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

ConditionDiabetes
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-60
SponsorThe 95th Hospital of Putian,Putian, Fujian, China

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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%;

Disqualifiers

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);

Trial design

Design model

Parallel

Treatments tested in this trial

  • Continuous Exercise - Cycling Group

    Behavioral

    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

  • Rowing Ergometer High-Intensity Interval Training

    Behavioral

    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

  • Combined Training Standard

    Behavioral

    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

Treatment groups

120 Participants
are divided into 4 treatment groups
Group A: Continuous Exercise - Cycling GroupActive comparator 1 intervention
Group B: Rowing Ergometer High-Intensity Interval Training (RE-HIIT)Active comparator 1 intervention
Group C: Combined Training Standard (CT-S)Experimental treatment 1 intervention
Group D: Control Group (CG)No intervention 0 interventions

Trial outcomes

Primary outcomes

1

inflammatory cytokines

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.

Time frame
1.4 weeks
2

Body Composition

DEXA to detect body fat percentage (BF%) and skeletal muscle index (SMI)

Time frame
1.4 weeks
3

maximal oxygen uptake (VO₂max)

Cardiopulmonary exercise testing to determine maximal oxygen uptake (VO₂max)

Time frame
1.4 weeks

Secondary outcomes

1

Postprandial Blood Glucose Fluctuations

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.

Time frame
1.4 weeks
2

Dynamic Blood Glucose Parameters

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

Time frame
1.4 weeks
3

Basal Metabolic Indicators

Fasting Plasma Glucose (FPG) 2-hour Postprandial Glucose (2hPG) Glycated Hemoglobin (HbA1c) Fasting Insulin (FINS) HOMA-IR Index Matsuda Insulin Sensitivity Index (ISI)

Time frame
1.4 weeks
4

Anthropometric indicator

Body Mass Index (BMI) = Weight (kg) / Height (m)²

Time frame
1.4 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

This trial is not recruiting at the moment. You can still explore other options: