an intensity of 65%-75% of maximum heart rate (HRmax) (approximately 60%-70% of VO₂peak), with a stroke rate of 22-26 strokes per minute (SPM). Bicycle Segment: 20 minutes at an intensity of 65%-75% of HRmax (approximately 60%-70% of VO₂peak), with a cadence of 60-80 revolutions per minute (rpm). Cool-down: 5 minutes of stretching. Total Duration: 50 minutes |
Warm-up: 5 minutes of low-intensity activity (choose either cycling or rowing). Rowing Machine Segment: 20 minutes at an intensity of 65%-75% of maximum heart rate (HRmax) (approximately 60%-70% of VO₂peak), with a stroke rate of 22-26 strokes per minute (SPM). Bicycle Segment: 20 minutes at an intensity of 65%-75% of HRmax (approximately 60%-70% of VO₂peak), with a cadence of 60-80 revolutions per minute (rpm). Cool-down: 5 minutes of stretching. Total Duration: 50 minutes |
|
Ei väliintuloa: Control Group (CG)
Maintain usual activity levels without engaging in any structured exercise training.
Daily activity levels are recorded using an accelerometer.
|
Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
|
inflammatory cytokines
Aikaikkuna: 1.4 weeks
|
IL-6 (Interleukin-6) - The first muscle factor induced by exercise, is the core molecule connecting exercise to systemic anti-inflammatory effects. IL-6 produced by skeletal muscles during exercise inhibits TNF-α and stimulates IL-1ra to exert anti-inflammatory effects. Different exercise patterns have varying regulations on IL-6, with both aerobic training and combined training significantly reducing IL-6 levels in T2DM patients. TNF-α (Tumor Necrosis Factor Alpha) - A key pro-inflammatory factor in insulin resistance in T2DM. Exercise improves insulin sensitivity by inhibiting the production of TNF-α. Meta-analyses confirm that exercise significantly reduces TNF-α levels in T2DM patients. hs-CRP (High-sensitivity C-reactive protein) - A classic marker of systemic low-grade inflammation, identified as a key baseline biomarker to distinguish well-controlled T2DM patients from healthy adults. |
1.4 weeks
|
|
Body Composition
Aikaikkuna: 1.4 weeks
|
DEXA to detect body fat percentage (BF%) and skeletal muscle index (SMI)
|
1.4 weeks
|
|
maximal oxygen uptake (VO₂max)
Aikaikkuna: 1.4 weeks
|
Cardiopulmonary exercise testing to determine maximal oxygen uptake (VO₂max)
|
1.4 weeks
|
Toissijaiset tulostoimenpiteet
Toissijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
|
Postprandial Blood Glucose Fluctuations
Aikaikkuna: 1.4 weeks
|
Calculate the average blood glucose values and blood glucose fluctuation coefficients (CONGA) for 2-4 hours after breakfast, lunch, and dinner by using CGM, comparing the differences before and after intervention and between groups.
CONGA is defined as the standard deviation of the differences between consecutive blood glucose measurements, reflecting the amplitude of blood glucose fluctuations.
