Diabetes
Conditions
Brief summary
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.
Detailed description
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).
Interventions
BEHAVIORALContinuous 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
BEHAVIORALRowing 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
BEHAVIORALCombined 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
Sponsors
The 95th Hospital of Putian，Putian, Fujian, China
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| inflammatory cytokines | 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. |
| Body Composition | 1.4 weeks | DEXA to detect body fat percentage (BF%) and skeletal muscle index (SMI) |
| maximal oxygen uptake (VO₂max) | 1.4 weeks | Cardiopulmonary exercise testing to determine maximal oxygen uptake (VO₂max) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Postprandial Blood Glucose Fluctuations | 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. |
| Dynamic Blood Glucose Parameters | 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 |
| Basal Metabolic Indicators | 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) |
| Anthropometric indicator | 1.4 weeks | Body Mass Index (BMI) = Weight (kg) / Height (m)² |
Countries
China
Contacts
CONTACTYanxin Huang, Dr
CONTACTXuebai Chen
STUDY_CHAIRRongfeng Zhu
The 95th Hospital of Putian
Outcome results
None listed