Diese Seite wurde automatisch übersetzt und die Genauigkeit der Übersetzung wird nicht garantiert. Bitte wende dich an die englische Version für einen Quelltext.

Rowing and Cycling Reduce Inflammation in Early-Stage Type 2 Diabetes

12. August 2026 aktualisiert von: The 95th Hospital of Putian，Putian, Fujian, China

Effects of Different Modes of Rowing Combined With Cycling Exercise on Inflammatory Markers in Newly Diagnosed Type 2 Diabetes Patients

This multicenter randomized controlled trial evaluates the short-term (7-day) effects of different rowing-cycling exercise regimens on postprandial glycemic excursions in newly diagnosed type 2 diabetes patients (aged 18-60 years, diagnosis ≤12 months, drug-naïve). A total of 120 participants will be randomized into five groups: control, moderate-intensity continuous cycling, high-intensity interval rowing, and standard combined exercise (rowing + cycling, 50 min). The primary outcome is inflammatory cytokines (IL-6, TNF-α, IL-1β, IL-1ra, IL-10, hs-CRP), body Composition and functional Indicators. Secondary outcomes include change in continuous glucose monitoring-derived glycemic variability (CONGA), and time-in-range. Mixed-effects models will quantify dose-response relationships and identify key effect modifiers (e.g., age). This study aims to establish an evidence-based precision exercise prescription for early-stage type 2 diabetes management.

Studienübersicht

Status

Noch keine Rekrutierung

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

Study Process

  1. 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.
  2. 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.

  3. 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)

  4. Intervention - All exercise groups train once a day for 7 consecutive days at the research centre under supervision. Heart rate is monitored throughout.
  5. 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.
  6. 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).

Studientyp

Interventionell

Einschreibung (Geschätzt)

120

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Studieren Sie die Kontaktsicherung

Studienorte

  • China
    • Fujian
      • Putian, Fujian, China, 351100
        • The Ethics Committee of Putian 95 Hospital
        • Kontakt:

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Erwachsene

Akzeptiert gesunde Freiwillige

Nein

Beschreibung

Inclusion Criteria:

  1. Age between 18-60 years, no gender limited;
  2. Meeting the WHO 1999 diagnostic criteria for T2DM, with a diagnosis time ≤12 months;
  3. Not having received hypoglycemic drug treatment (or only lifestyle intervention, and stopped medication ≥4 weeks before enrollment);
  4. Fasting blood glucose 7.0-13.9 mmol/L, glycated hemoglobin (HbA1c) 6.5%-10.0%;
  5. No regular exercise in the past 3 months (less than 2 times per week of moderate or higher intensity exercise, each <30 minutes);
  6. Voluntarily signing the informed consent form.

Exclusion Criteria:

  1. Type 1 diabetes, gestational diabetes, or other special types of diabetes;
  2. Severe cardiovascular or cerebrovascular diseases (NYHA heart function ≥III, recent myocardial infarction or unstable angina);
  3. Uncontrolled hypertension (resting systolic blood pressure ≥160 mmHg or diastolic blood pressure ≥100 mmHg);
  4. Severe liver or kidney dysfunction (ALT/AST ≥3 times the upper limit of normal, or eGFR<60 mL/min/1.73m²);
  5. Severe diabetic complications (such as proliferative retinopathy, severe neuropathy, diabetic foot);
  6. Pregnant or breastfeeding women;
  7. Mental illness or cognitive impairment that prevents compliance with the study;
  8. Stress events such as infection, trauma, or surgery in the past month;
  9. Participation in other interventional clinical studies;
  10. Musculoskeletal diseases of the upper or lower limbs that affect rowing machine or bicycle exercise.

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Single

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Aktiver Komparator: 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
Verhalten: 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
Aktiver Komparator: 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
Verhalten: Rowing Ergometer High-Intensity Interval Training

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
Experimental: 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
Verhalten: Combined Training Standard

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
Kein Eingriff: Control Group (CG)
Maintain usual activity levels without engaging in any structured exercise training. Daily activity levels are recorded using an accelerometer.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
inflammatory cytokines
Zeitfenster: 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
Zeitfenster: 1.4 weeks
DEXA to detect body fat percentage (BF%) and skeletal muscle index (SMI)
1.4 weeks
maximal oxygen uptake (VO₂max)
Zeitfenster: 1.4 weeks
Cardiopulmonary exercise testing to determine maximal oxygen uptake (VO₂max)
1.4 weeks

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Postprandial Blood Glucose Fluctuations
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 1.4 weeks
Body Mass Index (BMI) = Weight (kg) / Height (m)²
1.4 weeks

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

The 95th Hospital of Putian，Putian, Fujian, China

Ermittler

  • Studienstuhl: Rongfeng Zhu, The 95th Hospital of Putian

Publikationen und hilfreiche Links

Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.

Allgemeine Veröffentlichungen

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Geschätzt)

1. Oktober 2026

Primärer Abschluss (Geschätzt)

10. Oktober 2028

Studienabschluss (Geschätzt)

11. Dezember 2028

Studienanmeldedaten

Zuerst eingereicht

1. August 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

12. August 2026

Zuerst gepostet (Tatsächlich)

18. August 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

18. August 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

12. August 2026

Zuletzt verifiziert

1. August 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • 2025-js025

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

NEIN

Beschreibung des IPD-Plans

Some recruiters may object to public disclosure.

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

Abonnieren