|
1.4 weeks
|
|
Dynamic Blood Glucose Parameters
Aikaikkuna: 1.4 weeks
|
Time in Range (TIR): The percentage of time blood glucose is within the range of 3.9-10.0
mmol/L Time Above Range (TAR): The percentage of time blood glucose is >10.0 mmol/L Time Below Range (TBR): The percentage of time blood glucose is <3.9 mmol/L Mean Amplitude of Glycemic Excursions (MAGE) 24-hour average blood glucose Immediate post-exercise blood glucose decline and duration
|
1.4 weeks
|
|
Basal Metabolic Indicators
Aikaikkuna: 1.4 weeks
|
Fasting Plasma Glucose (FPG) 2-hour Postprandial Glucose (2hPG) Glycated Hemoglobin (HbA1c) Fasting Insulin (FINS) HOMA-IR Index Matsuda Insulin Sensitivity Index (ISI)
|
1.4 weeks
|
|
Anthropometric indicator
Aikaikkuna: 1.4 weeks
|
Body Mass Index (BMI) = Weight (kg) / Height (m)²
|
1.4 weeks
|
Yhteistyökumppanit ja tutkijat
Sponsori
Sponsori
Tutkijat
Tutkijat
- Opintojen puheenjohtaja: Rongfeng Zhu, The 95th Hospital of Putian
Julkaisuja ja hyödyllisiä linkkejä
Yleiset julkaisut
- Karstoft K, Winding K, Knudsen SH, Nielsen JS, Thomsen C, Pedersen BK, Solomon TP. The effects of free-living interval-walking training on glycemic control, body composition, and physical fitness in type 2 diabetic patients: a randomized, controlled trial. Diabetes Care. 2013 Feb;36(2):228-36. doi: 10.2337/dc12-0658. Epub 2012 Sep 21.
- Petersen MH, de Almeida ME, Wentorf EK, Jensen K, Ortenblad N, Hojlund K. High-intensity interval training combining rowing and cycling efficiently improves insulin sensitivity, body composition and VO2max in men with obesity and type 2 diabetes. Front Endocrinol (Lausanne). 2022 Nov 1;13:1032235. doi: 10.3389/fendo.2022.1032235. eCollection 2022.
- Xing H, Lu J, Yoong SQ, Tan YQ, Kusuyama J, Wu XV. Effect of Aerobic and Resistant Exercise Intervention on Inflammaging of Type 2 Diabetes Mellitus in Middle-Aged and Older Adults: A Systematic Review and Meta-Analysis. J Am Med Dir Assoc. 2022 May;23(5):823-830.e13. doi: 10.1016/j.jamda.2022.01.055. Epub 2022 Feb 17.
- Pedersen BK. Anti-inflammatory effects of exercise: role in diabetes and cardiovascular disease. Eur J Clin Invest. 2017 Aug;47(8):600-611. doi: 10.1111/eci.12781. Epub 2017 Jul 19.
Opintojen ennätyspäivät
Opi tärkeimmät päivämäärät
Opiskelun aloitus (Arvioitu)
Opiskelun aloitus
Ensisijainen valmistuminen (Arvioitu)
Ensisijainen valmistuminen
Opintojen valmistuminen (Arvioitu)
Opintojen valmistuminen
Opintoihin ilmoittautumispäivät
Ensimmäinen lähetetty
Ensimmäinen lähetetty
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Ensimmäinen Lähetetty (Todellinen)
Ensimmäinen Lähetetty
Tutkimustietojen päivitykset
Viimeisin päivitys julkaistu (Todellinen)
Viimeisin päivitys julkaistu
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Viimeksi vahvistettu
Viimeksi vahvistettu
Lisää tietoa
Tähän tutkimukseen liittyvät termit
Muita asiaankuuluvia MeSH-ehtoja
Muut tutkimustunnusnumerot
Muut tutkimustunnusnumerot
- 2025-js025
Yksittäisten osallistujien tietojen suunnitelma (IPD)
Aiotko jakaa yksittäisten osallistujien tietoja (IPD)?
IPD-suunnitelman kuvaus
Lääke- ja laitetiedot, tutkimusasiakirjat
Tutkii yhdysvaltalaista FDA sääntelemää lääkevalmistetta
Tutkii yhdysvaltalaista FDA sääntelemää laitetuotetta
Nämä tiedot haettiin suoraan verkkosivustolta clinicaltrials.gov ilman muutoksia. Jos sinulla on pyyntöjä muuttaa, poistaa tai päivittää tutkimustietojasi, ota yhteyttä register@clinicaltrials.gov. Heti kun muutos on otettu käyttöön osoitteessa clinicaltrials.gov, se päivitetään automaattisesti myös verkkosivustollemme .