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
연구 개요
상태
상태
정황
정황
개입 / 치료
개입 / 치료
상세 설명
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).
연구 유형
연구 유형
등록 (추정된)
등록
단계
단계
- 해당 없음
연락처 및 위치
연구 연락처
연구 연락처
- 이름: Xuebai Chen
- 전화번호: +8618760590880
- 이메일: Chenxuebai@126.com
연구 연락처 백업
- 이름: Yanxin Huang, Dr
- 전화번호: +8615960503382
- 이메일: 727937141@qq.com
연구 장소
-
-
Fujian
-
Putian, Fujian, 중국, 351100
- The Ethics Committee of Putian 95 Hospital
-
연락하다:
- Xuebai Chen
- 전화번호: +8618760590880
- 이메일: Chenxuebai@126.com
-
-
참여기준
자격 기준
자격 기준
공부할 수 있는 나이
- 성인
건강한 자원 봉사자를 받아들입니다
설명
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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
팔의 수
무기와 개입
참가자 그룹 / 팔참가자 그룹 / 팔 |
개입 / 치료개입 / 치료 |
|---|---|
|
활성 비교기: 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
|
|
활성 비교기: 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 |
|
실험적: 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 |
|
간섭 없음: Control Group (CG)
Maintain usual activity levels without engaging in any structured exercise training.
Daily activity levels are recorded using an accelerometer.
|
연구는 무엇을 측정합니까?
주요 결과 측정
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
inflammatory cytokines
기간: 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
기간: 1.4 weeks
|
DEXA to detect body fat percentage (BF%) and skeletal muscle index (SMI)
|
1.4 weeks
|
|
maximal oxygen uptake (VO₂max)
기간: 1.4 weeks
|
Cardiopulmonary exercise testing to determine maximal oxygen uptake (VO₂max)
|
1.4 weeks
|
2차 결과 측정
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Postprandial Blood Glucose Fluctuations
기간: 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
기간: 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
기간: 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
기간: 1.4 weeks
|
Body Mass Index (BMI) = Weight (kg) / Height (m)²
|
1.4 weeks
|
공동 작업자 및 조사자
수사관
수사관
- 연구 의자: Rongfeng Zhu, The 95th Hospital of Putian
간행물 및 유용한 링크
일반 간행물
- 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.
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
연구 시작
기본 완료 (추정된)
기본 완료
연구 완료 (추정된)
연구 완료
연구 등록 날짜
최초 제출
최초 제출
QC 기준을 충족하는 최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
처음 게시됨
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
마지막 업데이트 게시됨
QC 기준을 충족하는 마지막 업데이트 제출
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
기타 연구 ID 번호
- 2025-js025
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .